With a population of more than 95 million and continuous economic growth, standards of Vietnamese people are continually improving, and the demand for health care and medical products is getting higher and higher.
Medical supplies in Vietnam are in a shortage condition, and many hospitals are in need to upgrade their existing instruments. However, local companies are not able to manufacture advanced medical equipment, and the country relies heavily on foreign investors.
In Vietnam, where medical devices and their related products have a profit margin of between 35 and 40 percent, it became a big gold mine to register and distribute medical equipment.
How to a Register Medical Device 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 Health Service Department for class A devices and the Ministry of Health (MOH) for class B, C and D devices.
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).
All classes of medical 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 Device Registration in Vietnam 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 device registration in Vietnam.
