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Regulations on the Supervision and Administration of Medical Devices(State Council Decree No. 680)
2017-05-06 14:16

Regulations on the Supervision and Administration of Medical Devices


 [Promulgated on January 4, 2000 (State Council Decree No. 276 in 2000), amended and adopted by the State Council at the 39th executive meeting on February 12, 2014 (State Council Decree No. 650 in 2014), and amended according to the Decision of the State Council on Amending the Regulations on Supervision and Administration of Medical Devices promulgated on May 4, 2017 (State Council Decree No. 680 in 2017)]

 

Chapter I - General Provisions

Article 1 These Regulations are hereby formulated with a view to ensuring the safety and effectiveness of medical devices and protecting human health and life safety.

Article 2 All activities in the research and development, manufacturing, supply, use, supervision and administration of medical devices within the territory of the People's Republic of China shall comply with these Regulations.

Article 3 The China Food and Drug Administration (CFDA) under the State Council is responsible for the supervision and administration of medical devices nationwide. The relevant authorities under the State Council are responsible for the supervision and administration of medical devices within their respective functions and duties.

The local Food and Drug Administration authorities at or above the county level are responsible for the supervision and administration of medical devices within their respective administrative areas. The relevant authorities under the local People's Governments at or above the county level are responsible for the supervision and administration of medical devices within their respective functions and duties.

CFDA shall cooperate with the relevant authorities under the State Council in the implementation of national plans and policies on the medical device industry.

Article 4 The State classifies and regulates medical devices on the basis of level of risk.

Class I medical devices are those at low level of risk, and their safety and effectiveness can be ensured through routine regulation;

Class II medical devices are those at middle level of risk, and strict regulation is required to ensure their safety and effectiveness;

Class III medical devices are those at high level of risk, and strict regulation with special measures are required to ensure their safety and effectiveness.

To evaluate the risk level of medical devices, the intended use, structural characteristics, method of application and other factors shall be taken into account.

CFDA is responsible for formulating the Classification Rules for Medical Devices and Classification Catalogue for Medical Devices, analyzing and evaluating the risk changes of medical devices in time according to the manufacturing, supply and use of medical devices, and adjusting the Classification Catalogue. To formulate and adjust the Classification Catalogue, opinions from medical device manufacturing and supply enterprises, entities using medical devices and industry organizations shall be fully listened to, and the practice of international medical device classification shall be used for reference. The Classification Catalogue for Medical Devices shall be promulgated to the public.

Article 5 The research and development of medical devices shall follow the principles of safety, effectiveness and economy. The State encourages the research and innovation of medical devices, with a view to promoting the popularization and application of new technologies concerning medical devices and pushing forward the development of medical device industry, through bringing into play the role of market mechanisms.

Article 6 Medical devices shall comply with the mandatory national standards. In case of absence of mandatory national standards, mandatory industry standards shall be complied with.

The Catalogue of Single-Use Medical Devices shall be formulated, adjusted and promulgated by CFDA jointly with the National Health and Family Planning Commission (NHFPC) under the State Council. Medical devices which can be repeatedly used on the premise of ensuring safety and effectiveness shall not be listed in the Catalogue of Single-Use Medical Devices. The Catalogue of Single-Use Medical Devices shall be adjusted if some single-use medical devices can be repeatedly used on the premise of ensuring safety and effectiveness after the design, manufacturing process and disinfection & sterilization techniques are improved.

Article 7 Medical device industry organizations shall enhance self-discipline, promote the construction of trustworthiness system, supervise and urge enterprises to conduct manufacturing and supply activities according to law, and guide enterprises to be honest and trustworthy.

 

Chapter II - Medical Device Registration and Recording

Article 8 Class I medical devices shall be regulated through recording, and Class II/III medical devices shall be regulated through registration.

Article 9 The following dossiers shall be submitted for the recording application of a Class I medical device and the registration application of a Class II/III medical device:

(1)    Risk analysis report;

(2)    Product technical requirements (PTR);

(3)    Product test report;

(4)    Clinical evaluation data;

(5)    Instructions for Use and label design drafts;

(6)    Quality Management System (QMS) documents related to product development and manufacturing;

(7)    Other data required to prove the safety and effectiveness of the product.

The medical device registration/recording applicant shall be responsible for the authenticity of the dossiers submitted.

Article 10 For a domestic Class I medical device, the recording applicant shall submit recording dossiers to the Food and Drug Administration authority at the level of city with sub-districts where the recording applicant is located. The product test report can be the self-test report from the applicant. The clinical evaluation data do not include clinical trial report, and can be data which can prove the safety and effectiveness of the medical device to be recorded through relevant literatures and data obtained from the clinical applications of the predicate device(s).

Any overseas manufacturing enterprise that intends to export a Class I medical device to China shall entrust its representative office within the territory of the People's Republic of China as its Agent or designate a corporate body within the territory of the People's Republic of China as its Agent. The Agent shall submit the recording dossiers and the supporting documents certifying that this medical device to be recorded has been approved to enter the market in the country (or region) where the recording applicant is located to CFDA.

In case of changes to the contents specified in the recording dossiers of an approved Class I medical device, the Marketing Authorization Holder (MAH) shall apply to the original Food and Drug Administration authority responsible for the recording approval for the change of recording information.

Article 11 For a domestic Class II medical device, the registration applicant shall submit registration application dossiers to the Food and Drug Administration authority at the level of province, autonomous region or municipality where the registration applicant is located. For a domestic Class III medical device, the registration applicant shall submit registration application dossiers to CFDA.

Any overseas manufacturing enterprise that intends to export a Class II/III medical device to China shall entrust its representative office within the territory of the People's Republic of China as its Agent or designate a corporate body within the territory of the People's Republic of China as its Agent. The Agent shall submit the registration application dossiers and the supporting documents certifying that this medical device to be registered has been approved to enter the market in the country (or region) where the registration applicant is located to CFDA.

The product test report for a Class II/III medical device shall be issued by a medical device testing institute. The clinical evaluation data shall include clinical trial report (not applicable to those medical devices exempted from clinical trials in accordance with Article 17).

