Yes, D-class medical device registration with the Vietnam Ministry of Health (MOH) does require ongoing compliance, and while the initial registration is typically valid for 5 years, there is an annual review process that manufacturers must adhere to. Here's an overview of the key points related to the annual review and ongoing compliance:

1. Validity of Registration

• The registration certificate for a D-class medical device issued by the Vietnam MOH is generally valid for 5 years.
• After the initial 5-year period, the registration will need to be renewed. This renewal process may involve a review of the device's safety, effectiveness, and any updates to regulations or standards.

2. Annual Review and Reporting Requirements

• Annual Reports: While there isn’t a specific annual renewal, manufacturers are typically required to submit annual reports to the Drug Administration of Vietnam (DAV). These reports include updates on:
  • Post-market surveillance data (including adverse events or recalls).
  • Changes to the product (e.g., changes in manufacturing, labeling, or intended use).
  • Any safety issues or complaints received in relation to the device.
• Safety and Performance Monitoring: Manufacturers must monitor the device's performance throughout its lifecycle. If any issues arise, they must report these to the MOH and take corrective actions when necessary.

3. Updating Regulatory Information

• If there are any modifications to the device (e.g., design changes, updates in materials, or manufacturing processes), the manufacturer must inform the Vietnam MOH. This is essential to ensure that the device continues to meet the country’s safety and quality standards.

• Renewal and Submission of New Documentation: During the renewal process or if there are substantial changes to the product, manufacturers may need to submit updated documentation, such as:

  • Clinical data or new test results.
  • Quality management system (QMS) updates.
  • Risk management updates or other relevant documents.

4. On-Site Inspections and Audits

• Periodic Inspections: In some cases, the Vietnam MOH may conduct periodic inspections of the manufacturing facility to ensure continued compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
• These inspections are more likely for high-risk devices, such as D-class devices, to verify that quality standards are being maintained over time.

5. Compliance with Changes in Regulations

• Vietnam’s medical device regulatory framework is subject to periodic changes. Manufacturers are required to keep up-to-date with these changes and ensure that their product remains compliant.
• The MOH may revise standards or introduce new regulatory requirements, and it is the manufacturer’s responsibility to ensure that their device complies with these updated rules.

Summary:

• Annual Review: D-class medical devices are subject to annual reporting requirements, including monitoring device safety and performance, but the registration certificate itself typically lasts for 5 years.
• Renewal: After 5 years, manufacturers will need to apply for renewal of the registration, which may involve submitting updated documentation and undergoing a review process.
• Ongoing Compliance: Manufacturers must ensure ongoing compliance by submitting regular reports, updating regulatory documents when necessary, and responding to any changes in regulations or safety concerns.

In essence, while there is not a formal annual renewal of the registration, there are ongoing annual reporting and compliance obligations for manufacturers of D-class medical devices.

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