The D-class medical device registration process with the Vietnam Ministry of Health (MOH) is detailed and thorough, as these devices are considered high-risk. The process includes several steps, required materials, and key considerations that must be addressed to ensure successful registration.

Process for D-Class Medical Device Registration

1. Appoint a Local Authorized Representative

   • Requirement: Foreign manufacturers must appoint a local authorized representative (usually a local distributor or regulatory consultant) to handle the registration process and communication with the Vietnam Ministry of Health (MOH).

2. Classify the Device

   • Requirement: Confirm that the device qualifies as D-class under Vietnam's medical device classification system. D-class devices are high-risk devices such as implantable devices, life-sustaining devices, and devices used in critical surgeries.
   • Importance: This classification will determine the level of regulatory scrutiny and requirements for the device.

3. Prepare the Registration Dossier

   • Documents Required: The manufacturer (through the local representative) must compile a detailed registration dossier that includes the following key materials:
     • Registration Application Form: A form provided by the Vietnam MOH, to be filled out with the product details.
     • Product Description: Detailed information about the medical device, including its intended use, function, and target market.
     • Manufacturing and Quality Control Information:
       • GMP (Good Manufacturing Practice) certificate from the manufacturing facility.
       • Evidence of ISO 13485 certification (Quality Management System for Medical Devices).
     • Clinical Data: For high-risk D-class devices, clinical trial data or post-market clinical follow-up data may be required to demonstrate safety and efficacy.
     • Risk Management Report: A report based on ISO 14971 that identifies and mitigates potential risks associated with the device.
     • Labeling: Product labeling and Instructions for Use (IFU) in Vietnamese or bilingual (Vietnamese and English).
     • Certificate of Free Sale (CFS): A certificate issued by the regulatory authority in the device’s country of origin confirming that the device is legally marketed there.
     • Declaration of Conformity: A statement from the manufacturer that the device complies with relevant international standards and regulations.
     • Post-Market Surveillance Plan: A plan detailing how the device will be monitored once it is in the market, including reporting of adverse events.

4. Submit the Dossier to the MOH

   • The local authorized representative submits the completed registration dossier to the Medical Device Administration (MDA) under the Vietnam Ministry of Health.
   • Online Submission: In some cases, the application can be submitted via the Vietnam MOH’s online portal. However, for high-risk D-class devices, submission may be done in person or through direct communication with the MDA.

5. MOH Review Process

   • The Vietnam MOH will review the submitted dossier. The review process includes:
     • Technical Evaluation: The MDA assesses the technical documentation, clinical data, and risk management report.
     • Inspection (if required): The MOH may require an inspection of the manufacturing facility to verify GMP compliance.
     • Additional Information: The MDA may request additional documents or clarifications during the review process.
     • Duration: This process typically takes 3 to 6 months for high-risk devices like D-class devices.

6. Issuance of Registration Certificate

   • After successful review, the Vietnam MOH will issue the Medical Device Registration Certificate.
   • Validity: The registration is valid for 5 years and can be renewed upon expiration.

7. Post-Market Surveillance and Reporting

   • After registration, the manufacturer must ensure the device's safety and effectiveness in the market. The local representative will be responsible for:
     • Post-market surveillance to monitor the performance of the device.
     • Reporting adverse events or any product defects to the Vietnam MOH.
     • Complying with renewal requirements before the expiration of the registration certificate.

Required Materials for D-Class Medical Device Registration

1. Registration Application Form: Completed form provided by the MOH.
2. Product Description: Detailed description of the device's intended use, technical specifications, and market history.
3. Good Manufacturing Practice (GMP) Certificate: To prove compliance with manufacturing quality standards.
4. ISO 13485 Certificate: Evidence that the manufacturer adheres to an international quality management system for medical devices.
5. Clinical Data: Clinical trial results or post-market surveillance data to support the safety and effectiveness of the device.
6. Risk Management Report: Based on ISO 14971 to identify and mitigate any potential risks associated with the device.
7. Certificate of Free Sale (CFS): Proving that the device is legally available for sale in the country of manufacture.
8. Labeling and Instructions for Use (IFU): Labels and user instructions in Vietnamese or bilingual (Vietnamese and English).
9. Declaration of Conformity: Manufacturer’s statement asserting compliance with applicable international standards.
10. Post-Market Surveillance Plan: A plan outlining how the manufacturer will monitor the device after it is marketed.

Key Considerations for D-Class Medical Device Registration in Vietnam

1. Compliance with International Standards: D-class devices must comply with international safety, quality, and performance standards, such as ISO 13485 for quality management and ISO 14971 for risk management.

2. Clinical Data: D-class devices typically require clinical data to support their safety and efficacy. The clinical trials must adhere to internationally accepted guidelines and should be robust enough to meet Vietnam's regulatory requirements.

3. Local Language Requirements: All documents submitted to the Vietnam MOH, including labeling and instructions for use (IFU), must be in Vietnamese or bilingual (Vietnamese and English). Translations should be accurate and legally compliant.

4. Post-Market Surveillance: Vietnam places a significant emphasis on post-market surveillance to monitor the safety and performance of D-class devices once they are sold in the market. Manufacturers must ensure robust systems are in place for reporting adverse events and addressing safety concerns.

5. Authorized Representative: As a foreign manufacturer, you must work with a local authorized representative to handle the registration process, submit documents, and manage communications with the Vietnam MOH. The local representative ensures the device complies with Vietnamese regulatory requirements.

6. Time and Cost: The registration process for D-class medical devices in Vietnam is time-consuming and can take anywhere from 6 to 12 months. The costs involved can range from USD 5,000 to USD 15,000 or more, depending on the device’s complexity, clinical data requirements, and whether clinical trials are needed.

Conclusion

The registration process for D-class medical devices with the Vietnam Ministry of Health involves a comprehensive approach, including technical documentation, clinical data, and post-market surveillance plans. D-class devices are subject to rigorous review due to their high-risk classification, and the process can take several months. Working with a local authorized representative is critical to navigating the regulatory landscape and ensuring compliance with Vietnam’s requirements.

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