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After obtaining Class B medical device registration under Hong Kong MDACS, you must follow specific regulations and requirements to ensure ongoing compliance and market access. Here's a summary of the key obligations:
Regulations and Requirements After Obtaining Class B Medical Device Registration under Hong Kong MDACS
1. Maintain Registration Accuracy
Keep your registration details current.
Notify the Medical Device Division (MDD) promptly of any changes related to:
Device design or intended use
Manufacturer information
Local Responsible Person (LRP) details
2. Post-Market Surveillance (PMS)
Implement a system to monitor the safety and performance of the device in the market.
Collect and analyze user feedback, complaints, and incident reports.
Report any adverse events or serious incidents involving the device to the MDD within stipulated timelines.
3. Adherence to Labeling and Advertising Rules
Ensure product labeling and packaging comply with MDACS requirements.
Avoid misleading advertising or claims.
Provide accurate and clear instructions for use in English or Traditional Chinese.
4. Compliance with Quality Management System (QMS)
Maintain a QMS consistent with standards like ISO 13485.
Be ready for potential audits or inspections by Hong Kong authorities.
5. Regulatory Reporting
Submit periodic reports if requested by the MDD.
Participate in recall or corrective action procedures if required.
6. Local Responsible Person (LRP) Duties
The LRP remains the official contact point for regulatory communications.
Ensure timely responses to queries or notices from MDD.
Manage incident reports and coordinate with the manufacturer on compliance matters.
7. Device Modifications
Notify MDD of any significant changes to the device or its manufacturing process.
Obtain approval before marketing modified versions if required.
8. Renewal and Cancellation
Confirm renewal requirements (if any) and keep registration active.
Be aware of grounds for cancellation, such as non-compliance or safety concerns.
Summary Table
| Obligation | Description |
|---|---|
| Registration Update | Notify changes promptly |
| Post-Market Surveillance | Monitor device safety, report incidents |
| Labeling & Advertising | Maintain compliant and truthful materials |
| Quality Management System | Maintain ISO 13485 or equivalent |
| Regulatory Reporting | Submit reports and comply with recalls |
| Local Responsible Person (LRP) | Act as liaison, manage communications |
| Device Changes Notification | Inform MDD of significant modifications |
| Renewal & Cancellation | Ensure active registration status |
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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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