After obtaining Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), several important post-registration obligations and considerations must be observed to ensure continued compliance. These obligations relate to device maintenance, surveillance, reporting, and renewal. Here are key aspects to note:

1. Post-Market Surveillance (PMS) Obligations

Once a Class C medical device is registered and available on the market, the manufacturer or local authorized representative must conduct Post-Market Surveillance (PMS) to monitor the device’s performance and safety.

• Collect Performance Data: Gather data from users, healthcare professionals, and facilities to assess the device’s ongoing performance.
• Analyze Adverse Events: Evaluate reports of any adverse events or issues that arise from the use of the device. If there are serious incidents or potential risks, corrective action may be required.
• Risk Management Updates: Continuously update the device’s Risk Management Report based on PMS data and make adjustments to risk controls as needed.

Periodic Safety Updates

• MDACS may require manufacturers to submit periodic safety update reports (PSURs), which summarize the results of the post-market surveillance activities.

2. Adverse Event Reporting

• Report Incidents: Any serious incidents related to the use of the device, especially those that could result in death, serious injury, or device malfunction, must be reported to the Medical Device Control Office (MDCO) within a specified timeframe.
  • Immediate Reporting: Severe incidents must be reported within a defined period (typically 10 to 30 days, depending on the severity).
  • Corrective Actions: If an issue is identified, corrective or preventive measures may need to be implemented, such as device recalls, design changes, or issuing updated user instructions.

3. Compliance with Advertising and Promotional Requirements

• Accurate Advertising: Any promotional material, advertising, or product information must be truthful, accurate, and consistent with the intended use and specifications outlined in the registration.
• No Misleading Claims: Avoid making unsubstantiated or exaggerated claims about the device’s capabilities or intended uses. The advertising should align with the device’s labeling and MDACS requirements.

4. Record-Keeping and Documentation

• Maintain Records: The manufacturer or local authorized representative must maintain comprehensive records related to the manufacture, distribution, and post-market performance of the registered device.
  • Keep records of distribution to facilitate any necessary recalls.
  • Retain documentation of all safety and performance data, including clinical data, PMS reports, and adverse event reports.

5. Device Changes and Modifications

• Notifying MDCO: If there are any significant modifications or changes to the device (such as changes in design, materials, intended use, or performance specifications), these must be reported to the MDCO.
  • Re-Evaluation Required: Changes may require a new conformity assessment or even a fresh registration depending on the nature and extent of the modification.
  • Minor Changes: Some minor changes (such as packaging or labeling updates) may not require full re-registration but still need to be reported.

6. Renewal of Registration

• Validity Period: The registration of a Class C medical device under MDACS typically remains valid for a five-year period.
  • Timely Renewal: You must apply for renewal of the registration before the current registration expires to continue marketing the device in Hong Kong. It's recommended to submit the renewal application 3-6 months prior to expiration.
  • Updated Information: The renewal application may require updated documentation, including proof of continued compliance with regulatory standards, post-market surveillance results, and any changes made to the device.

7. Device Recall or Suspension

• Voluntary Recall: If the device is found to have significant safety issues or defects, the manufacturer may need to initiate a voluntary recall.
  • Follow MDACS guidelines for notifying healthcare providers, distributors, and the public if a recall is necessary.
• MDCO Action: The MDCO has the authority to suspend or revoke the registration if serious non-compliance or safety issues arise.

8. Labeling and Instructions for Use (IFU) Updates

• Keep IFU Up-to-Date: Ensure that the Instructions for Use (IFU) remain current and reflect any new safety information or usage guidelines based on post-market data or regulatory updates.
  • Translations: Labeling and instructions should continue to be provided in both English and Chinese, as required by MDACS.

9. Monitoring of Regulatory Changes

• Stay Informed: Continuously monitor any updates to Hong Kong’s regulatory framework for medical devices, as MDACS guidelines can evolve.
  • Regulatory changes may affect compliance requirements, reporting obligations, or introduce new standards that need to be met.

10. Local Authorized Representative (LAR) Responsibilities

• If the manufacturer is based outside of Hong Kong, the Local Authorized Representative (LAR) must continue to represent the manufacturer in all regulatory matters.
  • Contact Information: Ensure that the LAR's contact details are always up to date with the MDCO.
  • Compliance Support: The LAR must assist with compliance-related obligations, such as adverse event reporting, device modifications, and registration renewals.