After obtaining Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), several important regulatory requirements and ongoing obligations must be followed to ensure continuous compliance. These post-registration responsibilities focus on ensuring the device remains safe and effective for users and that regulatory authorities are informed of any changes or issues. Below are the regulations and requirements that must be followed:

1. Post-Market Surveillance (PMS)

Once the Class C device is registered and on the market, you must conduct ongoing Post-Market Surveillance (PMS) to monitor the device’s performance and safety in real-world conditions.

• PMS Plan: You must implement a Post-Market Surveillance Plan that systematically collects data on device performance. This includes gathering user feedback and monitoring adverse events.
• Device Performance Monitoring: Analyze performance data to detect any potential issues, such as defects, failures, or reduced effectiveness.
• Risk Management: Continuously update the Risk Management Report (per ISO 14971) based on PMS data, revising risk mitigation measures as needed.

2. Adverse Event Reporting

• Incident Reporting: You are required to report any adverse events related to the device to the Medical Device Control Office (MDCO), especially those that result in death, serious injury, or device malfunction.
  • Reporting Timeline: Depending on the severity of the incident, reports must typically be submitted within 10-30 days.
  • Corrective and Preventive Actions: If an adverse event indicates a serious issue, appropriate corrective actions (e.g., recalls, design changes, updated user instructions) must be taken.

3. Reporting Device Modifications

If there are any significant modifications or changes to the device after registration, they must be reported to the MDCO. This includes changes in:

• Design or Materials: Any changes to the design or materials of the device that could affect safety or performance.
• Intended Use: If the intended use of the device changes, this must be reported, and a reassessment of the registration may be required.
• Manufacturing Process: Changes in the manufacturing process that could affect the device's quality or safety.

Some modifications may require a new conformity assessment or even re-registration, depending on their impact.

4. Periodic Safety Update Reports (PSUR)

• Regular Reports: MDACS may require the submission of Periodic Safety Update Reports (PSURs), which provide a summary of post-market data collected through PMS activities. These reports help to demonstrate that the device continues to meet safety and performance standards.
  • The PSUR should include any adverse event data, new clinical evidence, and an evaluation of the benefit-risk balance.

5. Labeling and Instructions for Use (IFU)

• Ensure Consistency: The labeling and Instructions for Use (IFU) must remain accurate and up-to-date. Any updates to labeling, packaging, or IFUs must comply with MDACS requirements and be provided in both English and Chinese.
  • If new safety information becomes available or the instructions need revision, the manufacturer must update the IFU accordingly.

6. Product Recall and Safety Actions

• Voluntary Recalls: If safety concerns arise, the manufacturer may need to initiate a voluntary recall. This must be conducted in accordance with MDACS procedures.
  • Recalls must be reported to the MDCO: If a recall is necessary, it must be immediately reported to the MDCO, and you must follow their guidelines for notifying distributors, healthcare providers, and the public.
• Corrective Action Plan: A recall may also require the submission of a Corrective Action Plan detailing how the issue will be resolved and future risks mitigated.

7. Registration Renewal

• Validity of Registration: A Class C device registration under MDACS is typically valid for a five-year period.
• Timely Renewal: To maintain your registration, you must apply for renewal before the current registration expires. It is recommended to submit the renewal application 3-6 months prior to the expiration date.
  • Updated information may be required as part of the renewal process, including clinical evidence, post-market surveillance data, and any changes to the device.

8. Maintain Compliance with Quality Management System (QMS)

• ISO 13485 Certification: The manufacturer must continue to comply with ISO 13485 or an equivalent quality management system (QMS) standard.
  • The QMS should cover the entire lifecycle of the device, including design, production, storage, and post-market activities.
  • Routine audits and updates to the QMS are required to ensure that quality standards are maintained.

9. Distribution and Traceability

• Maintain Distribution Records: The manufacturer or the Local Authorized Representative (LAR) must keep records of all distribution and sales. This helps to trace any batch or lot in case of a recall or product defect.
  • Lot/Batch Tracking: Ensure that every unit distributed is traceable to its production batch, which is critical for managing recalls or addressing quality issues.

10. Local Authorized Representative (LAR) Responsibilities

If the manufacturer is located outside of Hong Kong, the Local Authorized Representative (LAR) has ongoing obligations to manage regulatory compliance.

• Maintain LAR Status: The LAR must remain the point of contact for the MDCO and handle regulatory communication, incident reporting, and PMS requirements.
• Updated Contact Information: Ensure that the LAR’s contact details are always up-to-date with MDCO.
• LAR’s Compliance Support: The LAR should support the manufacturer with all post-registration obligations, including adverse event reporting and renewal of registration.

11. Ongoing Compliance with International Standards

• Conformity to Standards: The device must continue to meet applicable international standards such as ISO 13485, ISO 14971, IEC 60601, and ISO 10993, where relevant.
  • If international standards are updated, the manufacturer may need to demonstrate that the device remains in compliance with the new versions of these standards.

12. Changes in Regulatory Requirements

• Monitor MDACS Updates: The MDACS framework may evolve over time. It is important to keep up with any changes in Hong Kong’s regulatory requirements and adjust your compliance procedures accordingly.
  • Regulatory Notifications: Stay informed about new regulations, guidance documents, or updates to existing policies issued by the MDCO that may affect your device.

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