Cessation of import licenses for all foreign medical device

July 31, 2016

In Vietnam, on 15 May 2016, the Vietnamese Government issued Decree No. 36/2016/ND-CP on medical device management. The Decree took effect on 1 July 2016. According to the new Decree, foreign medical devices no longer require import licenses but must be registered with and obtain Marketing Authorization licenses or Declaration Certifications from competent authorities before being imported and circulated in Vietnam. The Decree set forth a transitional period of 6 months to 1 year for implementation.

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