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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See AllPursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the Government promulgated the Decree on amending, supplementing Articl
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The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the documents to be officialized. These will further amend the Dec
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Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Australia: Consultation
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