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Other Asian countries

In addition to product registration in China, Europe and US, OSMUNDA Group also provides regulatory service ad guidance to other Asian countries, including Hongkong, Taiwan, Singapore, Japan, Malaysia, Korea, etc.

 

In August 2014, the Association of Southeast Asian Nations (ASEAN) signed a formal agreement, called the ASEAN Medical Device Directive (AMDD) which implies the motive to harmonize the medical device regulations, and to provide an uncomplicated path to the market for medical device manufacturers. The Common Submission Dossier Template (CSDT) is a collection of information and requirements that allows a medical device manufacturer to provide different regulatory authorities of the ASEAN member states with the same body of product registration documentations.

 

The ASEAN is comprised of 10 countries which include Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia.


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