Once a Class III medical device has been successfully registered under the MDACS (Medical Device Administrative Control System) in Hong Kong, several important considerations and obligations remain. These are crucial for ensuring ongoing compliance with local regulations and maintaining the device’s legal status in the market.

Here’s what should be noted after obtaining Class III medical device MDACS registration in Hong Kong:

1. Post-Market Surveillance (PMS) Requirements

• Ongoing Monitoring: You must have a Post-Market Surveillance (PMS) Plan in place, which is essential for monitoring the safety, performance, and quality of the medical device once it is on the market.

• Adverse Event Reporting: You are obligated to report any adverse events, product defects, or safety concerns to the Hong Kong Department of Health (DoH) if they occur.

• Periodic Safety Update Reports (PSUR): For Class III devices, periodic reports may be required to demonstrate that the device continues to meet safety and performance standards.

• Field Safety Corrective Actions (FSCA): If issues arise, you must take appropriate corrective actions, which may include recalls, modifications, or warnings about the device.

2. Compliance with Labeling Requirements

• Post-Approval Label Changes: Any changes to the labeling of the device must be consistent with the information provided during registration. The updated labels must comply with local regulations on medical device labeling (e.g., the Medical Device Ordinance (Cap. 599)).

• Instructions for Use (IFU): Ensure that the Instructions for Use are up to date and reflect any new information gathered during the post-market phase, especially with regard to safety and effectiveness.

• Language Requirements: The labeling, packaging, and IFU should be in Chinese and/or English, as required by the Hong Kong authorities.

3. Annual Renewal of Registration

• Registration Validity: MDACS registration is typically valid for five years, but you must apply for renewal before the registration expires.

• Submission for Renewal: Submit an application for renewal well in advance (usually within 3-6 months before expiry), including all updated documentation and any new safety or clinical data if applicable.

4. Device Modifications or Changes

• Notification of Changes: If any major changes are made to the device, such as modifications in design, manufacturing process, or intended use, you must notify the Department of Health and may need to resubmit documents or re-register the device.

• Substantial Changes: Substantial changes that could affect the safety, performance, or classification of the device must be reported to MDACS.

5. Distribution and Importation

• Authorized Representative: If you are not based in Hong Kong, ensure that an authorized representative is appointed locally to act as a point of contact for regulatory matters.

• Importation Requirements: Medical devices, including Class III devices, can only be imported and distributed by registered companies. Importers must ensure that devices are in compliance with MDACS and maintain relevant records.

6. Inspection and Audits

• Facility Inspections: The Hong Kong Department of Health may conduct inspections of manufacturing facilities or local distributors to ensure compliance with regulatory standards.

• Periodic Audits: You should be prepared for periodic audits by the authorities, particularly in relation to the manufacturing processes, quality systems, and post-market surveillance activities.

7. Reporting of Adverse Events and Complaints

• Adverse Event Reporting: As a manufacturer or importer, you are required to report serious adverse events or incidents that could affect the safety or performance of the device to the Department of Health.

• Complaint Handling: You must have a system in place to manage customer complaints and conduct investigations when necessary, including reporting back to authorities in case of serious issues.

8. Maintaining Records

• Device Registration Records: Keep records of all registration documents, including technical files, risk assessments, clinical evaluations, and regulatory approvals from other markets.

• Audit Trail: Ensure that all documentation regarding manufacturing, testing, distribution, and post-market surveillance is readily available for inspection by the Department of Health.

9. Marketing and Advertising

• Advertising Guidelines: Ensure that any advertising or promotional materials for the medical device comply with local regulations. In Hong Kong, medical device advertising is tightly regulated, and any claims made about the device must be substantiated.

• Claims of Efficacy: Ensure that the device is marketed only for the intended purposes and in accordance with the data provided during the registration process.

10. International Compliance

• If the medical device is marketed in other jurisdictions (e.g., EU, US, Canada, Australia), ensure that the device remains compliant with the regulatory requirements in those markets as well. Changes in international regulations may also affect your compliance status in Hong Kong.

11. Penalties for Non-Compliance

• Non-Compliance Consequences: Failure to meet regulatory requirements after obtaining MDACS registration can result in penalties, including warnings, fines, or revocation of registration.

• Product Recall: In extreme cases, a product recall may be required if the device is found to pose significant risk to public health.

Summary of Key Considerations Post-Registration:

1. Ongoing Post-Market Surveillance: Continuous monitoring of device safety and performance.

2. Labeling Compliance: Ensure labeling and instructions are up to date.

3. Registration Renewal: Apply for registration renewal before expiration.

4. Changes to Device: Notify MDACS of any significant modifications or changes to the device.

5. Import and Distribution Compliance: Ensure that importers and distributors follow regulatory guidelines.

6. Adverse Event Reporting: Report adverse events and product complaints as required.

7. Maintain Records: Keep complete records of registration and device history.

8. Adherence to Advertising Rules: Follow strict guidelines for marketing and promotional materials.

9. Global Compliance: Stay compliant with regulatory requirements in other markets.

By staying on top of these ongoing responsibilities, you can ensure the continued compliance of your Class III medical device in Hong Kong, minimizing regulatory risks and protecting the safety and wellbeing of users. If you need further clarification on any specific requirement, feel free to ask!

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