Circular No. 33/2020/TT-BYT stipulates the list of medical devices that must be safety and technical performance tested, applicable to machines such as ventilators, anesthesia machines with ventilation, electro-surgical units, infant incubators, defibrillators, and dialysis machines.
适用范围
Ministry of Health, healthcare facilities, medical device testing institutions
要点
- Medical devices such as ventilators, anesthesia machines with ventilation, electro-surgical units, infant incubators, defibrillators, and dialysis machines must undergo safety and technical performance testing (Article 1).
- Medical devices purchased from September 1, 2021 onwards must be tested according to the procedures issued by the Minister of Health (Article 4.1.a).
- Medical devices purchased before September 1, 2021 must complete the testing process by December 31, 2022 (Article 4.1.b).
- Medical devices purchased from September 1, 2022 onwards must be tested according to the procedures issued by the Minister of Health (Article 4.2.a).
- Medical devices purchased before September 1, 2022 must complete the testing process by December 31, 2023 (Article 4.2.b).
🌐 本文件的社会影响
- Enhance the safety and quality of healthcare services for the people.
- Healthcare facilities must conduct medical device testing in accordance with the regulations, which imposes time and cost burdens.
- The Ministry of Health is responsible for reviewing and supplementing the list of medical devices requiring testing.
❓ 常见问题
Which types of medical devices must be tested?
Ventilators, anesthesia machines with ventilation, electro-surgical units, infant incubators, defibrillators, and dialysis machines.
When does the implementation of medical device testing begin?
Medical devices purchased from September 1, 2021 onwards must be tested immediately, while those purchased before this date need to complete the testing process within the specified deadlines.
Who is responsible for conducting the testing?
Healthcare facilities and medical device testing institutions.
全文
CIRCULAR
REGULATIONS ON THE LIST OF MEDICAL DEVICES THAT MUST BE SAFETY AND TECHNICAL FUNCTIONALITY INSPECTED
Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management;
Pursuant to Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing certain articles of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management;
At the proposal of the Director of the Department of Medical Equipment and Health Facilities,
The Minister of Health issues this Circular stipulating the list of medical devices that must be safety and technical functionality inspected.
Article 1. List of medical devices that must be safety and technical functionality inspected
1. Ventilators.
2. Anesthesia machines with ventilation.
3. Electric surgical knives.
4. Incubators for newborns.
5. Defibrillators.
6. Artificial kidneys.
Article 2. Effective Date
This Circular takes effect from March 1, 2021.
Article 3. Responsibilities for Implementation
1. The Ministry of Health shall be responsible for reviewing and supplementing the list of other Class B, C, and D medical devices that must be safety and technical functionality inspected according to the annual schedule.
2. Medical facilities shall be responsible for organizing the implementation of safety and technical functionality inspections of medical devices in accordance with the implementation timeline specified in Article 4 of this Circular.
3. Inspection organizations of medical devices shall be responsible for conducting safety and technical functionality inspections of medical devices in accordance with the inspection procedures issued by the Minister of Health.
Article 4. Implementation Timeline
1. For medical devices specified in Clauses 1, 2, and 3 of Article 1 of this Circular:
a) If purchased from September 1, 2021 onwards, they must undergo safety and technical functionality inspections in accordance with the inspection procedures issued by the Minister of Health.
b) If purchased before September 1, 2021, they must complete the inspections by December 31, 2022.
2. For medical devices specified in Clauses 4, 5, and 6 of Article 1 of this Circular:
a) If purchased from September 1, 2022 onwards, they must undergo safety and technical functionality inspections in accordance with the inspection procedures issued by the Minister of Health.
b) If purchased before September 1, 2022, they must complete the inspections by December 31, 2023. During the implementation process, if any issues arise or difficulties occur, organizations and individuals are advised to report them to the Ministry of Health for consideration and resolution.
DEPUTY MINISTER
原始文件（PDF）
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