The regular renewal of a B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong follows specific standards and processes. The renewal process is essential to ensure the device continues to meet safety, performance, and regulatory requirements throughout its lifecycle. Here's an overview of the standards and steps involved in the renewal process:

1. Standards for Regular Renewal

To maintain compliance during the renewal of your B-class medical device MDACS registration, the following standards must be met:

a. Continued Compliance with Essential Principles

• Essential Principles of Safety and Performance: Ensure that the device continues to comply with the Essential Principles of Safety and Performance set out by the MDCO. These principles require that the device remains safe, effective, and fit for its intended purpose.

b. Adherence to Updated International Standards

• ISO 13485 Compliance: The device’s manufacturing processes and quality management system (QMS) must still comply with ISO 13485 for medical devices. This standard ensures ongoing quality control, risk management, and adherence to good manufacturing practices.
• Relevant Device-Specific Standards: Ensure that the device remains compliant with any specific international standards that apply to its category, such as:
  • ISO 14971 for risk management.
  • IEC 60601 for electrical medical devices.
  • ISO 10993 for biocompatibility, if applicable.

c. Post-Market Surveillance and Vigilance Requirements

• Post-Market Surveillance (PMS): Maintain a functional PMS system and ensure all data collected from post-market surveillance activities (e.g., complaints, adverse events) are documented and reflected in the renewal submission.
• Vigilance Reporting: Ensure that all adverse events and Field Safety Corrective Actions (FSCA) are reported to the MDCO as required. Any unresolved safety issues or recurring incidents should be disclosed during renewal.

d. Labeling and Documentation Updates

• Labeling Compliance: All labeling, including Instructions for Use (IFU), must continue to comply with Hong Kong’s regulatory requirements and should be updated to reflect any changes in the device’s design, materials, intended use, or risk profile.
• Regulatory Updates: Ensure that any updates to local regulations or standards have been incorporated into your device’s labeling, packaging, and instructions.

2. Processes for Regular Renewal

The renewal of MDACS registration is typically required at regular intervals to keep the device listed and approved for marketing in Hong Kong. Below are the processes involved:

a. Pre-Renewal Preparation

1. Verify Registration Expiry Date: Determine the current registration’s expiry date and start the renewal process well in advance. This helps avoid lapses in the device's market approval.
2. Gather Updated Documentation: Collect and prepare updated documentation related to the device’s safety, performance, and compliance. This may include:
   • Post-Market Surveillance (PMS) Reports: Summarize any issues, adverse events, or corrective actions taken during the registration period.
   • Risk Management File: Update the ISO 14971 risk management report to reflect any new risks identified through post-market experience.
   • Clinical Evaluation Report (CER): If applicable, update the Clinical Evaluation Report (CER) to include new clinical data or performance information gathered from post-market use.
   • Test Reports: If any new tests have been performed on the device (e.g., biocompatibility, electrical safety, or performance), include the latest results in the renewal submission.
   • Device Changes Documentation: If any changes have been made to the device’s design, materials, or manufacturing process, include detailed documentation of these changes and an assessment of their impact on safety and performance.

b. Renewal Application Submission

1. Submit a Renewal Application: Submit a formal renewal application to the Medical Device Control Office (MDCO) before the current registration expires. This application typically includes:

   • Updated Technical Documentation: Ensure that all technical documentation is up to date, including any changes made to the device.
   • Compliance Statements: Submit a statement confirming that the device continues to meet the Essential Principles of Safety and Performance and any updated international standards.
   • Post-Market Surveillance (PMS) Summary: Provide a summary of the post-market surveillance activities, including any corrective actions or recalls that have taken place since the last registration.

2. Include a Declaration of Conformity: A Manufacturer’s Declaration of Conformity is required to state that the device still conforms to the applicable regulations, standards, and safety requirements.

   • This declaration must be signed by the manufacturer or the Authorized Representative (AR), and it should be supported by updated technical documentation, risk assessments, and testing reports.

c. Compliance Review by MDCO

• MDCO Review: Once the renewal application is submitted, the Medical Device Control Office (MDCO) will review the updated documentation, PMS data, and any changes made to the device.
  • The review process ensures that the device continues to meet all regulatory standards, including updated international standards (e.g., ISO, IEC).
  • The MDCO may request additional documentation or clarifications if there are concerns or discrepancies.

d. Address MDCO Queries or Requests

• Respond to Requests for Information (RFIs): If the MDCO requests more information or clarification, respond promptly to avoid delays. Additional testing, risk assessments, or updated clinical data may be requested to support the renewal application.

e. Renewal Approval

• Approval of Renewal: Once the MDCO is satisfied with the submission, they will approve the renewal and issue a new registration certificate with an extended validity period.
  • The renewed registration typically remains valid for a few years (e.g., 2 to 5 years, depending on regulatory updates).
  • It’s essential to keep the registration certificate and other important documents up to date in case of future audits or inspections.

3. Key Considerations for Renewal

a. Renewal Timeframe

• Start Early: It is recommended to begin preparing the renewal application 6 to 12 months before the current registration expires to allow sufficient time for collecting necessary documentation and resolving any issues that may arise.

b. Device Modifications

• Significant Changes: If there have been any significant changes to the device, such as design modifications, material changes, or alterations in manufacturing processes, these must be reported as part of the renewal process.
  • Significant changes may require additional conformity assessments or even a new registration submission, depending on their impact on the device’s classification or risk profile.

c. Fees

• Renewal Fees: Be prepared to pay the necessary registration renewal fees as required by the MDCO. These fees typically cover the administrative costs of reviewing the renewal submission and maintaining the device's listing in the MDACS database.

d. Post-Renewal Compliance

• Ongoing Surveillance: After renewal, maintain all PMS systems, complaint handling processes, and vigilance reporting mechanisms to ensure continued regulatory compliance.
• Labeling Updates: If there are any new risks or changes to the device, ensure that the labeling and Instructions for Use (IFU) are updated accordingly and submitted to the MDCO.

Summary of the Renewal Process

1. Start the Renewal Process Early: Ideally, begin preparing for renewal 6 to 12 months before the registration expiry date.
2. Update Technical Documentation: Ensure that the technical file, risk management report, clinical evaluation report (if applicable), and PMS data are up to date.
3. Submit the Renewal Application: Submit the completed renewal application to the MDCO with updated documentation, a declaration of conformity, and the necessary fees.
4. Respond to MDCO Queries: Address any requests for information or additional documentation promptly.
5. Receive Renewal Approval: Once approved, the renewed registration will be valid for a new term, ensuring that the device remains on the Hong Kong market.
6. Maintain Ongoing Compliance: Continue post-market surveillance and vigilance reporting to monitor the device’s safety and performance.

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