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After obtaining Class B medical device registration under the Hong Kong MDACS, there are several important points and ongoing obligations you should be aware of to maintain compliance and ensure smooth market access:
Key Points to Note After Obtaining Class B MDACS Registration
1. Maintain Accurate Device Listing
Keep your device listing information up to date with the Medical Device Division (MDD).
Notify MDD promptly of any changes to the device, manufacturer, or Local Responsible Person (LRP).
2. Compliance with Post-Market Surveillance (PMS)
Implement a post-market surveillance system to monitor device performance and safety in the Hong Kong market.
Report any adverse incidents or complaints related to the device to MDD within specified timelines.
3. Renewal and Annual Reporting
Although MDACS registration itself does not require annual renewal, you must ensure the registration remains valid by complying with any updates or notices from MDD.
Some devices may require periodic renewal or confirmation of continued compliance—confirm with MDD if applicable.
4. Labeling and Packaging Compliance
Continue to ensure that all labeling, packaging, and instructions for use meet MDACS requirements and local language guidelines.
5. Audit and Inspection Readiness
Be prepared for possible inspections or audits by Hong Kong authorities to verify compliance with MDACS and QMS requirements.
Maintain comprehensive and organized documentation.
6. Marketing and Advertising Compliance
Ensure all marketing materials and claims about the device comply with local laws and do not mislead consumers.
7. Local Responsible Person (LRP) Duties
The LRP must remain vigilant and act as the official contact point for any regulatory communication, recalls, or safety actions.
Summary Checklist After Registration
| Task | Description |
|---|---|
| Update Device Info | Notify MDD of changes promptly |
| Post-Market Surveillance (PMS) | Monitor safety, report incidents |
| Compliance & Renewal | Maintain compliance, confirm registration status |
| Labeling & Packaging | Keep materials compliant |
| Inspection Readiness | Keep documentation ready for audits |
| Marketing Compliance | Ensure truthful and legal advertising |
| LRP Responsibilities | Maintain active communication and compliance |
If you want, I can help you draft a post-registration compliance checklist or a template for incident reporting to MDD. Would that be useful?
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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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