REGULATORY UPDATE | VIETNAM ISSUES A CIRCULAR ON THE MANAGEMENT OF MEDICAL DEVICES

Vietnam's Ministry of Health issued Circular 05/2022/TT-BYT on August 1, 2022, which provides detailed guidance on how to implement a number of provisions of Decree 98/2021/ND-CP on Management of Medical Devices. Based on Government Decree No. 75/2017/ND-CP and No. 98/2021/ND-CP. The information in this circular is as follows:

Completing the list of in vitro diagnostic medical equipment is not subject to quality assessment by a competent Vietnamese institution specified in Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP 1. The Free Sales Certificate has been awarded by 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 pursuant to regulation 2017/746 issued on 5 April 2017 Council and European Parliament on in vitro diagnostic medical devices (Regulation (EU) 2017/746 European Parliament and Council 5 April 2017 on in vitro diagnostic medical devices vitro).

2. After issuance of circulation or circulation registration certificate or import permit in the form of trade in Vietnam, except for cases where it has been revoked. 3. Not a reagent, calibrator, in vitro control material.

The following list of medical devices can be purchased as ordinary commodities without disclosing eligibility for a trade license. However, they must comply with the standards of preservation, storage, and transit specified in the prescription of the owner of the medical device. Examples of such tools include:

• Personal blood pressure monitor.
• Blood oxygen saturation (SpO2) type meter with finger clip battery.
• Children's nasal suction machine.
• Electronic thermometer, infrared thermometer.
• Medical equipment used to measure personal blood glucose: blood glucose meter, blood collection pen, test strip, blood collection needle, standard solution, proof solution.
• Nebulizers.
• Bandages, personal medical gauze.
• Artificial tears are classified as medical devices.
• Condom.
• Contraceptive film (does not contain drugs).
• Vaginal lubrication solutions are classified as medical devices.
• Hot and cold packs use electricity.
• Peralatan medis untuk pengujian mandiri diagnostik in vitro kelas B.
• Medical equipment for in vitro self-test for HIV and SARS-CoV-2.

There are several medical devices that must be checked for safety and technicality in accordance with what is meant in Article 10 Article 70 of Presidential Regulation No. 98/2021/ND-Anesthesia machine with breathing.

• Electric scalpel.
• Ventilators.
• Anesthesia machine with breathing
• Infant incubator.
• Defibrillators.
• Hemodialysis machine.

Many medical devices are granted import permits to comply with the provisions of Point D Clause 2 Article 76 of Decree no. 98/2021/ND-CP, good medical device for Surgery, Diagnosis, dialysis and more

This Circular Letter shall come into force on August 1, 2022, upon the decision of the Ministry of Health of Vietnam.

Source: 05/2022/TT-BYT in Vietnam, Circular 05/2022/TT-BYT elaborating Decree 98/2021/ND-CP on management of medical devices in Vietnam (thuvienphapluat.vn)