Registration in Vietnam

CMC Medical Devices offers medical device registration in Vietnam

Registration in Vietnam

CMC Medical Devices offers medical device and IVD product registration in Vietnam, supporting your entry into the Vietnamese market with comprehensive regulatory assistance and efficient local representation.

Registration in Vietnam is mandatory to legally market medical devices and in vitro diagnostic products in the country, and requires submission of a complete dossier to the Vietnam Ministry of Health (MOH) as well as compliance with all local regulatory requirements.

CMC can assist you throughout the entire registration process, offering expert guidance and ensuring a smooth market entry into Vietnam.

  • We submit your registration dossier to the Vietnam MOH.
  • We can act as your local authorized representative in Vietnam if required.
  • We assist with labeling and documentation compliance tailored to Vietnamese regulatory expectations.
  • Application of FSC required for the registration.
  • We manage communications with local authorities and support post‑market activities and renewals.

Choose CMC to get your registrations in Vietnam

Complete the contact form and one of our consultants will contact you as soon as possible.