Obtaining approval to sell medical devices in Vietnam just got harder – and more costly – for importers. Starting in January, all medical devices marketed in the country will require approval by Vietnamese authorities. Previously, some devices already approved by the European Union, Japan, Canada, Australia or the United States could be legally sold in Vietnam.
The new regulation is designed to limit the risks to consumers of the rapidly expanding medical device industry in Vietnam. Until 2017, only a small number of medical devices imported into the county required any registration at all.
The regulation, Decree No. 169/2018/ND-CP does provide a mechanism for faster registration and customs clearance for products registered in at least two of the above countries, as well as for products already for sale in Vietnam for at least three years that have not been flagged as potentially of questionable quality or unsafe. Such products will still require registration by Vietnamese authorities. But the waiting time to secure the registration is half that for other products – 30 days instead of 60 days.
Decree 169 also tightens the process for registering all medical devices in Vietnam. Under the new regulation, imported Class A devices will require a certificate of free sale (CFS).
Amendments to the registration of Class A medical devices already sold in the country are permitted under the new law. Permitted changes include the address or name of the product owner, manufacturer or license holder, warranty information and instructions for use, and product packaging for in vitro medical devices.
Beginning in July 2020, approval of Class B, C and D medical devices will also require the ASEAN Common Submission Dossier Template (CSDT).