Article 12 The Food and Drug Administration authority that accepts the registration application shall forward the application dossiers to its Center for Medical Device Evaluation within three working days upon the date of acceptance. The Center for Medical Device Evaluation shall submit its review opinions to the Food and Drug Administration authority after the technical review is completed.

Article 13 The Food and Drug Administration authority that accepts the registration application shall make a decision within 20 working days after receiving the review opinions from its Center for Medical Device Evaluation. The medical device meeting the requirements of safety and effectiveness shall be approved for registration and the Medical Device Registration Certificate shall be issued accordingly. As for the medical device which fails to meet relevant requirements, the application shall not be approved and a written justification for disapproval shall be provided.

When CFDA considers it necessary to audit the quality management system (QMS) of the overseas manufacturer during the technical review on an imported medical device, CFDA shall organize special QMS technical group to conduct on-site QMS audit.

Article 14 In case of substantial changes to the design, raw materials, manufacturing process, scope of application and method of application of an approved Class II/III medical device, which may affect the safety and effectiveness of the device, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for registration change. In case of insubstantial changes that do not affect the safety and effectiveness of the medical device, the changes shall be submitted to the original Food and Drug Administration authority responsible for the registration approval for recording.

Article 15 The Medical Device Registration Certificate is valid for five years. If the Medical Device Registration Certificate needs to be renewed due to expiry, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for registration renewal no later than six months prior to the expiry date of the Certificate.

With the exception of the circumstances specified in the third paragraph of this Article, the Food and Drug Administration authority that receives the application for registration renewal shall make a decision on whether to approve the renewal application or not before the expiry date of the Medical Device Registration Certificate. If the Food and Drug Administration authority fails to make a decision within the time limit, the renewal application shall be deemed to have been approved.

Under any of the following circumstances, the application for registration renewal shall not be approved:

(1)    The MAH fails to apply for registration renewal within the stipulated time;

(2)    The mandatory standards for medical devices have been revised, while the medical device subject to registration renewal fails to meet the new requirements;

(3)    As for a medical device used for treating rare diseases or urgently needed for dealing with public health emergencies, the MAH fails to complete the items specified in the Medical Device Registration Certificate within the stipulated time.

Article 16 As for a newly-developed medical device that has not yet been listed in the Classification Catalogue for Medical Devices, the applicant may directly apply for CFDA registration in accordance with the relevant requirements on the registration of Class III medical devices set forth in these Regulations, or apply for product registration or recording after judging the product classification based on the classification rules and applying to CFDA for the classification determination.

As for a medical device directly applied for registration as a Class III medical device, CFDA shall determine the classification according to the risk level of the device, and include the approved medical device in the Classification Catalogue for Medical Devices in time. As for a medical device applied for classification determination, CFDA shall determine the classification within 20 working days upon the date of acceptance and inform the applicant of the result of classification determination.

Article 17 Clinical trials are not required for Class I medical device recording. In the case of registration application for a Class II/III medical device, clinical trials shall be conducted. However, under any of the following circumstances, clinical trials may be exempted:

(1)    The medical device to be registered has clear working mechanism, finalized design and mature manufacturing process; the predicate device (similar device already on the market) has been in clinical application for many years without severe adverse events; and the medical device to be registered doesn't change the general purposes;

(2)    The safety and effectiveness of the medical device to be registered can be proved through non-clinical evaluation;

(3)    The safety and effectiveness of the medical device to be registered can be proved through the analysis and evaluation on the data obtained from the clinical trials or clinical applications of the predicate device.

The Catalogue of Medical Devices Exempted from Clinical Trials shall be formulated, adjusted and promulgated by CFDA.

Article 18 Medical device clinical trials shall be conducted in the certified clinical trial institutions in accordance with the requirements of the Good Clinical Practice for Medical Devices, and shall be applied to the Food and Drug Administration authority at the level of province, autonomous region or municipality where the sponsor is located for recording. The Food and Drug Administration authority that accepts the clinical trial recording shall report to the Food and Drug Administration authority and the Health and Family Planning Commission authority at the same level where the clinical trial institution is located.

Medical device clinical trial institutions shall be regulated through recording. Provisions on the Conditions and Recording of Medical Device Clinical Trial Institutions and the Good Clinical Practice for Medical Devices shall be formulated and promulgated by CFDA jointly with NHFPC.

Article 19 Clinical trials for Class III high-risk medical devices shall be approved by CFDA before initiation. The Catalogue of Class III High-Risk Medical Devices Requiring CFDA Approval for Clinical Trials shall be formulated, adjusted and promulgated by CFDA.

CFDA shall, when examining and approving clinical trials, make a comprehensive analysis on the equipment, professionals and other conditions of clinical trial institutions that intend to undertake the trials, and the level of risk, clinical trial protocol, and clinical benefit-risk comparative analysis report of the investigational medical device. If a clinical trial is approved for initiation, CFDA shall inform the sponsor, the Food and Drug Administration authorities and the Health and Family Planning Commission authorities at the level of province, autonomous region or municipality where the clinical trial institutions are located.

 

Chapter III - Medical Device Manufacturing

Article 20 Any enterprise that intends to engage in medical device manufacturing shall:

(1)    Be equipped with manufacturing sites, environmental conditions, production equipment and technical professionals appropriate to the medical devices to be manufactured;

(2)    Be equipped with inspection departments or full-time inspection personnel, as well as inspection equipment for quality inspection of the medical devices to be manufactured;

(3)    Establish a management system that can guarantee the quality of medical devices;

(4)    Possess after-sales service capacity appropriate to the medical devices to be manufactured;

(5)    Meet the requirements specified in product development and production process documents.

Article 21 Any manufacturing enterprise that intends to engage in the manufacture of a Class I medical device shall apply to the local Food and Drug Administration authority at the level of city with sub-districts for manufacturing recording, and submit proof that it meets the conditions stipulated in Article 20.

Article 22 Any manufacturing enterprise that intends to engage in the manufacture of a Class II/III medical device shall apply to the local Food and Drug Administration authority at the level of province, autonomous region or municipality for manufacturing licensing, and submit proof that it meets the conditions stipulated in Article 20 and the Registration Certificate of the medical device to be manufactured.

