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ao242 replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 5 months ago
The regulation of Medical Devices across the world is varies a lot, ranging from comprehensive to
none. Some countries have a developed structure for regulation of Medical Devices, while some are partially done and the rest are either in the process of developing a structure or do not yet have any regulation.
A country like Indonesia have a Medical Device directive that provides a more straightforward path to the market for medical device manufacturers. It was put together by Southwest Asian countries like Indonesia, China, Malaysia, Thailand etc. It is called ASEAN Medical Device Regulationshttp://agreement.asean.org/media/download/20141204115621.pdf
http://www.eibn.org/upload/EIBN_Indonesia_Medical_Device_regulation.pdf