Medical device registration in Vietnam: According to the level of risk assessment, medical devices in Vietnam are divided into two categories and four grades, namely grade A (low risk), grade B (low average risk), grade C (high average risk) and grade D (high risk).
Import License: Most products in Vietnam do not require an import license, and only some products need to be licensed when imported. Under the original decree, most of the C and D products (such as ventilators, infant incubators, pacemakers, X-ray machines, MRIs, hemodialysis equipment, etc.) that generally require import authorization do not need to apply for marketing authorization after applying for import authorization. The new decree unifies import authorization and marketing authorization, i.e., only marketing authorization is required, and there is no need to apply for import authorization separately.
Reference country approval: Under the original decree, medical devices that hold marketing authorization approval for medical devices in any of the countries of the United States, Canada, Europe, Japan or Australia can be exempted from the technical review process when submitting for registration in Vietnam. The new decree adds China and South Korea as one of the aforementioned reference countries, and if a medical device has obtained a medical device registration certificate issued by the National Medical Products Administration of China, the fast-track review process can also be applied when it is registered and marketed in Vietnam, and the technical review is exempted.
Validity period of registration license: Under the original decree, the registration license of Class A products is valid forever, while the validity period of Class B, C and D products is five years, and the renewal procedures need to be completed one year before expiration. Under the new Act, all grades of registered products will be valid in perpetuity, unless such Act is changed.
Participating in Vietnam industry exhibitions is the best choice to quickly and efficiently expand the target market and get orders early!
2024 Vietnam Medical Aesthetic Industry and Health Care Equipment Exhibition 450 booths.
The 31st Vietnam International Medical Devices and Pharmaceutical Technology Exhibition 2024.
When: 05/09-12.
Venue: ICE International Convention and Exhibition Center, Hanoi.
2024 22nd Vietnam Ho Chi Minh International Medical Equipment, Hospital Equipment and Pharmaceutical Technology Exhibition 500 booths.
When: August 01-03.
Venue: Ho Chi Minh International Convention and Exhibition Center SECC
2024 19th Vietnam International Medical Devices & Health Care Products Exhibition 500 booths.
When: 09 months.
Venue: Ho Chi Minh International Convention and Exhibition Center SECC
350 booths at the 30th Vietnam Hanoi International Medical Device, Hospital Equipment and Pharmaceutical Technology Exhibition 2024.
When: December 05-07.
Venue: ICE International Convention and Exhibition Center, Hanoi.
Vietnam exhibition in China over the years
Guangxi Nanning China Expo Exhibition V+189-789-00092 Service *** Vietnam Expo Network vnexpoorg