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thuytienlecao replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 5 months ago
To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical devices manufactured in Vietnam and the other for imported ones. All domestically manufactured medical devices had to be registered and granted marketing authorization licenses from the Department of Medical Equipment and Health Works under the Ministry of Health before being circulated. These regulations are in accordance with the ASEAN Medical Device Regulations that has been mentioned in the previous post. The Foreign medical device did not require registration but had to obtain import licenses from the DMEHW to be imported and circulated in Vietnam. However, as of 2017, all imported medical devices are required to be registered for marketing authorization licenses.