Vietnam Market Access for Medical Device

REGULATORY AGENCY

• Ministry of Health (MOH)

REGULATIONS

• Medical equipment listed in Appendix 7 of MOH’s Circular No. 08/2006/TT-BYT require registration.
• Medical equipment which are not listed in Appendix 7 and are imported into Vietnam require an import permit issued by the MOH.
• Only Vietnamese companies are allowed to distribute medical devices in Vietnam.

GUIDELINES

• A Free Sale Certificate from the device’s country of origin is usually required for import.
• License application procedures require that a sample of any new equipment be brought into Vietnam for clinical testing* by medical or healthcare establishments.
• In the future, Vietnam will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD), an overall regulation that harmonises medical device regulations in ASEAN countries.

* Waivers may be available for equipment of a size and cost that would make it impractical to transport and install as a sample for testing.

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