Vietnam eases medical device approval law, allowing longer transition period

One year after Vietnam first decreed that all medical devices and IVDs offered for sale in the country be approved by Vietnamese authorities by the end of 2020, the government is tweaking its law to permit Class B devices issued licenses to continue to be sold legally until the end of 2021. The date for Class C and D devices will be extended until the end of 2022. The transition to new registration requirements has proven cumbersome for some medical device manufacturers and the Vietnamese Health Authorities. Until 2017, only a small number of medical devices imported into the country required any registration at all.