Medical Device Registration in Vietnam

• The Ministry of Health (MOH) is in charge of executing legislative papers, strategies, guidelines, and blueprints concerning medical devices. Under the purview of the MOH, the Department of Medical Equipment and Construction (DMEC) is tasked with supervising the issuance of import licenses, registration numbers for medical devices categorized as Class B, C, and D, issuing Certificate of Free Sales, and validating advertising content.

Yes, all medical devices must be registered in Vietnam before they can be sold. Both imported and domestic devices must also be granted a marketing authorization (MA) license prior to being sold in Vietnam. MA licenses will need to replace all import licenses upon expiration of the import license.

• Medical devices are categorized into four types, namely classes A, B, C, and D, depending on the level of risk they pose. Class A devices are considered to have the lowest risk and encompass items like bandages, surgical gloves, and IV tubes. On the other hand, classes B, C, and D include higher-risk and/or more invasive products such as contact lenses and pregnancy test kits (class B), blood bags (class C), and artificial hearts (class D).The classification of the medical device is declared by the applicant during the registration process in Vietnam.

• After a product is determined to be Class A, a declaration of applicable standards should be submitted to local Department of Health. If approved, the Department of Health will issue a receipt note, and the Ministry of Health publish the device’s details online within 3 working days.

• After a product is determined to be Class B, C or D, an application for a free-sale registration number should be submitted to the Ministry of Health. If approved, the Ministry of Health will issue a receipt note, and publish the device’s details online within 3 working days.

Class A devices require a declaration of applicable standard dossier. The required documents include:

• The application form
• Class A application declaration
• Classification table of medical equipment
• Certificate of quality control standards
• Letter of authorization by the owner of the medical equipment
• Certificate of eligibility to provide warranty
• Certificate of conformity
• Written instructions for the device
• Device label
• Certificate of Free Sales

Any statements not in English or Vietnamese must be translated into the latter.

Class B-D devices require a free sale registration dossier. The required documents include:

• The application form
• Classification table
• Certificate of conformity
• Certificate of eligibility to provide warranty
• Catalog describing functions, specifications, and other technical information for device
• Written instructions for the device
• Certificate of Free Sales
• Device label
• Brief description of medical equipment (in Vietnamese)
• Written instructions for the device
• For class C or D devices, summary of clinical testing data
• For class C or D IVDs, certificate of inspection

Any statements not in English or Vietnamese must be translated into the latter.

No, local testing is not required for registration in Vietnam.

Medical device trials are conducted in three phases. Phases 1 and 2 must be completed before product registration, while phase 3 takes place after the medical devices are approved for circulation, as required by the authorities. These regulations are designed to ensure the ongoing assessment of the safety and effectiveness of medical devices once they are widely used in the community, aligning with their intended conditions of use.

When registering, it is generally mandatory to provide clinical data for the following:

1. Medical devices classified as Class B, C, and D.
2. In vitro medical devices categorized as reagents, calibrators, or control materials, irrespective of their classification.

Country of Origin approval, U.S. FDA approval, or a CE Mark certificate is required for registration in Vietnam.