Medical Device Registration in Vietnam

Utilize our intimate industry knowledge and expertise to obtain Vietnam Ministry of Health registration approval for your medical device.

Contact us today for a consultation with our Vietnam medical device regulatory consultants.

Medical Device Registration in VietnamVietnam’s economy has been rapidly emerging over the last few years, and the medical device market is one of the many beneficiaries of this growth. About 70% of medical device purchases made in Vietnam — measured in terms of value — go to public hospitals. Due to Vietnam’s ease of market access and less regulation on imported devices, enormous opportunities exist for foreign companies aiming to grow their revenue.

The international medical device specialists at Pacific Bridge Medical have extensive experience with Vietnam’s medical regulations and can help you register and obtain approval for your product.

Click on the following questions to read more details about medical device registration and approval in Vietnam.

Which regulatory bodies in the Vietnamese government are responsible for 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.

In Vietnam, are medical devices required to be registered before they can be sold?

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.

What are the different regulatory classifications for medical devices?

  • 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.

What does the registration pathway look like for Class A medical devices 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.

What does the registration pathway look like for Class B-D medical devices in Vietnam?

  • 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.

What are the document requirements for Class A device registration in Vietnam?

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.

What are the document requirements for Class B-D device registration in Vietnam?

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.

Is local testing (type testing/sample testing) required for registration?

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

When are clinical studies required for registration?

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.

Is approval in the Country of Origin required for registration?

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

Contact us today for a consultation with our Vietnam medical device regulatory consultants.

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