Benefits of Medical Device Registration with Cekindo
Vietnamese Healthcare Landscape – What you need to know
With a population of more than 95 million and continuous economic growth, the standards of Vietnamese people are continually evolving, and the demand for health care and medical products does not always meet the current supply. Local companies are not able to manufacture advanced medical equipment, therefore the country relies heavily on foreign imported medical products.
In Vietnam, where medical devices and their related products have a profit margin of between 35 and 40 percent, the investment opportunities for foreign medical companies are hot.
Medical Device Registration Process in Vietnam
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 in Vietnam
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 as bandages or surgical gloves while Classes B, C and D include “higher-risk” or “more invasive products” such as artificial hearts or contact lenses.
Government Agency Responsible
The Ministry of Health’s Department of Medical Equipment and Health Works (DMEHW) is the regulatory organization that oversees the registration and licensing of all medical devices in Vietnam.
This agency acts as a branch of Vietnam’s Ministry of Health (MOH) which issued decrees 36 and 39 in 2016, directing that all device registrations be handled by the DMEHW, which operates under the jurisdiction of the MOH.
Rules & Regulations Regarding the Registration of Medical Devices
Clinical trials are required for medical devices that have never been imported into Vietnam and that provide a new feature or therapy. Foreign clinical studies are normally permitted; however, the DMEHW may seek local clinical trials conducted by the MOH in exceptional circumstances.
Class A Device
Regulations
A declaration of the appropriate standard dossier is required for Class A devices. The following documents are required:
- The form for applying
- Declaration of a class A application
- Table of medical equipment classifications
- Quality control standards certificate
- The owner of the medical equipment must sign a letter of authorization.
- Certificate of eligibility for warranty provision
- Conformity certificate
- The device’s written instructions
- Labeling on the device
- Free Sales Certificate
Class B Device
Regulations
A free sale registration dossier is required for Class B-D devices. The following documents are required:
- The form for applying
- Table of classifications
- Conformity certificate
- Certificate of eligibility for warranty provision
- Functions, specs, and other technical details for the device are described in this catalog.
- The device’s written instructions
- Free Sales Certificate
- Labeling on the device
- Medical equipment: a brief description (in Vietnamese)
- The device’s written instructions
- Any remarks made in a language other than English or Vietnamese must be translated into that language
Class C & D Device
Registration
- The form for applying
- Table of classifications
- Conformity certificate
- Certificate of eligibility for warranty provision
- Functions, specs, and other technical details for the device are described in this catalog
- The device’s written instructions
- Free Sales Certificate
- Labeling on the device
- Medical equipment: a brief description (in Vietnamese)
- The device’s written instructions
- Summary of clinical testing data for devices
- A certificate of inspection is required for IVDs
- Any remarks made in a language other than English or Vietnamese must be translated into that language
