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After applying for and obtaining Class B medical device registration under MDACS in Hong Kong, you must comply with several ongoing regulatory requirements and obligations to maintain compliance and market access. Here’s what you need to follow:
Post-Registration Regulations & Requirements for Class B MDACS Devices in Hong Kong
1. Maintain Compliance with the Medical Device Administrative Control System (MDACS)
Keep the device listing current and accurate.
Notify the Medical Device Division (MDD) promptly of any changes to the device or manufacturer using Form MD5 (e.g., labeling, intended use, manufacturer details).
2. Adherence to Essential Principles and Safety Requirements
Continue to ensure the device complies with the Essential Principles of Safety and Performance as per MDACS guidelines (GN-02).
Maintain conformity with applicable international standards and ensure the product remains safe and effective.
3. Post-Market Surveillance (PMS) and Vigilance
Implement a system for monitoring device performance and collecting adverse event data in Hong Kong.
Report any adverse incidents, malfunctions, or risks to the MDD using Form MD7 within prescribed timelines.
Perform field safety corrective actions (FSCA) if necessary and notify authorities.
4. Quality Management System (QMS) Maintenance
Maintain a valid ISO 13485:2016 QMS certificate.
Ensure ongoing compliance with QMS requirements throughout manufacturing and distribution.
5. Labeling and Advertising Compliance
Ensure device labeling, packaging, and instructions for use (IFU) remain compliant with MDACS and are consistent with the approved registration.
Any promotional materials or advertisements must not be misleading and must align with the device’s intended use.
6. Record Keeping and Documentation
Keep records of device distribution, complaints, incidents, and corrective actions for at least 5 years.
Be prepared to provide documentation upon request by Hong Kong authorities.
7. Inspection and Audit Preparedness
The Medical Device Division may conduct random audits or inspections to verify compliance.
Ensure all technical files and QMS documentation are readily accessible.
8. Renewal and Delisting
While MDACS registration does not require renewal, you must notify the MDD if you discontinue supplying the device in Hong Kong via Form MD6 (Voluntary Delisting).
Remove device listing number and references in marketing materials upon delisting.
9. Maintain Valid Reference Market Approvals
Maintain the validity of reference market approvals (e.g., CE, FDA) submitted during registration.
Inform MDD of any revocation or suspension of these approvals.
Summary Table of Post-Registration Compliance
| Requirement | Description | Relevant Forms/Notes |
|---|---|---|
| Change Notification | Notify MDD of changes (e.g., labeling, manufacturer) | Form MD5 |
| Adverse Event Reporting | Report incidents or safety issues | Form MD7 |
| Maintain QMS | Keep ISO 13485 valid and updated | Audit readiness |
| Labeling & Advertising | Ensure accurate, compliant labeling and ads | Follow GN-03 |
| Record Keeping | Maintain records for at least 5 years | Sales, complaints, FSCA |
| Inspection | Be prepared for MDD audits | Maintain documentation |
| Delisting | Notify if device is discontinued | Form MD6 |
| Reference Approvals | Maintain valid CE/FDA, notify changes | Critical for listing |
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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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