Regarding periodic renewal of Class B medical device registration under the Hong Kong MDACS, here is what you need to know about standards and procedures:

Standards and Procedures for Periodic Renewal of Class B Medical Device Registration under Hong Kong MDACS

1. Renewal Requirement

• Currently, the Hong Kong Medical Device Administrative Control System (MDACS) does not require mandatory periodic renewal of registration for Class B medical devices.

• Once registered, the device remains listed as long as the information is kept up to date and the device complies with relevant regulations.

2. Ongoing Compliance Obligations

• Although formal renewal is not mandatory, the manufacturer or Local Responsible Person (LRP) must:

  • Keep registration information accurate and notify the Medical Device Division (MDD) of any changes.

  • Continue to comply with post-market surveillance and reporting requirements.

  • Maintain compliance with labeling, advertising, and quality standards.

3. When Renewal or Re-Submission May Be Required

• Renewal or re-submission might be requested if:

  • There are significant changes to the device or its intended use.

  • The Medical Device Division issues a directive due to regulatory updates.

  • The manufacturer voluntarily withdraws and reapplies.

4. Procedure if Renewal Is Required

If at any time the MDD requires renewal or re-certification, the typical procedure would involve:

• Submission of updated documentation, including:

  • Updated technical files

  • Post-market surveillance reports

  • Updated labeling and packaging information

• Payment of applicable fees

• Review and approval by MDD

• Issuance of renewed registration confirmation

5. Recommendations

• Stay informed on any regulatory changes announced by the Hong Kong Department of Health.

• Maintain organized records and documentation to facilitate quick response if renewal or additional information is requested.

• Regularly engage with the Local Responsible Person to ensure compliance.

Summary Table

If you want, I can help you monitor regulatory updates or draft a compliance calendar to manage ongoing obligations for your registered devices. Would you like that?

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