How to Register Medical Devices in Vietnam
All medical devices that enter the Vietnamese market must be registered prior to their distribution in Vietnam. The registration is governed and approved by the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health (MOH).
Importantly, both domestic and imported medical equipment must obtain a Marketing Authorization (MA) License and other administrative documents such as Good Manufacturing Practice (GMP) or a Certificate of Pharmaceutical Products (CPP).
The process of medical devices registration differs based on classification they belong to. While Class A medical devices require a declaration of an applicable standard dossier, the Class B-D devices require a free sale registration dossier (CFS).
Medical device classification
The classification of medical devices in Vietnam is now based on a risk classification (group A, B, C and D) as opposed to the former division based on function classes.
- Class A – lowest risk
- Class B – low risk
- Class C – high risk
- Class D – highest risk
Medical instruments that belong to Class A are considered “lowest risk” such bandages or surgical gloves while Classes B, C and D include “higher-risk” or “more invasive products” such as artificial hearts or contact lenses.
Medical Devices Registration with Cekindo
Cekindo provides one-stop market entry services in South East Asia. Our experienced team of lawyers and business consultants is not only able to register your medical devices products in Vietnam, but also establish a representative office (RO) needed for foreign traders.
Contact us today and get a free quotation on medical devices registration in Vietnam.