Thông tư 33/2020/TT-BYT trang thiết bị y tế phải kiểm định an toàn và tính năng kỹ thuật

CIRCULAR

Promulgating the List of medical devices subject to safe and technical inspection

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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. 36/2016/ND-CP dated May 15, 2016, on medical equipment management;

Pursuant to the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018, on amending and supplementing a number of articles of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, on medical equipment management;

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

The Minister of Health hereby issues the Circular on promulgating the List of medical devices subject to safe and technical inspection.

Article 1. The List of medical devices subject to safe and technical inspection

1. Ventilator.

2. Anaesthesia ventilator.

3. Electric scalpel.

4. Infant incubator.

5. Defibrillator.

6. Dialysis machine.

Article 2. Effect

This Circular takes effect on March 01, 2021.

Article 3. Implementation responsibilities

1. The Ministry of Health shall be responsible for reviewing and supplementing the List of medical devices types B, C or D subject to annual safe and technical inspection.

2. Medical establishments shall be responsible for organizing and implementing the safe and technical inspection for medical devices according to the roadmap specified in Article 4 of this Circular.

3. Medical device-testing establishments shall be responsible for carrying out the safe and technical inspection for medical devices in accordance with the inspection procedures promulgated by the Minister of Health.

Article 4. Roadmap for implementation

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

a) If such devices are purchased from September 01, 2021, they must be inspected for safety and technical specifications in accordance with the inspection procedures promulgated by the Minister of Health.

b) If such devices are purchased before September 01, 2021, the inspection must be finished before December 31, 2022.

2. For medical devices specified in Clauses 4, 5 and 6, Article 1 of this Circular:

a) If such devices are purchased from September 01, 2022, they must be inspected for safety and technical specifications in accordance with the inspection procedures promulgated by the Minister of Health.

b) If such devices are purchased before September 01, 2022, the inspection must be finished before December 31, 2023.

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