Medical Device Registration in Vietnam

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 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?

  • Previously, the registration of domestic devices and imported devices were handled by separate regulatory bodies. As of July 1, 2016 the Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), is the regulatory body that governs the registration and approval of all medical devices in Vietnam. In 2016, the MOH released decrees 36 and 39 dictating that the DMEHW would be in charge of all device registrations.

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 in Vietnam are classified into 4 risk categories:Class A: lowest risk

    Class B: low risk

    Class C: high risk

    Class D: highest risk

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 devices that have not previously been imported to Vietnam, which also incorporate a new functionality or therapy, require clinical trials. Foreign clinical trials are generally accepted; however, in certain cases the DMEHW may request MOH-conducted local clinical trials.

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 experts.

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