The Food and Drug Administration authority that accepts the application for manufacturing licensing shall review the application dossiers within 30 working days upon the date of acceptance, and carry out on-site audit according to the Good Manufacturing Practice for Medical Devices formulated by CFDA. Where the prescribed requirements are met, the application shall be approved and the Medical Device Manufacturing License shall be issued. Where the prescribed requirements are not met, a decision of disapproval shall be made and a written justification for disapproval shall be provided.

The Medical Device Manufacturing License is valid for 5 years. If the Medical Device Manufacturing License needs to be renewed due to expiry, the licensing renewal shall be conducted in accordance with the relevant laws and regulations on administrative licensing.

Article 23 The Good Manufacturing Practice for Medical Devices shall clarify the specific requirements for those aspects affecting the safety and effectiveness of medical devices, such as, the design and development of medical devices, production equipment conditions, raw material purchasing, production process control, organizational structure and personnel of the enterprise, and so on.

Article 24 Medical device manufacturing enterprises shall establish and maintain a Quality Management System (QMS) appropriate to the medical devices manufactured based on the requirements of the Good Manufacturing Practice for Medical Devices and shall keep the effective operation of the System. Medical device manufacturing enterprises shall carry out manufacturing activities in strict accordance with the approved (through registration/recording) Product Technical Requirements (PTR), and ensure that all delivered devices comply with the mandatory standards as well as the approved PTR.

Medical device manufacturing enterprises shall conduct self-inspection of the QMS operation periodically, and submit the self-inspection report to the local Food and Drug Administration authority at the level of province, autonomous region or municipality.

Article 25 If the production conditions of a medical device manufacturing enterprise change and do not meet the QMS requirements any more, the medical device manufacturing enterprise shall immediately take corrective measures. If the changes may affect the safety and effectiveness of medical devices, the medical device manufacturing enterprise shall immediately stop the relevant manufacturing activities and report to the local Food and Drug Administration authority at the county level.

Article 26 A medical device shall be named with a generic name, which shall be in compliance with the Naming Rules for the Generic Names of Medical Devices formulated by CFDA.

Article 27 A medical device shall be accompanied with Instructions for Use and labels. The Instructions for Use and labels supplied together with the medical device shall be consistent with the approved (through registration/recording) ones.

The Instructions for Use and labels of a medical device shall contain the following particulars:

(1)    Generic name, models and specifications of the medical device;

(2)    Name, address, manufacturing site, and contact information of the manufacturing enterprise;

(3)    No. of Product Technical Requirements (PTR);

(4)    Date of manufacture, service life or expiry date;

(5)    Product performance, main structural components, scope of application;

(6)    Contraindications, precautions, warnings and other information should be noticed;

(7)    Instructions or graphic guidance for installation and use;

(8)    Product maintenance methods, special storage conditions and methods;

(9)    Other information which shall be indicated based on the Product Technical Requirements (PTR).

As for a Class II/III medical device, No. of Medical Device Registration Certificate, the name, address and contact information of the MAH shall also be indicated.

For those devices used by the customers themselves, special instructions for safe use shall also be indicated.

Article 28 In case of contract manufacturing, the Entrusting Party shall take the responsibility for the quality of medical devices manufactured. The Entrusted Party shall be a medical device manufacturing enterprise that meets the requirements of these Regulations and is provided with corresponding production conditions. The Entrusting Party shall strengthen the management of manufacturing activities of the Entrusted Party so as to ensure that manufacturing activities are carried out in accordance with the regulatory requirements.

The contract manufacturing for high-risk implantable medical devices is not allowed. The specific catalogue shall be formulated, adjusted and promulgated by CFDA.

 

Chapter IV - Medical Device Supply and Use

Article 29 Any enterprise engaging in medical device supply activities shall be equipped with site(s) for medical device supply and storage conditions appropriate to its supply scale and scope, as well as a quality control system and a quality control department or quality control personnel appropriate to the medical device it supplies.

Article 30 Any supply enterprise that intends to engage in the supply of a Class II medical device shall apply to the local Food and Drug Administration authority at the level of city with sub-districts for supply recording, and submit proof that it meets the conditions stipulated in Article 29.

Article 31 Any supply enterprise that intends to engage in the supply of a Class III medical device shall apply to the local Food and Drug Administration authority at the level of city with sub-districts for supply licensing, and submit proof that it meets the conditions stipulated in Article 29.

The Food and Drug Administration authority that accepts the application for supply licensing shall review the application dossiers within 30 working days upon the date of acceptance, and carry out on-site audit when necessary. Where the prescribed requirements are met, the application shall be approved and the Medical Device Supply License shall be issued. Where the prescribed requirements are not met, a decision of disapproval shall be made and a written justification for disapproval shall be provided.

The Medical Device Supply License is valid for 5 years. If the Medical Device Supply License needs to be renewed due to expiry, the licensing renewal shall be conducted in accordance with the relevant laws and regulations on administrative licensing.

Article 32 When purchasing medical devices, medical device supply enterprises or the entities using medical devices shall check the qualification of the supplier and the certificate of conformity of the related medical devices, and shall establish an incoming inspection record system. Supply enterprises wholesaling Class II/III medical devices or retailing Class III medical devices shall also establish a sales record system.

The following particulars shall be recorded:

(1)    Name, models & specifications, and quantity of medical device;

(2)    Batch/lot number, expiration date and sales date of medical device;

(3)    Name of the medical device manufacturing enterprise;

(4)    Name, address and contact information of supplier or purchaser of medical device;

(5)    No. of relevant approval documents.

The incoming inspection records and sales records shall be authentic, and shall be kept within the time limit stipulated by CFDA. The State encourages the use of advanced technical means to establish the above-mentioned record systems.

Article 33 Medical devices shall be transported and stored in accordance with the requirements specified in the Instructions for Use and labels. If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 34 Entities using medical devices shall be equipped with storage sites and conditions appropriate to the type and quantity of medical devices in use. Entities using medical devices shall strengthen the technical training of the staff and make sure that medical devices are used in accordance with Instructions for Use, standard operation procedures and other requirements.

