To register a D-class medical device with the Vietnam Ministry of Health (MOH), you need to follow a detailed and regulated process due to the high-risk nature of D-class devices. Below is a step-by-step guide on how to apply for D-class medical device registration with the Vietnam MOH.

Step 1: Determine Device Classification

• Confirm Classification: Ensure that your device qualifies as a D-class medical device under the Vietnam regulations. D-class devices are typically high-risk devices, often used for critical purposes, such as implantable devices, life-support devices, etc.
• Classifications: The Vietnam MOH classifies medical devices into 4 categories (Class A to Class D), and the classification depends on the device's intended use and potential risk to patients. D-class devices are subject to the most stringent requirements.

Step 2: Appoint a Local Authorized Representative (if applicable)

• If you are a foreign manufacturer, you must appoint a local authorized representative in Vietnam who will act as the point of contact for the registration process.
• The authorized representative will handle the submission, communication with the Vietnam MOH, and ensure that the registration complies with Vietnamese regulations.

Step 3: Prepare Required Documentation

The application for D-class medical device registration requires extensive documentation. The required documents include:

1. Application Form: A completed application form with basic information about the manufacturer and the medical device.
2. Device Description and Classification: A detailed description of the device, including its intended use, classification rationale, and risk level.
3. Clinical Evaluation Report (CER): For D-class devices, you need to provide clinical data that demonstrates the device’s safety and efficacy. This includes clinical trial results or evaluation reports.
4. Risk Management File: A document that describes the risk management process for the device, following ISO 14971 or equivalent standards.
5. Quality Management System (QMS) Certification: Evidence of the manufacturer’s compliance with ISO 13485 or equivalent, ensuring the device is produced under good manufacturing practices (GMP).
6. Test Reports and Safety Data: Provide performance test reports, biocompatibility data, and other relevant safety information.
7. Certificate of Free Sale (CFS): If applicable, submit a CFS or similar document from the device's country of origin, confirming that it is legally sold there.
8. Labeling and Instructions for Use (IFU): Include the device’s labels, packaging, and instructions for use that comply with Vietnam’s regulations.

Step 4: Submit the Application

• Submission: Submit your completed application and all required documents to the Drug Administration of Vietnam (DAV), the relevant body under the Ministry of Health.
• Submission Process: The submission process can be done online via the MOH’s e-portal or directly at the DAV office, depending on the specific regulations in place at the time.
• Pay the Registration Fee: Pay the required registration fee as part of the application submission. The fee will vary depending on the device and its classification.

Step 5: Review and Evaluation by Vietnam MOH

After submission, the Vietnam MOH will conduct a thorough review of your application:

• Document Review: The MOH will evaluate the completeness of the documentation, ensuring that all required data is provided.
• Technical Review: A detailed review of the technical aspects of the device, including clinical data, risk management, and safety testing, will be conducted.
• On-site Inspection (if required): For D-class devices, an on-site inspection of the manufacturing facility may be required to verify compliance with Good Manufacturing Practices (GMP).
• Request for Additional Information: If there are any issues or missing information, the MOH may request additional documentation or clarification.

Step 6: Decision and Approval

• Approval: If your application meets all regulatory requirements, the MOH will issue a registration certificate for the device, allowing it to be marketed and sold in Vietnam.
• Rejection: If the application does not meet the necessary requirements, the MOH will provide feedback on why the registration was denied, and you may need to submit additional information or revise your application.

Step 7: Post-Market Surveillance

After the device is registered and approved, you are responsible for ongoing post-market obligations:

• Adverse Event Reporting: You must monitor the device’s safety and report any adverse events or safety concerns to the Vietnam MOH.
• Post-Market Surveillance: You are required to implement a system for tracking the device’s performance in the market.
• Registration Renewal: The registration for D-class devices is valid for a specific period (usually 5 years). Before it expires, you need to apply for registration renewal to continue selling the device in Vietnam.

Summary of the Application Process:

1. Classify the Device: Confirm that your device qualifies as D-class under Vietnam regulations.
2. Appoint a Local Representative (if foreign): A local authorized representative in Vietnam is required to handle the process.
3. Prepare the Documents: Compile the necessary documents, including clinical data, risk management files, and quality certifications.
4. Submit the Application: Submit the application and pay the registration fee to the DAV.
5. MOH Review: The MOH reviews your application, which may include an on-site inspection of the manufacturing facility.
6. Approval or Feedback: Receive the approval certificate or feedback on why the application was rejected.
7. Post-Market Obligations: Implement post-market surveillance and report any adverse events.

By following these steps, you can successfully apply for D-class medical device registration with the Vietnam Ministry of Health (MOH). Make sure to stay updated with any changes in regulations and guidelines to ensure smooth registration and market entry.

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