For the periodic updates of Class II medical device MDACS registration in Hong Kong, there are specific standards and processes that manufacturers and authorized representatives must adhere to in order to ensure continued compliance with the Medical Device Administrative Control System (MDACS). These updates are necessary to maintain the registration status of the device and ensure that it continues to meet safety, quality, and regulatory standards.

1. Registration Renewal (Every 5 Years)

• Validity of Registration: The MDACS registration for medical devices is typically valid for 5 years from the date of approval. After this period, the registration must be renewed to continue marketing the device in Hong Kong.

• Renewal Process: To renew the registration:

  1. Submit a renewal application to the Medical Device Control Office (MDCO) at least 6 months before the expiration of the current registration.

  2. Provide updated documentation to demonstrate continued compliance with MDACS regulations.

  3. The renewal application may include updates on the device’s clinical performance, post-market surveillance, labeling changes, or any significant modifications made to the device.

  4. Ensure the Quality Management System (QMS) is still in place and follows ISO 13485 or equivalent standards, including internal audits and corrective actions.

• Required Documentation for Renewal:

  • Updated product information, including any changes to the design, intended use, or manufacturing process.

  • Any updates to clinical data, safety reports, or post-market surveillance results.

  • Labeling updates reflecting changes to safety information, indications, or regulatory approvals (e.g., CE mark or FDA approval).

  • Proof of compliance with applicable international standards (such as ISO standards or IEC standards).

2. Notifying Changes to the MDCO

During the 5-year period, any significant changes to the device, such as modifications to its intended use, design, manufacturer, or materials, must be communicated to the MDCO as part of the periodic updates. You must inform the MDCO of these changes and may be required to submit updated documentation for review.

Common changes that must be reported include:

• Change in Manufacturer: If there is a change in the manufacturing site or the manufacturer of the device, this needs to be reported along with any impact it may have on the safety or performance of the device.

• Changes to Device Design or Intended Use: If the device’s design, indications, or intended use are modified, these changes should be communicated, and updated evidence (e.g., clinical data) may be required.

• New Clinical Evidence: If there are updates to the clinical evaluation or post-market surveillance, including new clinical trials or safety concerns, these should be submitted to MDCO for evaluation.

3. Post-Market Surveillance Reports

• Ongoing Post-Market Surveillance (PMS): After the device is registered and placed on the market, it is essential to continue monitoring its safety and performance through post-market surveillance (PMS). This includes tracking any adverse events and reporting them to MDCO in a timely manner.

• Periodic Safety Update Reports (PSUR): For devices that are subject to ongoing monitoring or have had previous safety issues, you may be required to submit periodic reports detailing the device's performance in the market. This might include data from clinical studies, complaints, and adverse event reporting.

• Risk Management: It is important to maintain an up-to-date risk management file for the device, ensuring that risks are identified, assessed, and mitigated throughout the device’s lifecycle.

4. Audit and Inspection

• Quality System Audits: During the 5-year period, the MDCO may perform inspections or audits of the device’s manufacturing site or quality management system (QMS) to ensure compliance with MDACS regulations. Be prepared to demonstrate that the device continues to meet the required quality and safety standards.

• Corrective Actions: If any issues are identified during the audit or inspection, corrective actions must be implemented, and a corrective action plan should be submitted to the MDCO.

5. Changes in Regulations or Standards

• Regulatory Updates: Ensure that you stay updated on any changes to Hong Kong’s medical device regulations or international standards that may affect your device. If there are new standards that apply to your device (such as changes to ISO 13485, ISO 14971, or IEC standards), you must update your processes and submit relevant evidence to the MDCO.

• Changes in International Certifications: If your device has been certified or approved in other markets (e.g., EU, US), any changes to these certifications should be communicated to the MDCO, as this may impact the regulatory status in Hong Kong.

6. Periodic Review of Device Performance

• Annual or Biennial Reports: Depending on the MDCO’s requirements, you may need to submit an annual or biennial summary report on the device’s safety, performance, and clinical data.

• Performance Data: Provide updates on any new clinical studies, patient feedback, or field data that demonstrate the ongoing safety and effectiveness of the device.

7. Fees and Processing Time for Periodic Updates

• Fees: There may be administrative fees associated with the renewal of registration and the submission of periodic updates. These fees are typically outlined on the MDCO website or in the application guidelines.

• Processing Time: The processing time for periodic updates (renewals, changes, and safety reports) may vary. It is advisable to submit renewal applications and update notifications at least 6 months before the expiration of the registration or any significant changes.

Key Standards for Periodic Updates

• ISO 13485:2016: Quality Management Systems for Medical Devices – Ensure that your device’s quality management system is compliant with this standard.

• ISO 14971:2019: Risk Management for Medical Devices – Regularly review and update your device’s risk management process.

• ISO 10993: Biocompatibility Testing – Ensure that the device continues to meet any applicable biocompatibility standards based on its design and intended use.

• IEC 60601 Series: Safety and Performance of Electrical Medical Equipment – Ensure your device continues to meet the safety and performance standards applicable to medical electrical equipment.

• Hong Kong Medical Device Regulations: Keep up to date with any changes in local regulations governing medical devices in Hong Kong.

Summary

The periodic updates for Class II medical device MDACS registration in Hong Kong focus on ensuring that the device remains compliant with the regulatory requirements over time. The primary steps involve:

1. Renewing registration every 5 years by submitting updated documentation.

2. Notifying the MDCO of significant changes in device design, clinical evidence, or manufacturing.

3. Continuing post-market surveillance and submitting relevant reports to the MDCO.

4. Staying compliant with evolving regulations and updating documentation accordingly.

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