Entities allocating large-scale medical equipment shall conform to the Plan of Large-scale Medical Equipment Allocation formulated by NHFPC. The allocation shall be compatible with the functional orientation and clinical service needs of the entities. Entities allocating large-scale medical equipment shall be equipped with corresponding technical conditions, supporting facilities and professional and technical personnel with corresponding qualifications and capabilities. The allocation shall be approved by the Health and Family Planning Commission authority at or above the provincial level, to obtain the Large-scale Medical Equipment Allocation License.

The Administrative Measures on the Allocation of Large-scale Medical Equipment shall be formulated by NHFPC jointly with the relevant authorities under the State Council. The Catalogue of Large-scale Medical Equipment shall be proposed by NHFPC in consultation with the relevant authorities under the State Council, and shall apply after being approved by the State Council.

Article 35 Entities using medical devices shall disinfect and manage reusable medical devices in accordance with the relevant regulations formulated by NHFPC.

Single-use medical devices are not allowed to be reused. The single-use medical devices which have been used shall be destroyed and recorded in accordance with the relevant national regulations.

Article 36 As for the medical devices needing to be checked, inspected, calibrated and maintained periodically, entities using these medical devices shall check, inspect, calibrate and maintain these medical devices in accordance with the Instructions for Use and make records accordingly, as well as perform analysis and evaluation in time to ensure that medical devices are in good condition and to guarantee the good performance of medical devices. Besides, a service logbook shall be created for every large-scale medical device with a long service life, to keep the records concerning its in-service use, maintenance, transfer and the actual service time, etc. The records shall be kept for at least five years after the end of the specified service life of medical device.

Article 37 Entities using medical devices shall properly keep the source information of the purchased Class III medical devices, and shall ensure the traceability of the information.

Entities using large-scale medical devices and implantable or invasive medical devices shall record the name, key technical parameters and other information of the medical devices as well as the necessary information closely related to the safety of use of the medical devices in relevant records such as medical records.

Article 38 If any potential safety hazard is found in a medical device in use, the entity using the medical device shall stop using the medical device immediately and inform the manufacturing enterprise or other entities responsible for the product quality to perform troubleshooting. The medical device shall not be used any more if it fails to meet the safety criteria for use after the troubleshooting.

Article 39 The Food and Drug Administration authorities shall supervise and administrate the quality of medical devices in use; and the Health and Family Planning Commission authorities shall supervise and administrate the use of medical devices.

Article 40 Medical device supply enterprises and entities using medical devices shall not supply and use those medical devices that are not approved according to law, that have no certificates of conformity as well as those that are expired, ineffective or disused.

Article 41 Where a medical device in use is transferred between entities using medical devices, the transferor shall ensure the medical device transferred is safe and effective. It is not allowed to transfer expired, ineffective, disused or unqualified medical devices.

Article 42 Imported medical devices shall be approved (through registration/recording) in accordance with the requirements set forth in Chapter II before being placed on the Chinese market.

An imported medical device shall be accompanied with Instructions for Use in Chinese and labels in Chinese. Instructions for Use and labels shall meet the requirements of these Regulations and the relevant mandatory standards. The country (region) of origin of the medical device, and the name, address and contact information of the Agent in China shall be specified in the Instructions for Use. Those medical devices without Instructions for Use in Chinese or labels in Chinese or those whose Instructions for Use and labels fail to meet the requirements set forth in this Article are not allowed to be imported.

Article 43 China Inspection and Quarantine authorities (CIQ) shall inspect the imported medical devices according to law. Those disqualified devices upon inspection are not allowed to be imported.

CFDA shall report the approval status (registration/recording) of the imported medical devices to CIQ in time. The CIQ where the import port is located shall report the customs clearance status of the imported medical devices to the local Food and Drug Administration authority at the level of city with sub-districts in time.

Article 44 Enterprises exporting medical devices shall ensure that their export medical devices meet the requirements of the importing country (region).

Article 45 Advertisements of medical devices shall be authentic and legal, and shall not include false, exaggerated and misleading contents.

An advertisement of a medical device shall be examined and approved by the Food and Drug Administration authority at the level of province, autonomous region or municipality where the medical device manufacturing enterprise (applicable to domestic medical device) or the Agent (applicable to imported medical device) is located, and the approval document for medical device advertisement shall be acquired. The advertisement publisher shall check the approval document of the advertisement and its authenticity in advance before publishing the medical device advertisement. Under any of the following circumstances, the medical device advertisement shall not be published: 1) the approval document of the advertisement has not been acquired; 2) the authenticity of the approval document has not been verified; or 3) the content of the advertisement is not consistent with the approval document. The Food and Drug Administration authorities at the level of province, autonomous region or municipality shall publish and timely update the Catalogue of Approved Medical Device Advertisements as well as the approved contents of the advertisements.

Where the manufacturing, distribution, import and use of a medical device has been ordered to be suspended by the Food and Drug Administration authority at or above the provincial level, any advertisement related to this medical device shall not be published during the suspension.

The Provisions on the Examination of Medical Device Advertisements shall be formulated by CFDA jointly with the State Administration for Industry & Commerce of the People's Republic of China (SAIC).

 

Chapter V - Adverse Event Handling and Medical Device Recalls

Article 46 The State shall establish the monitoring system for medical device adverse events, and shall collect, analyze, evaluate and control medical device adverse events in a timely manner.

Article 47 Medical device manufacturing enterprises, medical device supply enterprises or entities using medical devices shall carry out adverse event monitoring of medical devices manufactured, supplied or used. Medical device adverse events or suspicious adverse events discovered shall be reported to the Centers for Medical Device Adverse Event Monitoring in accordance with the requirements of CFDA.

Any entity or individual who discovers medical device adverse events or suspicious adverse events shall have the right to report these events to the Food and Drug Administration authorities or the Centers for Medical Device Adverse Event Monitoring.

Article 48 CFDA shall strengthen the construction of information network for medical device adverse event monitoring.

