Thông tư 33/2020/TT-BYT quy định về danh mục trang thiết bị y tế phải kiểm định an toàn và tính năng kỹ thuật do Bộ Y tế ban hành

CIRCULAR

LIST OF MEDICAL DEVICES SUBJECT TO MANDATORY SAFETY AND TECHNICAL INSPECTION

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

Pursuant to Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on management of medical devices;

Pursuant to Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on amendments to Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on management of medical devices;

At request of Director General of Medical Equipment and Construction Department,

Minister of Health promulgates Circular on list of medical devices subject to mandatory safety and technical inspection.

Article 1. List of medical devices subject to mandatory safety and technical inspection

1. Breathing machine.

2. Anaesthetic breathing machine.

3. Electric scalpel.

4. Infant incubator.

5. Defibrillator.

6. Hemodialysis machine.

Article 2. Entry into force

This Circular comes into force from January 3, 2021.

Article 3. Responsibilities

1. Ministry of Health is responsible for reviewing and amending list of other type B, C and D medical devices subject to mandatory safety and technical inspection on an annual basis.

2. Medical facilities are responsible for organizing safety and technical inspection of medical devices according to roadmap for implementation specified under Article 4 of this Circular.

3. Medical device inspecting facilities are responsible for conducting safety and technical inspection for medical devices satisfactory to regulations prescribed by Minister of Health.

Article 4. Roadmap for implementation

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

a) In case medical devices are procured from September 1, 2021, conduct safety and technical inspection as prescribed by Minister of Health.

b) In case medical devices are procured before September 1, 2021, conduct inspection before December 31, 2022.

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

a) In case medical devices are procured from September 1, 2022, conduct safety and technical inspection as prescribed by Minister of Health.

b) In case medical devices are procured before September 1, 2022, conduct inspection before December 31, 2023.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration.

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