In response to the complicated stage of the COVID-19 pandemic in Vietnam, Ministry of Health has published a regulation, released as Circular 13/2021/TT-BYT17, on Approval and Import of Medical Devices for COVID-19 prevention in case of emergency.
17 categories of COVID-19-related medical devices that shall follow the required dossier and procedure shown in this regulation include:
Along with the list, MOH has also issued a total of 7 cases that can apply for fast approval as follows:
- Has been approved for emergency use or circulation by one of the following organizations: US Food and Drug Administration (FDA) - USA; Department of Therapeutic Goods Administration (TGA) - Australia; Health Canada (Canada); Ministry of Health, Labor and Welfare of Japan (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) – Japan
- Has been approved for emergency use or circulation by competent authorities of EU countries.
- Has been listed as SARS-CoV-2 testing product for emergency use by the World Health Organization (WHO) on its website at https://extranet.who.int (Coronavirus disease (COVID-19) Pandemic Emergency Use Listing Procedure (EUL) open for IVDs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control).
- Has been listed as SARS-CoV-2 testing product for emergency use by the European Health Security Committee (EUHSC) published on the website at https://ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu)
- Has been granted a import license for commercial purpose in Vietnam before the effective date of this Circular
- Has been domestically manufactured in form of technology transfer of medical devices falling into one of the first five cases above.
- Has been domestically manufactured in form of outsourcing of medical devices falling into one of the first five cases above.
Submission dossier shall comply with current regulation (Decree36/2016 & 169/2018) together with additionally selective documents depending on each case. Documents that are issued by foreign countries must be legalized. Original LOA can be submitted without legalization. For documents that grant the medical device the approval, without legalization, a corresponding link to look up the approval is mandatory. Hard copy shall be submitted to Department of Medical Equipment and Construction.
Medical device Class B applies for a Declaration of Applicable Standard while medical device Class C, D applies for a Certificate of Free sale Registration. Declaration of Applicable Standard is a three-day procedure. For Certificate of Free sale Registration, dossier is reviewed within 10 days and a complete dossier can obtain a certification in the following three days. Fee remains unchanged.
This Circular is implemented immediately and the approval is valid until December 31st,2022.
Circular 13/2021/TT-BYT Regulation on Approval and Import of Medical Devices for COVID-19 prevention in case of emergency