Knowledge, Medical Devices

Decision on Classification of Medical Device

Regulations on the Classification of Medical Devices Currently

(In accordance with Article 2, Decision No. 05/2022/TT-BYT: Detailed regulations for implementing certain provisions of Decree No. 98/2021/ND-CP issued on November 8, 2021, by the Government on the Management of Medical Devices)

– Medical devices are classified individually or in groups to determine the level of risk and issue the circulation number.

– The classification of individual medical devices or groups must be based on the principles of risk classification A, B, C, D (Details can be found in Appendix I attached to Decision No. 05/2022/TT-BYT).

– The results of the classification of medical devices are reported using the form in Appendix II attached to Decision No. 05/2022/TT-BYT.

Supplementing the List of In Vitro Diagnostic Medical Devices Exempt from Quality Evaluation by the Authorized Department of Vietnam

(As specified in point d, Clause 3, Article 30 of Decree No. 98/2021/ND-CP on the Management of Medical Devices)

Medical devices that have been issued a CFS (Certificate of Free Sale) by one of the following countries or organizations:

a) Food and Drug Administration (FDA) – United States;

b) Therapeutic Goods Administration (TGA) – Australia;

c) Health Canada – Canada;

d) Ministry of Health, Labour, and Welfare (MHLW) – Japan;

e) Pharmaceuticals and Medical Devices Agency (PMDA) – Japan;

f) National Medical Products Administration – China;

g) Ministry of Food & Drug Safety (MFDS) – South Korea;

h) Member countries of the EU under Regulation 2017/746 issued on April 5, 2017, by the Council and the European Parliament on in vitro diagnostic medical devices.

2. Has been issued a circulation number or a Certificate of Registration for Circulation, or an import license for commercial purposes in Vietnam (except for cases of withdrawal).

3. Not a test drug, reference substance, in vitro control material.

List of Medical Devices of Class  B, C, D that Can be traded Like Regular Goods

  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 device, lancing device, test strip, lancet, control solution, calibrators.
  6. Nebulizers.
  7. Medical tape, gauze pads.
  8. Artificial tears classified as medical devices.
  9. Condoms.
  10. Vaginal contraceptive film (contains no drugs).
  11. Vaginal lubricants classified as medical devices.
  12. Electrical heating and cooling packs.
  13. Class B in vitro diagnostic (IVD) medical device for self-testing.
  14. In vitro diagnostic (IVD) medical device for self-testing of HIV, SARS-CoV-2.

List of Medical Devices that Must Be Tested for Safety and Technical Performance According to Regulations

  1. Ventilators.
  2. Anesthesia machines with ventilators.
  3. Electric surgical knives.
  4. Neonatal incubators.
  5. Defibrillators.
  6. Artificial kidney machines.

To receive advice on document services, procedural processes, and registration of medical device, customers can contact the Hotline at: 098.546.1894

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