Applying for Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) involves several steps and procedures to ensure compliance with local regulations. Here’s a detailed guide on how to apply and the associated procedures:

Step-by-Step Application Process

1. Determine Device Classification

• Confirm Class C Status: Ensure that your device is classified as Class C based on the MDACS classification criteria, which indicates a moderate to high risk level.

2. Appoint a Local Authorized Representative (LAR)

• If Based Outside Hong Kong: If the manufacturer is not based in Hong Kong, appoint a Local Authorized Representative who will act as a liaison with the Medical Device Control Office (MDCO). The LAR must be registered in Hong Kong and can facilitate the application process.

3. Prepare Technical Documentation

Compile the required technical documentation to support your application. This documentation should demonstrate that the device meets the necessary safety and performance standards. Key documents include:

• Device Description: Comprehensive details about the medical device, its intended use, and operation.
• Risk Management Report: Conduct a risk assessment according to ISO 14971 to identify potential hazards and risk mitigation measures.
• Clinical Evidence: Provide data demonstrating the device's safety and efficacy. This can include results from clinical trials, literature reviews, or post-market studies.
• Quality Management System (QMS) Documentation: Ensure compliance with ISO 13485. Include any relevant certifications or audit reports.
• Labeling and Instructions for Use (IFU): Prepare clear labeling and instructions in both English and Chinese, ensuring they meet regulatory requirements.
• Declaration of Conformity: A signed document confirming compliance with applicable safety and performance standards.
• Conformity Assessment Certificates: Include any relevant certification such as CE marking or FDA approval.

4. Complete the Application Form

• Obtain the application form for Class C medical device registration from the MDCO website or relevant regulatory body.
• Fill out the form accurately, providing all required details about the device and the manufacturer.

5. Submit the Application

• Compile the Submission Package: Gather the completed application form and all technical documentation.
• Submission Methods: Submit your application via electronic means or in hard copy as specified by the MDCO. Make sure to follow the guidelines on the format and submission method.
• Pay the Registration Fee: Include payment for the applicable registration fee as stipulated by MDCO.

6. MDCO Preliminary Review

• Initial Screening: MDCO will conduct a preliminary review of the application to check for completeness and accuracy. This may take about 1-2 months.
• Additional Information Request: If any information is missing or unclear, MDCO will contact you for clarification or additional documentation.

7. In-Depth Technical Review

• Comprehensive Evaluation: MDCO performs a thorough evaluation of the submitted technical documentation, including clinical evidence, risk management, and quality management system compliance.
• Time Frame: This stage can take around 3-6 months, depending on the complexity of the device and any supplementary data required.

8. Review of Post-Market Surveillance (PMS) Plan

• PMS Plan Evaluation: MDCO reviews the proposed PMS plan to ensure that systems are in place to monitor the device's performance and safety once on the market.
• Adverse Event Reporting Mechanism: Ensure that there are processes for reporting any adverse events related to the device.

9. Decision-Making and Issuance of Registration

• Final Decision: After completing the technical review, MDCO will make a decision regarding the registration of the device. This may take an additional 1-2 months.
• Issuance of Registration Certificate: If the application is approved, MDCO will issue a registration certificate for the Class C medical device.
• Notification of Outcome: MDCO will inform the applicant (or LAR) of the decision, including reasons for any rejection if applicable.

10. Post-Registration Obligations

Once registered, you must comply with ongoing regulatory requirements:

• Post-Market Surveillance (PMS): Implement the PMS plan to monitor the device's safety and effectiveness after it is marketed.
• Adverse Event Reporting: Report any adverse events related to the device to MDCO as required.
• Periodic Safety Update Reports (PSUR): Submit regular updates summarizing safety data and any changes in the device’s benefit-risk balance.
• Renewal of Registration: The registration is valid for 5 years. Apply for renewal before expiration, ensuring that updated technical documentation is included.

Summary of Procedures for Class C Medical Device Registration

1. Confirm Device Classification: Ensure it is Class C.
2. Appoint LAR: If applicable, appoint a Local Authorized Representative.
3. Prepare Technical Documentation: Compile all necessary documents.
4. Complete Application Form: Fill out the registration form accurately.
5. Submit Application: Send the application package and pay the fee.
6. Preliminary Review: MDCO checks for completeness.
7. In-Depth Technical Review: MDCO conducts a comprehensive evaluation.
8. PMS Plan Review: MDCO reviews the post-market surveillance plan.
9. Decision and Issuance: MDCO makes a final decision and issues registration.
10. Post-Registration Compliance: Monitor device performance and report as required.

By following these steps and procedures diligently, you can successfully navigate the registration process for Class C medical devices under the Hong Kong MDACS.