The Centers for Medical Device Adverse Event Monitoring shall strengthen the information monitoring for medical device adverse events and actively collect information about adverse events. When discovering adverse events or receiving adverse event reports, the Centers for Medical Device Adverse Event Monitoring shall verify, investigate, analyze and evaluate the adverse events in time, and put forward suggestions concerning the adverse event handling to the Food and Drug Administration authorities and the Health and Family Planning Commission authorities.

The Centers for Medical Device Adverse Event Monitoring shall publish their contact information to facilitate medical device manufacturing enterprises, medical device supply enterprises and entities using medical devices to report medical device adverse events.

Article 49 The Food and Drug Administration authorities shall, according to the evaluation results of medical device adverse events, take timely control measures, such as, issuing warning information, ordering the suspension of manufacturing, distribution, import and use of the medical device involved, etc.

The Food and Drug Administration authorities at or above the provincial level shall, jointly with the Health and Family Planning Commission authorities and other relevant authorities at the same level, organize timely investigation and handling of medical device adverse events that have caused unexpected or mass serious injuries or deaths, and organize to strengthen monitoring of similar medical devices.

Article 50 Medical device manufacturing enterprises, medical device supply enterprises and entities using medical devices shall cooperate with the investigation of medical device adverse events carried out by the Centers for Medical Device Adverse Event Monitoring and the Food and Drug Administration authorities.

Article 51 Under any of the following circumstances, the Food and Drug Administration authority at or above the provincial level shall organize re-evaluation of the approved medical device:

(1)    There has been a change in understanding of the safety and effectiveness of the medical device according to the development of scientific research;

(2)    The monitoring and evaluation results of medical device adverse events indicate that the medical device may have defects;

(3)    Other circumstances under which the medical device shall be reevaluated based on the requirements of CFDA.

Where the reevaluation results show that the approved medical device fails to ensure its safety and effectiveness, the original certificate-issuing authority shall cancel the Medical Device Registration Certificate and announce such results to the public. Once the Medical Device Registration Certificate is cancelled, the medical device concerned shall not be manufactured, imported, supplied and used any more.

Article 52 If a medical device manufacturing enterprise discovers that the medical device it manufactures fails to meet the mandatory standards or the approved (through registration/recording) Product Technical Requirements (PTR), or has other defects, it shall: 1) immediately stop the relevant manufacturing activities, 2) inform the relevant medical device supply enterprises, entities using medical devices and consumers to stop supplying or using the devices involved, 3) recall the devices involved that have been made available on the market, 4) take remedial measures or destroy the devices, 5) record and publish relevant information, and 6) report the recall and handling of the devices involved to the relevant Food and Drug Administration authority and the Health and Family Planning Commission authority.

If a medical device supply enterprise discovers that the medical device it supplies fails to meet the mandatory standards or the approved (through registration/recording) Product Technical Requirements (PTR), or has other defects, it shall: 1) immediately discontinue the relevant supply activities, 2) inform the relevant medical device manufacturing enterprise, entities using medical devices and consumers, and 3) record the activities mentioned in 1) and 2). The medical device manufacturing enterprise involved shall immediately recall the medical devices that need to be recalled in accordance with the preceding paragraph.

Where the medical device manufacturing enterprise fails to recall the devices or the medical device supply enterprise fails to discontinue supply activities in accordance with this Article, the relevant Food and Drug Administration authority has the right to order the manufacturing/supply enterprise to recall the devices involved or discontinue the relevant supply activities.

 

Chapter VI - Supervision and Inspection

Article 53 The Food and Drug Administration authorities shall strengthen supervision and inspection on the registration, recording, manufacturing, supply and use of medical devices, and shall focus on the supervision and inspection of the following items:

(1)    Whether a medical device manufacturing enterprise carries out manufacturing activities in accordance with the approved (through registration/recording) Product Technical Requirements (PTR) or not;

(2)    Whether a medical device manufacturing enterprise keeps the effective operation of its Quality Management System (QMS) or not;

(3)    Whether the production conditions of a medical device manufacturing enterprise or the supply conditions of a medical device supply enterprise consistently meet the regulatory requirements or not.

Article 54 The Food and Drug Administration authorities have the following rights during supervision and inspection:

(1)    Perform on-site inspection and field sampling;

(2)    Review, copy, seal up and detain relevant contracts, bills, books of accounts, and other related materials;

(3)    Seal up and detain 1) those medical devices that fail to meet the regulatory requirements, 2) illegally-used parts and accessories and raw materials, and 3) the tools or equipment used for illegal production of medical devices;

(4)    Seal up the sites used for medical device manufacturing/supply activities in violation of the provisions of these Regulations.

When conducting supervision and inspection, the Food and Drug Administration authorities shall show their law-enforcement certificates and keep the business secrets of the entities being inspected.

The relevant entities and individuals shall cooperate with the supervision and inspection carried out by the Food and Drug Administration authorities, and shall not conceal any relevant information.

Article 55 As for the medical devices that have caused harm to human body, or the devices that may endanger human health based on evidence, the Food and Drug Administration authorities have the right to take emergency control measures to suspend the manufacturing, import, supply and use of these medical devices.

Article 56 The Food and Drug Administration authorities shall strengthen the random inspection on the medical devices manufactured, supplied or used by medical device manufacturing enterprises, medical device supply enterprises or entities using medical devices, respectively. Inspection fees and any other fees are not allowed to be charged for the random inspection, the costs needed for the random inspection shall be included in the government budget at the corresponding level. The Food and Drug Administration authorities at or above the provincial level shall publish medical device quality announcements in a timely manner according to the random inspection results.

The Health and Family Planning Commission authorities shall supervise and evaluate the use of large-scale medical equipment. The illegal use of large-scale medical equipment as well as the over-examination or over-treatment related to large-scale medical equipment found shall be corrected immediately and dealt with according to law.

Article 57 The qualification authentication for medical device testing institutes shall be managed in a unified manner in accordance with the relevant provisions of the State. Only the testing institutes officially recognized by the Certification and Accreditation Administration of the People's Republic of China (CNCA) jointly with CFDA can perform tests for medical devices.

