With an increasing focus on developing the healthcare sector, the Vietnamese government is keen to make improvements to the medical device industry as it recognises the potential benefit for the healthcare system and its contribution to economic development. On 31 March 2021, the Vietnamese Ministry of Health published new draft regulations on medical device management which amongst other things, expands the scope of devices eligible for fast-track approval in the country. Medical devices management is currently regulated by a number of decrees, including Decree No 36/2016/ND-CP. In addition to supplementing the existing regulations on clinical trials involving medical devices, it is hoped the proposed regulations will unify and streamline the regulatory landscape governing the management of medical devices in the country.
The draft regulations released as Official Dispatch No 2271/BYT-TB-CT, which is under consideration by the government, specifies the phases of clinical trials required to be carried out before a medical device can be registered and circulated. Furthermore, the draft regulations include provisions on the obligations of involved entities and presents the processes to register and approve clinical trials protocols and results.
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