Council is to Advise on New License Issuance and Renewals

On November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to oversee the efficient and transparent implementation of new medical device rules. The council will be led by Dr. Le Quant Cuong, the former Deputy Minister of Health, and is tasked with overseeing new registrations of higher risk devices and the extension of existing medical equipment registrations. The council will have 17 members and is scheduled to begin work in May 2021.

The formation of the Council is seen as an important step to a smooth implementation of the new medical device regulations in Vietnam which are scheduled to come into effect on January 1, 2022.  Depending on the Council’s progress, there is potential that the MOH could release new guidance in Q2 of 2021 and begin issuing Class B, C, and D product licenses as early as Q3 or Q4 of 2021.

Current Requirements in Vietnam

Currently, the Vietnamese regulations are in transition from Circular 30 to Decree 36 with a full transition completed in 2022. Currently, only Class A products and specific Class B, C, and D, as designated in Circular 30, are required to have a Market Authorization license (MAH) to clear customs. Products not found on the Circular listing may now clear Customs and sold in Vietnam without an Import License until December 31, 2021. However, medical devices should have their products classification confirmed by a local, qualified classification agent to ensure expeditious customs clearance. From January 1, 2022, these devices will also require a Market Authorization License (under the new Rules).  Medical devices manufacturers should work with their local agents to determine the specific regulatory requirements for their portfolio now and after January 1, 2022.

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