If the Food and Drug Administration authority considers during law enforcement that a medical device needs to be tested, it shall entrust a qualified medical device testing institute and pay relevant testing fees accordingly.

When having any objection to the test results, the party involved can apply to a qualified medical device testing institute for a retest within seven working days upon the date of receiving the test results. The testing institute performing the retest shall issue the retest results within the time limit stipulated by CFDA. The retest results shall be the final test results.

Article 58 Where the medical devices that may contain hazardous substances or the devices that have potential safety hazards due to some unauthorized modifications in the design, raw materials and the production process cannot be tested according to the test items and test methods specified in the relevant national standards and industry standards, the medical device testing institute may perform the tests by supplementing extra test items and test methods. After being approved by CFDA, the test results obtained by using supplementary test items and test methods can be used as the basis for the Food and Drug Administration authorities to identify the quality of these medical devices.

Article 59 The Food and Drug Administration authorities at the level of city with sub-districts and at the county level shall strengthen the supervision and inspection on medical device advertisements, and shall report to the local Food and Drug Administration authorities at the level of province, autonomous region or municipality when discovering unapproved advertisements or discovering that the approved advertisement contents are tampered with. The local Food and Drug Administration authorities at the level of province, autonomous region or municipality shall announce such results to the public.

The AIC (Administration for Industry & Commerce) authorities shall conduct supervision and inspection on medical device advertisements, and investigate and prosecute the illegal activities in accordance with the relevant laws and administrative regulations on advertising management. When discovering illegal medical device advertising activities, the Food and Drug Administration authorities shall put forward handling suggestions and hand them over to the local AIC authorities at the same level in accordance with relevant procedures.

Article 60 CFDA shall establish a unified information platform for the supervision and administration of medical devices. The Food and Drug Administration authorities shall, through the information platform, timely publish information on the routine supervision and administration, such as medical device licensing, recording, random inspection, investigation and prosecution of illegal activities, etc. However, it is not allowed to disclose the commercial secrets of the parties involved.

The Food and Drug Administration authorities shall establish credit records for medical device MAHs (Marketing Authorization Holders), medical device manufacturing enterprises, medical device supply enterprises and entities using medical devices, and shall increase the frequency of supervision and inspection for those with bad credit records.

Article 61 The Food and Drug Administration authorities shall publish their own contact information to receive consultations, complaints, and reports on illegal activities. The Food and Drug Administration authorities shall timely reply to the consultations related to the supervision and administration of medical devices, and shall timely verify, deal with and reply to the complaints and reports on illegal activities received. The details of the consultations, complaints and reports on illegal activities, as well as the corresponding response, verification and handling activities shall be recorded and maintained.

Where a report on illegal activities related to the development, manufacturing, supply or use of medical devices is verified to be true through investigation, the Food and Drug Administration authority and other related authorities shall reward the informant accordingly.

Article 62 When formulating, adjusting and revising the catalogues prescribed in these Regulations and the provisions related to the supervision and administration of medical devices, CFDA shall solicit public opinions, and listen to the suggestions from experts, medical device manufacturing enterprises, medical device supply enterprises, entities using medical devices, consumers and other related organizations by holding hearings or discussion meetings.

 

Chapter VII - Legal Liabilities

Article 63 Under any of the following circumstances, the Food and Drug Administration authority at or above the county level shall confiscate the illegal income, the medical devices illegally manufactured or supplied, and the tools, equipment, raw materials and other articles used for illegal manufacturing/supply activities. If the value of the medical devices illegally manufactured or supplied is less than ¥ 10,000, the enterprise involved shall be imposed a fine of no less than ¥ 50,000 but no more than ¥ 100,000. If the value of the medical devices illegally manufactured or supplied is more than ¥ 10,000, the enterprise involved shall be imposed a fine of no less than 10 times but no more than 20 times of the value. In serious cases, any medical device licensing application submitted by the relevant responsible individual or enterprise shall not be accepted within five years:

(1)   Engage in the manufacture or supply of a Class II/III medical device without Medical Device Registration Certificate;

(2)   Engage in the manufacture of a Class II/III medical device in the absence of Manufacturing License;

(3)   Engage in the supply of a Class III medical device in the absence of Supply License.

In serious cases as prescribed in point (1) of the preceding paragraph, the original license-issuing authority shall revoke the Medical Device Manufacturing License or the Medical Device Supply License.

In case of unapproved allocation and use of large-scale medical equipment, the Health and Family Planning Commission authority at or above the county level shall order the entity involved to stop using the relevant large-scale medical equipment, give a warning accordingly and confiscate the illegal income. If the illegal income is less than ¥ 10,000, the entity involved shall be imposed a fine of no less than ¥ 10,000 but no more than ¥ 50,000. If the illegal income is more than ¥ 10,000, the enterprise involved shall be imposed a fine of no less than 5 times but no more than 10 times of the illegal income. In serious cases, any licensing application for the allocation of large-scale medical equipment submitted by the relevant responsible individual or entity shall not be accepted within five years.

Article 64 Any licensing certificate (Medical Device Registration Certificate, Medical Device Manufacturing License, Medical Device Supply License, Large-scale Medical Equipment Allocation License, or Approval Document for Medical Device Advertisement) obtained by providing false information or by other deceptive means shall be revoked by the original certificate-issuing authority. The party involved shall be imposed a fine of no less than ¥ 50,000 but no more than ¥ 100,000. Any medical device licensing application submitted by the relevant responsible individual or entity shall not be accepted within five years.

Any Medical Device Licensing Certificate is not allowed to be forged, altered, transacted, leased or lent, in case of any violation, the Certificate shall be seized or revoked by the original certificate-issuing authority. If the illegal income is less than ¥ 10,000, the party involved shall be imposed a fine of no less than ¥ 10,000 but no more than ¥ 30,000. If the illegal income is more than ¥ 10,000, the party involved shall be imposed a fine of no less than three times but no more than five times of the illegal income. Any activity against the public security administration shall be given a public security administrative punishment by the Public Security Organ.

