ASEAN Medical Device Regulations

 

In August 2014, the Association of Southeast Asian Nations (ASEAN) signed a formal agreement that harmonized medical device regulations. This agreement was formally called the ASEAN Medical Device Directive (AMDD). It provides a straightforward path to the market for medical device manufacturers.

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An important element of the AMDD is the ASEAN Common Submission Dossier Template (CSDT). This a collection of information and requirements that allows a device manufacturer to provide different regulatory authorities with the same body of documentary evidence. Use of the CSDT helps to reduce costs for manufacturing companies seeking to obtain device approval in any of the 10 ASEAN countries.