Circular 05/2022/TT-BYT detailing Decree 98/2021/ND-CP on management of medical devices

CIRCULAR

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

Pursuant to the Government’s Decree No 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices;

At the request of the Director of the Department of Medical Equipment and Construction;

The Minister of Health promulgates the Circular 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.

Article 1. Scope of regulation

1. This Circular details a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices (hereinafter referred to as Decree No. 98/2021/ND-CP), including:

a) Classification of medical devices prescribed in Clause 5, Article 5 of Decree No. 98/2021/ND-CP;

b) The supplement of the list of in vitro diagnostic medical devices that is not subject to quality assessment by any competent agencies of Vietnam prescribed at Point dd, Clause 3, Article 30 of Decree No. 98/2021/ND-CP;

c) The list of medical devices of types B, C, D that can be traded like other normal goods prescribed in Clause 1, Article 42 of Decree No. 98/2021/ND-CP;

d) The list of medical devices subject to safe and technical inspection prescribed in Clause 10, Article 70 of Decree No. 98/2021/ND-CP;

dd) The list of medical devices being granted import licenses as prescribed at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP.

2. Announcing the invalidity of a number of legal documents on the management of medical devices.

Article 2. Regulations on classification of medical devices

1. Medical devices are classified according to one or a group to determine their levels of risk and issue registration numbers.

2. The classification of one or a group of medical devices must be based on their classified levels of risks A, B, C, D (specifically prescribed in Appendix I issued together with this Circular).

3. Classification results of medical devices shall be presented according to the form in Appendix II of this Circular.

Article 3. Supplementing the list of in vitro diagnostic medical devices that are not subject to quality assessment by any Vietnamese competent agencies prescribed at Point dd, Clause 3, Article 30 of Decree No. 98/2021/ND-CP

1. The in vitro diagnostic medical device has been granted a Certificate of Free Sale by one of the following countries or organizations:

a) U.S. Food and Drug Administration (FDA) – the USA;

b) Therapeutic Goods Administration (TGA) - Australia;

c) Health Canada;

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

dd) Pharmaceuticals and Medical Devices Agency of Japan (PMDA);

e) National Medical Products Administration of China (NMPA);

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

h) EU member states (granted according to the Regulation (EU) 2017/746 dated April 5, 2017 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices).

2. The in vitro diagnostic medical device has been granted the registration number or the Certificate of Registration, the import license in the commercial form in Vietnam, excluding cases that it has been revoked.

3. Not being in-vitro diagnostic reagents, calibrators and control materials

Article 4. The list of medical devices of types B, C, and D that can be traded as other normal goods as prescribed in Clause 1, Article 42 of Decree No. 98/2021/ND-CP

1. Personal blood pressure monitor.

2. Fingertip Pulse Oximeter, Blood Oxygen Saturation Monitor (SpO2).

3. Baby nasal aspirator.

4. Electronic thermometer, infrared thermometer.

5. Medical devices used to measure personal blood sugar: blood glucose meter, blood collecting pen, test strip, blood collecting needle, standard solution, control solution.

6. Nebulizer.

7. Medical bandage and gauze.

8. Artificial tears classified as medical devices.

9. Condom.

10. Contraceptive film (not containing drugs).

11. Vaginal lubricants classified as medical devices.

12. Electric hot and cold packs.

13. Self-testing in vitro diagnostic medical devices of type B.

14. Self-testing in vitro diagnostic medical devices for HIV, SARS-CoV-2.

Article 5. The list of medical devices subject to safe and technical inspection prescribed in Clause 10, Article 70 of Decree No. 98/2021/ND-CP

1. Ventilator.

2. Anaesthesia ventilator.

3. Electric scalpel.

4. Infant incubator.

5. Defibrillator.

6. Dialysis machine.

Article 6. The list of medical devices being granted import licenses as prescribed at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP

1. X-ray imaging devices.

2. Magnetic Resonance Imaging.

3. Diagnostic ultrasound machine.

4. Diagnostic endoscopy system.

5. Cyclotron system.

6. Radioisotope diagnostic equipment (PET, PET/CT, SPECT, SPECT/CT, devices for measuring iodine concentration I¹³⁰, I¹³¹).