Article 65 Any party that fails to apply for the required recording in accordance with the requirements of these Regulations shall be ordered by the Food and Drug Administration authority at or above the county level to take corrective measures within a time limit. If the party involved fails to take corrective measures within the time limit, the Food and Drug Administration authority at or above the county level shall publish the information of the party and the medical device involved to the public, and the party involved can be imposed a fine of no more than ¥ 10,000.

In case that the applicant provides false information when applying for product recording, the Food and Drug Administration authority at or above the county level shall publish the information of the recording applicant and the medical device involved to the public. In serious cases, the directly responsible individual shall not engage in medical device manufacturing or supply activities within five years.

Article 66 Under any of the following circumstances, the Food and Drug Administration authority at or above the county level shall order the party involved to take corrective measures, confiscate the medical devices illegally manufactured, supplied or used. If the value of the medical devices illegally manufactured, supplied or used is less than ¥ 10,000, the party involved shall be imposed a fine of no less than ¥ 20,000 but no more than ¥ 50,000. If the value of the medical devices illegally manufactured, supplied or used is more than ¥ 10,000, the party involved shall be imposed a fine of no less than 5 times but no more than 10 times of the value. In serious cases, the party involved shall be ordered to suspend production or business operation, and the relevant Medical Device Registration Certificate, Medical Device Manufacturing License or Medical Device Supply License shall be revoked by the original certificate-issuing authority:

(1)    Manufacture, supply or use medical devices that fail to meet the mandatory standards or the approved (through registration/recording) Product Technical Requirements (PTR);

(2)    A medical device manufacturing enterprise fails to carry out manufacturing activities in accordance with approved (through registration/recording) Product Technical Requirements (PTR), or fails to establish and keep the effective operation of the Quality Management System (QMS) in accordance with the requirements of these Regulations;

(3)    Supply or use medical devices without certificates of conformity, medical devices that are expired, ineffective or disused, or medical devices that are not approved according to law;

(4)    Refuse to recall medical devices or refuse to stop the supply activities in accordance with these Regulations as required by the Food and Drug Administration authority;

(5)    Entrust an enterprise that does not meet the requirements prescribed in these Regulations to carry out manufacturing activities, or fail to manage the manufacturing activities of the Entrusted Party.

In case that a medical device supply enterprise or an entity using medical devices has fulfilled the obligations of incoming inspection as required in these Regulations, can provide sufficient evidence to prove that they do not know the medical devices they supplied or used are the ones specified in points (1) and (3) of the preceding paragraph, and can truthfully explain the sources of purchase, the medical device supply enterprise or the entity using medical devices can be exempted from punishment. However, medical devices supplied or used failing to meet the regulatory requirements shall be confiscated according to law.

Article 67 Under any of the following circumstances, the Food and Drug Administration authority at or above the county level shall order the party involved to take corrective measures, and the party involved shall be imposed a fine of no less than ¥ 10,000 but no more than ¥ 30,000. In serious cases, the party involved shall be ordered to suspend production or business operation, and the relevant Medical Device Manufacturing License or Medical Device Supply License shall be revoked by the original license-issuing authority:

(1)    A medical device manufacturing enterprise fails to take corrective measures, stop manufacturing activities or report to the competent authority in accordance with these Regulations when the production conditions change and no longer meet the QMS requirements;

(2)    Manufacture or supply medical devices whose Instructions for Use or labels do not conform to the provisions of these Regulations;

(3)    Fail to transport or store medical devices in accordance with the requirements indicated in the Instructions for Use and labels;

(4)    Transfer expired, ineffective, disused or unqualified medical devices.

Article 68 Under any of the following circumstances, the Food and Drug Administration authority and the Health and Family Planning Commission authority at or above the county level shall, on the basis of their respective duties, order the party involved to take corrective measures and give a warning accordingly. If the party involved refuses to take corrective measures, the party involved shall be imposed a fine of no less than ¥ 5,000 but no more than ¥ 20,000. In serious cases, the party involved shall be ordered to suspend production or business operation, and the relevant Medical Device Manufacturing License or Medical Device Supply License shall be revoked by the original license-issuing authority:

(1)    A medical device manufacturing enterprise fails to submit the QMS self-inspection report as required;

(2)    A medical device supply enterprise or an entity using medical devices fails to establish and implement the incoming inspection record system in accordance with these Regulations;

(3)    A supply enterprise wholesaling class II/III medical devices or retailing class III medical devices fails to establish and implement the sales record system;

(4)    An entity using medical devices fails to disinfect and manage reusable medical devices in accordance with relevant regulations;

(5)    An entity using medical device reuses single-use medical devices, or fails to destroy the single-use medical devices that have been used in accordance with relevant regulations;

(6)    As for the medical devices needing to be checked, inspected, calibrated and maintained periodically, the entity using these medical devices fails to check, inspect, calibrate and maintain these medical devices periodically in accordance with the requirements of Instructions for Use, make records accordingly, and make analysis and evaluation in time to ensure that medical devices are in good condition;

(7)    An entity using medical devices fails to properly keep the source information of the purchased class III medical devices, or fails to record the information of large-scale medical devices and implantable or invasive medical devices in relevant records such as medical records;

(8)    When any potential safety hazard is found in a medical device in use, the entity using the medical device fails to stop using the medical device immediately and inform the parties involved to perform troubleshooting, or the entity continues using the medical device that still fails to meet the safety criteria for use after the troubleshooting;

(9)    An entity using medical devices uses large-scale medical equipment illegally, which fails to guarantee medical quality and safety;

(10)             A medical device manufacturing enterprise, a medical device supply enterprise or an entity using medical devices fails to carry out medical device adverse event monitoring and report the adverse events according to relevant requirements, or fails to cooperate with the investigation of medical device adverse events carried out by the Centers for Medical Device Adverse Event Monitoring and the Food and Drug Administration authorities.

Article 69 Any clinical trial institution that fails to conduct medical device clinical trials in accordance with the requirements of these Regulations shall be ordered by the Food and Drug Administration authority at or above the county level to take corrective measures or immediately stop the clinical trials, and the trial institution involved can be imposed a fine of no more than ¥ 50,000. If serious consequences are caused, the directly responsible person(s)-in-charge and other directly responsible person(s) shall be demoted, dismissed from their posts, or expelled according to law. The trial institution involved shall not conduct clinical trials for relevant medical devices within five years.

