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For Class B medical devices registered under MDACS in Hong Kong, there isn’t a formal periodic renewal requirement like some other regulatory systems. However, there are important standards and procedural expectations for keeping your registration up-to-date. Here’s a detailed overview:
Standards & Procedures for Periodic Updates of Class B MDACS Registration
1. No Mandatory Periodic Renewal
Once registered, the listing remains valid indefinitely unless voluntarily delisted or suspended.
There is no fixed expiry or mandatory renewal date under MDACS.
2. Ongoing Update Obligations
Though no formal renewal, you must periodically maintain the accuracy and currency of your registration by notifying the Medical Device Division (MDD) about important changes or updates:
| Type of Update | Description | Required Action/Form |
|---|---|---|
| Change in Manufacturer Details | Change of company name, address, or manufacturing site | Submit Form MD5 (Change Notification) |
| Change in Device Information | Changes to device model, specifications, intended use, or design | Submit Form MD5 with updated documents |
| Labeling/IFU Changes | Updates to labeling, instructions for use, packaging information | Submit Form MD5 and revised labels/IFU |
| Reference Market Approvals | Expiry, suspension, or revocation of CE mark, FDA clearance, or other certificates | Notify MDD immediately, provide updated certificates |
| Quality Management System Changes | Changes or lapses in ISO 13485 certification | Inform MDD with supporting documents |
3. Frequency of Updates
Updates should be submitted promptly whenever changes occur.
There is no routine “check-in” or automatic review; the responsibility lies with the Local Responsible Person (LRP) to maintain accurate records and inform MDD.
4. Post-Market Surveillance & Reporting
While not a periodic update, you must maintain a PMS system and report adverse events or field corrective actions.
Reports submitted via Form MD7 keep your registration aligned with current safety status.
5. Voluntary Delisting
If you stop marketing the device in Hong Kong, submit Form MD6 to delist the device.
Remove all references to the registration number from products and marketing materials.
6. Record Keeping
Maintain all relevant documentation for at least 5 years after last supply.
Records must be available for MDD inspection upon request.
Summary Table
| Update Type | Frequency | Action |
|---|---|---|
| Manufacturer/Device Changes | As needed | Form MD5 |
| Labeling & IFU Updates | As needed | Form MD5 |
| Reference Certificate Updates | Immediately upon change | Notify MDD |
| PMS and Incident Reporting | Ongoing | Form MD7 |
| Delisting | When discontinuing device | Form MD6 |
| Record Retention | Minimum 5 years | Maintain files |
Important Notes:
Failure to notify significant changes may lead to suspension or cancellation of your device listing.
Always keep your technical documentation and certificates up-to-date and ready for MDD review.
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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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