7. Automatic cornea refractometer.

8. Electrophysiology machine (electroencephalogram machine, Electrocardiogram machine, electromyography machine).

9. Retinometer.

10. Bone densitometer.

11. Fundus tomography machine; Fundus fluoroscopy machine.

12. Ultrasound fetal heart rate monitor.

13. Respirometer.

14. Biochemistry analyzer; Arterial blood gas analyzer.

15. Hematology analyzer; Blood grouping analyzer.

16. Coagulation meter; Erythrocyte sedimentation rate meter.

17. ELISA test system.

18. Cell extractor.

19. Platelet function test analyzer.

20. Bacterial and virus identification machine.

21. Immunoassay machine.

22. In-vitro diagnostic reagents, calibrators and control materials

23. X-ray treatment devices.

24. Laparoscopic surgery system.

25. Radiotherapy devices (Cobalt machines, linear accelerators for cancer treatment, gamma scalpel of all kinds, brachytherapy devices of all kinds).

26. Patient monitor.

27. Infusion pump; Electric injection pump.

28. Scalpel (high-frequency electricity, laser, ultrasound).

29. Surgical microscope.

30. Prostate surgery devices system.

31. Artificial heart-lung machine.

32. Surgical positioning devices.

33. Cryosurgery devices.

34. Infant incubator; Infant warmer.

35. Anaesthetic machine/anesthetic machine with breathing system.

36. Ventilator.

37. Defibrillator, pacemaker.

38. High-pressure oxygen chamber.

39. Extracorporeal shock wave lithotripsy/ultrasonic lithotripsy system.

40. System of high-intensity ultrasound devices for tumor treatment.

41. Dialysis devices.

42. System of specialized ophthalmic surgery (Laser Excimer, Femtosecond Laser, Phaco, Vitreous cutter, Corneal flap cutter).

43. Eyeglasses, contact lenses (nearsightedness, farsightedness, astigmatism) and contact lens solution.

44. Ophthalmic laser machine.

45. Long-term medical implants (over 30 days).

46. Equipment and materials for intervention in the body of cardiology, cranial nerves.

Article 7. Effect

1. This Circular takes effect on August 1, 2022.

2. The contents detailing a number of articles of Decree No. 98/2021/ND-CP in this Circular shall be applied from the effective date of Decree No. 98/2021/ND-CP.

3. Forms No. 13.01, No. 13.02 prescribed in Appendix I and other forms prescribed in Appendix V of the Minister of Health’s Circular No. 19/2021/TT-BYT dated November 16, 2021, providing the forms of documents, reports on the implementation of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices shall cease to be effective from the date on which this Circular takes effect.

4. The following documents shall cease to be effective from January 1, 2022:

a) The Minister of Health’s Circular No. 39/2016/TT-BYT dated October 28, 2016, on classification of medical devices;

b) The Minister of Health’s Circular No. 46/2017/TT-BYT dated December 15, 2017, on guidelines for the Government's Decree No. 36/2016/ND-CP dated May 15, 2016, on the management of medical devices;

c) The Minister of Health’s Circular No. 33/2020/TT-BYT dated December 31, 2020, on promulgating the List of medical devices subject to safe and technical inspection;

d) Clause 1, Article 1 of the Minister of Health’s Circular No. 23/2021/TT-BYT dated December 9, 2021, amending and supplementing a number of legal documents issued by the Minister of Health.

Article 8. Implementation roadmap

1. For medical devices prescribed in Clauses 1, 2 and 3, Article 5 of this Circular:

a) If purchased after December 31, 2022, the safety and technical functions of the medical devices must be inspected in accordance with the inspection process issued by the Minister of Health;

b) If purchased before January 1, 2023, the inspection must be completed by June 1, 2023 in accordance with the inspection process issued by the Minister of Health.

2. For medical devices specified in Clauses 4, 5 and 6, Article 5 of this Circular:

a) If purchased after December 31, 2023, the safety and technical functions of the medical devices must be inspected in accordance with the inspection process issued by the Minister of Health;

b) If purchased before January 1, 2024, the inspection must be completed by June 1, 2024 in accordance with the inspection process issued by the Minister of Health.

Article 9. Organization of implementation

The Chief of the Ministry’s Office; the Chief Inspector of the Ministry; the Directors, Directors General of Departments and Administrations under the Ministry of Health; the Directors of Health Departments of provinces and centrally-run cities and related agencies, organizations and individuals shall take the responsibility for the implementation of this Circular.

Any difficulties arising in the course of implementation should be promptly reported to the Ministry of Health for consideration and handling./.

* All Appendices are not translated herein.