For D-class medical device registration in Vietnam, the application must be submitted to the Vietnam Ministry of Health (MOH), specifically to the Medical Device Administration (MDA), which is the regulatory authority responsible for overseeing the registration and regulation of medical devices in the country.

Where to Apply:

• Medical Device Administration (MDA)
  • The MDA operates under the Vietnam Ministry of Health and is the body responsible for reviewing and approving medical device registrations.
  • Location: The MDA is based in Hanoi, Vietnam. However, the registration can be managed remotely through their online system or through an appointed local authorized representative.

Steps to Submit the Application:

1. Preparation: Complete the necessary documentation, including the registration application form, technical dossier, and other supporting documents (e.g., certificate of free sale, GMP certification, clinical data, etc.).

2. Submission:

   • The local authorized representative (or importer) is responsible for submitting the complete registration dossier to the MDA. They will typically handle the application process on behalf of the manufacturer.
   • The application can be submitted through the MDA’s online registration portal or directly in person at the MDA office.

3. Online Submission (if applicable):

   • The Vietnam MOH has been gradually introducing online registration systems for medical devices. This may allow for online submission of the registration documents and tracking of the status of the application.
   • However, for D-class medical devices (high-risk), it is essential to confirm the specific submission requirements with the MDA, as the process for these devices might differ slightly.

4. Payment of Fees:

   • As part of the application process, the manufacturer or the local representative must pay the required registration fees to the MOH. This can usually be done through bank transfer or online payment, depending on the MOH's preferred method.

Contact Information for the Medical Device Administration (MDA):

• Address:

  • Ministry of Health (MOH), Vietnam
  • Medical Device Administration (MDA)
  • Address: No. 138A Giang Vo Street, Ba Dinh District, Hanoi, Vietnam

• Phone: Contact the MDA or your local representative for the most current phone number and operational hours.

• Email/Website: For further inquiries, visit the official website of the Vietnam Ministry of Health or contact the MDA directly.

Conclusion:

To apply for D-class medical device registration in Vietnam, the application should be submitted to the Medical Device Administration (MDA) under the Vietnam Ministry of Health. It is recommended to work with a local authorized representative who is familiar with the regulatory process and can submit the required documentation on your behalf.

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