The Circular No. 05/2022/TT-BYT detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices was issued on August 01, 2022, by the Ministry of Health. Accordingly, the Circular provides details in the following:
1. Regulations on classification of medical devices:
Risk classification of medical devices will follow the regulations of Appendix I of Circular 05/2022/TT-BYT. The Appendix I will replace Circular 39/2016/TT-BYT on risk classification of medical devices. However, the terms of risk classification are almost unchanged.
2. Supplement the list of in vitro diagnostic medical devices that are not subject to quality assessment by the competent authority of Vietnam, which include:
- Medical devices granted Free Sale Certificates from authorities of reference countries (USA, Australia, Canada, Japan, China, South Korea, EU)
- Medical devices acquired registration numbers, import licenses in the form of commercial in Vietnam, except for cases that have been withdrawn.
- Medical devices that are not reagents, calibrators, in vitro control materials.
3. Medical devices Class B, C, and D may be purchased as normal goods according to Article 42, Point 1 of Decree 98/2021/ND-CP, including:
1. Personal blood pressure monitors.
2. Fingertip pulse oximeter (SpO2).
3. Baby nasal aspirators.
4. Electronic thermometers, infrared thermometers.
5. Medical devices used to measure blood glucose: blood glucose monitoring devices, lancing devices, test strips, lancets, control solutions, calibrators.
7. Medical tape, gauze pads.
8. Artificial tears classified as medical devices.
10. Vaginal contraceptive film (without medicine).
11. Vaginal lubricants classified as medical devices.
12. Electric hot and cold packs
13. Class B IVD medical devices self-test
14. IVD medical devices self-test for HIV, SARS-CoV-2
4. Six medical devices subject to safe and technical inspection include: Ventilators; Anesthesia ventilators; Electric scalpels; Infant incubators; Defibrillators; Dialysis machines. These medical devices are the same as those listed in Circular 30/2020/TT-BYT.
5. List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
The list is identical to the one in Appendix I of Circular 30/2015/TT-BYT.
6. The Circular 05/2022/TT-BYT is effective from 2022/08/01 and the following regulations have expired
- Circular 39/2016/TT-BYT
- Circular 46/2017/TT-BYT
- Circular 33/2020/TT-BYT
- Article 1, Point 1 of Circular 23/2021/TT-BYT