In case that a medical device clinical trial institution issues false clinical trial reports, the Food and Drug Administration authority at or above the county level shall impose a fine of no less than ¥ 50,000 but no more than ¥ 100,000 on the medical device clinical trial institution involved. If there is illegal income, such illegal income shall be confiscated. The directly responsible person(s)-in-charge and other directly responsible person(s) shall be dismissed from their posts or expelled according to law. The trial institution involved shall not conduct clinical trials for relevant medical devices within 10 years.

Article 70 In case that a medical device testing institute issues false test reports, the corresponding qualification-awarding authority shall revoke the Qualification Certificate for Medical Device Testing and shall not accept the qualification authentication application of the institute involved within 10 years. The institute involved shall be imposed a fine of no less than ¥ 50,000 but no more than ¥ 100,000. If there is illegal income, such illegal income shall be confiscated. The directly responsible person(s)-in-charge and other directly responsible person(s) shall be dismissed from their posts or expelled according to law. Any person who is expelled shall not engage in medical device testing within 10 years from the date when such administrative sanction is made.

Article 71 In case that an advertisement publisher publishes an unapproved medical device advertisement, fails to verify the authenticity of the approval document in advance, or publishes a medical device advertisement whose content is not consistent with the approval document, the AIC authority shall impose penalties on the advertisement publisher involved in accordance with the relevant laws and administrative regulations on advertising management.

Where the approved advertisement contents are tampered with, the original approval authority shall revoke the corresponding Approval Document for Medical Device Advertisement and shall not accept the application for advertisement examination and approval submitted by the advertisement publisher involved within two years.

In case of any false medical device advertisement, the Food and Drug Administration authority at or above the provincial level shall decide to suspend the distribution of the medical devices involved and announce such decision to the public. If the medical devices involved are still distributed, the Food and Drug Administration authority at or above the county level shall confiscate the medical devices illegally distributed and the party involved shall be imposed a fine of no less than ¥ 20,000 but no more than ¥ 50,000.

Article 72 In case that the Centers for Medical Device Evaluation or Centers for Medical Device Adverse Event Monitoring fail to perform their duties in accordance with these Regulations, resulting in serious mistakes in technical review and monitoring, the Food and Drug Administration authorities at or above the county level shall order them to take corrective measures, circulate a notice of criticism and give a warning accordingly. If serious consequences are caused, the directly responsible person(s)-in-charge and other directly responsible person(s) shall be demoted, dismissed from their posts, or expelled according to law.

Article 73 The Food and Drug Administration authorities, the Health and Family Planning Commission authorities, and their staff shall exercise power of administrative penalty in strict accordance with the types and extent of administrative penalties prescribed in these Regulations, as well as based on the nature and concrete details of the illegal activities. The detailed provisions shall be formulated by CFDA and NHFPC on the basis of their respective duties.

Article 74 In case that the Food and Drug Administration authorities or other related authorities at or above the county level fail to fulfill their duties of supervision and administration of medical devices, or involve abusing authority, dereliction of duty and playing favoritism and committing irregularities, the supervisory authorities or the authorities in charge of appointment and removal shall give such sanctions as warning, demerit recording or serious demerit recording to the directly responsible person(s)-in-charge and other directly responsible person(s) according to law. If serious consequences are caused, the directly responsible person(s)-in-charge and other directly responsible person(s) shall be demoted, dismissed from their posts, or expelled.

Article 75 If the violation of the provisions of these Regulations constitutes a crime, the party involved shall be prosecuted for criminal liabilities according to law. If personal injuries, property damages or other damages are caused, the party involved shall be liable for compensation according to law.

 

Chapter VIII - Supplementary Provisions

Article 76 For the purpose of these Regulations, the following terms and definitions shall apply:

Medical device: any instrument, apparatus, implement, in vitro diagnostic (IVD) reagent and calibrator, material or other similar or related article, including software needed, intended to be used for human beings directly or indirectly, which does not achieve its primary intended action by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, for one or more of the specific purpose(s) of:

(1)    diagnosis, prevention, monitoring, treatment or alleviation of disease;

(2)    diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

(3)    investigation, replacement, modification, or support of the anatomy or of a physiological process;

(4)    supporting or sustaining life;

(5)    control of conception;

(6)    providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.

Entity using medical devices: any entity that provides other people with medical services or other technical services by using medical devices, including medical institutions that have acquired the Practicing License of Medical Institution, technical service institutions for family planning that have acquired the Practicing License of Technical Service Institution for Family Planning, as well as blood stations, plasma collection stations and institutions for adaption of rehabilitative and assistive devices that do not need to acquire the Practicing License of Medical Institution according to law.

Large-scale medical equipment: any device included in the Catalogue of Large-scale Medical Equipment, with complex technology, large capital investment, high operation cost, and great impact on medical expenses.

Article 77 The Food and Drug Administration authorities can charge for the registration of medical devices. The specific charging items and charging standards shall be formulated by the competent authorities of finance and price control under the State Council in accordance with the relevant provisions of the State.

Article 78 The Provisions on Non-Profit Contraceptive Devices and the Provisions on Medical Devices Developed by Medical Institutions for Dealing with Public Health Emergencies shall be formulated by CFDA jointly with NHFPC.

The Provisions on TCM Medical Devices shall be formulated by CFDA jointly with State Administration of Traditional Chinese Medicine of the People's Republic of China in accordance with these Regulations. The Catalogue of Rehabilitative and Assistive Devices and the Provisions on Rehabilitative and Assistive Devices shall be formulated by CFDA jointly with Ministry of Civil Affairs of the People's Republic of China in accordance with these Regulations.

Article 79 The supervision and administration of medical devices used for armed forces shall be organized and implemented by the competent authorities for military health in accordance with these Regulations and relevant regulations of the Army.

Article 80 These Regulations shall apply from June 1, 2014.


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