Regulatory Update: Vietnam Issues a Circular on the Management of Medical Devices

On August 1, 2022, Vietnam's Ministry of Health issued Circular 05/2022/TT-BYT, providing detailed guidance for implementing several provisions of Decree 98/2021/ND-CP concerning the management of medical devices. This circular is based on Government Decree No. 75/2017/ND-CP and No. 98/2021/ND-CP, and it outlines specific regulations as follows:

1. In Vitro Diagnostic Medical Equipment:The list of in vitro diagnostic medical devices that are exempt from quality assessment by a competent Vietnamese institution is specified in Point dd Clause 3, Article 30 of Decree No. 98/2021/ND-CP. The following conditions apply:
   • A Free Sales Certificate must be obtained from one of the following authorities:
     • U.S. Food and Drug Administration (FDA) – USA
     • Therapeutic Goods Administration (TGA) – Australia
     • Health Canada
     • Japan’s Ministry of Health, Labor and Welfare (MHLW)
     • Japan Pharmaceuticals and Medical Devices Agency (PMDA)
     • China’s National Medical Products Administration (NMPA)
     • Korean Ministry of Food and Drug Safety (MFDS)
     • EU Member States, in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices, issued on April 5, 2017.
       
   • The device must have a circulation registration certificate or import permit in Vietnam, unless revoked.
   • The device must not be a reagent, calibrator, or in vitro control material.
     
2. Ordinary Commodities:Certain medical devices can be purchased as ordinary commodities without requiring a trade license, provided they meet the standards for preservation, storage, and transit as specified by the device owner. Examples include:
   • Personal blood pressure monitors
   • Blood oxygen saturation (SpO2) meters with finger clips
   • Children's nasal suction machines
   • Electronic and infrared thermometers
   • Personal blood glucose measurement devices (e.g., blood glucose meters, collection pens, test strips)
   • Nebulizers
   • Bandages and personal medical gauze
   • Artificial tears classified as medical devices
   • Condoms and contraceptive films (without drugs)
   • Vaginal lubrication solutions classified as medical devices
   • Electric hot and cold packs
   • In vitro self-test diagnostic equipment classified as Class B
   • Medical equipment for in vitro self-testing for HIV and SARS-CoV-2
     
3. Safety and Technical Checks: Several medical devices must undergo safety and technical assessments in accordance with Article 10, Article 70 of Presidential Regulation No. 98/2021/ND-CP, including:
   • Anesthesia machines with breathing apparatus
   • Electric scalpels
   • Ventilators
   • Infant incubators
   • Defibrillators
   • Hemodialysis machines

Moreover, many medical devices are granted import permits in compliance with Point D Clause 2 Article 76 of Decree No. 98/2021/ND-CP for surgical, diagnostic, dialysis, and other medical applications.

This Circular will come into force on August 1, 2022, following 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)