Currently only some certain medical devices are registrable. From 1 July 2017, Class B, C, and D medical devices are required to be registered. There is also a need to have a marketing authorization license before a device can be imported and circulated in Vietnam. Currently, there are no official guidelines on classification of medical devices yet.
Pursuant 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
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
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Australia: Consultation
