Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices
On August 1, 2022, the Vietnamese Ministry of Health issued Circular 05/2022/TT-BYT, regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices. This circular contains the following details:
A. Supplement the list of in vitro diagnostic medical device that is not subject to quality assessment by the competent authority of Vietnam.
In addition to the cases listed in Point dd Clause 3 Article 30 of Decree 98/2021/ND-CP, either of the following cases is also exempted from submitting the Quality Assessment Certificate issued by a competent Vietnamese agency:
- Has been granted a Certificate of Free Sale from one of the following countries or organizations:
- US Food and Drug Administration (FDA) – USA;
- Therapeutic Goods Administration (TGA) – Australia;
- Health Canada (Health Canada);
- Japan’s Ministry of Health, Labor and Welfare (MHL W);
- Japan Pharmaceuticals and Medical Devices Agency (PMDA);
- China’s National Medical Products Administration (NMPA);
- The Korean Ministry of Food and Drug Safety (Ministry of Food & Drug Safety – MFDS);
- EU Member States issued according to regulation 2017/746 issued on 5 April 2017 of the Council and the European Parliament on in vitro diagnostic medical devices (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices).
- Having been granted a free-sale registration number or a certificate of circulation registration, or licensed to import in the form of commerce in Vietnam, except for cases where it has been revoked.
- Not a calibrator reagent, in vitro control material.
B. Medical devices Class B, C, and D may be purchased as normal goods.
The medical devices listed below can be purchased as normal goods and do not require to declare the eligibility for a trading license. However, it still must meet the conditions on preservation, storage, and transportation as prescribed by the owner of the medical devices. Do take note that these medical devices still have to be registered for circulation according to regulations.
- Personal blood pressure monitor.
- Blood oxygen saturation (SpO2) meter using a finger clip battery.
- Children’s nasal aspirator.
- Electronic thermometer, infrared thermometer.
- Medical equipment used to measure personal blood sugar: blood glucose meter, blood collection pen, test strip, blood collection needle, standard solution, control solution
- Personalized medical bandages and gauze.
- Artificial tears are classified as medical devices.
- Contraceptive film (does not contain drugs).
- Vaginal lubricants are classified as medical devices.
- Hot and cold packs using electricity.
- Self-testing in vitro diagnostic medical equipment of class B.
- In vitro diagnostic medical device for self-testing for HIV, SARS-CoV-2.
C. List of medical devices that must be inspected for safety and technical features;
There are 6 medical devices included in this list as follows:
- Breathing machine.
- Anaesthetic breathing machine.
- Electric scalpel.
- Infant incubator.
- Hemodialysis machine.
D. List of medical devices requiring import license to clarify the provisions at point d, clause 2, Article 76 of Decree 98/2021/ND-CP.
Accordingly, medical devices not included in the 46 groups (except for chemicals, insecticidal and germicidal preparations used in household and medical fields with only one purpose of sterilizing medical devices) and have been classified as Class C and D medical devices as published on the Ministry of Health’s Portal may continue to be imported until December 31, 2022 without limits on quantities and confirmation from the Ministry of Health.
E. Circular 05/2022/TT-BYT completely replaces Circular 39/2016/TT-BYT
Circular 39/2016/TT-BYT is repealed and replaced by Circular 05/2022/TT-BYT which focuses on the guidelines of the Classification of Medical Devices. However, the rules of classification and grouping remain unchanged.
F. Existing circulars issued by the Ministry of Health related to the management of medical devices, which will expire and will become obsolete from January 1, 2022:
- Circular 46/2017/TT-BYT dated December 15, 2017 of the Minister of Health detailing the implementation of some articles of circular 36/2016/ND-CP dated May 15, 2016 of the Government on the management of medical devices;
- Circular 33/2020/TT-BYT dated December 31, 2020 of the Minister of Health provides for the list of the medical device subject to safety inspection and technical features;
- Clause 1, Article 1 of Circular 23/2021/TT-BYT dated December 9, 2021 of the Minister of Health amending and supplementing some legal documents promulgated by the Minister of Health.
Circular 05/2022/TT-BYT takes effect from the date of signing, 01 Aug 2022.
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