Decree No. 98/2021/NĐ-CP: Prescribing medical device management

On November 8, 2021, the Government issued Decree No. 98/2021/NĐ-CP Prescribing medical device management. This decree outlines the management of medical device, including:

  • The classification of medical device,
  • Production, clinical research, circulation, trading, export, import, and the provision of medical device services,
  • nformation and advertising related to medical device,
  • he management of the prices of medical device and the management and usage of medical device at healthcare facilities.

The validity of the circulation number for medical device is specified as follows:

– The circulation number of medical device is valid indefinitely, except in cases where the circulation number is issued in accordance with emergency regulations for medical device serving epidemic prevention, disaster relief, and mitigation.

– Based on the actual records of the medical  requesting emergency circulation, the Minister of Health decides the specific duration of the circulation number.

The enforcement of Decree No. 98/2021/NĐ-CP is valid from January 1, 2022, and it replaces Decree No. 36/2016/NĐ-CP dated May 15, 2016, Decree No. 169/2018/NĐ-CP dated December 31, 2018, and Decree No. 03/2020/NĐ-CP dated January 1, 2020

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