Vietnam issues new guidelines on medical device regulation

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At the end of 2021, the government of Vietnam published Decree 98 on the management of medical devices (Decree No. 98/2021/ND-CP of Nov. 8, 2021), effective Jan. 1, 2022. This is the main medical device legislation in Vietnam. In order to provide the necessary guidance and clarification on the implementation of Decree 98, the Ministry of Health recently published Circular No. 05/2022/TT/BYT dated August 1, 2022 (“Circular 05”), which entered into force on the same day.

The most notable aspect of Circular 05 is that it unifies, in a single legislative document, the previous regulations on medical devices that were scattered in multiple circulars issued by the Ministry of Health (Circular No. 39/2016 /TT-BYT of October 28, 2016). 2106; Circular No. 46/2017/TT-BYT of December 15, 2017, as amended by Circular No. 23/2021/TT-BYT of December 9, 2021 and Circular No. 33/2020/TT-BYT of December 31, 2020 ). The effectiveness of these circulars ended when Circular 05 came into force.

Circular 05 sets out the rules and principles for classifying medical devices and adds or supplements the following lists:

  1. List of in vitro diagnostic (IVD) medical devices not subject to quality assessment by Vietnamese competent authorities upon registration under the rapid registration procedure.
  2. List of class B, C and D medical devices authorized to be marketed as normal goods.
  3. List of medical devices to be accredited for safety and technical functions before use.
  4. List of medical devices requiring import permit licenses.

Although Circular 05 does not introduce major changes from previous regulations, the consolidation and updated guidelines on Decree 98 will simplify the task of registration and circulation for medical device companies doing business in Vietnam.

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