Applying for Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) involves a series of structured steps. Here’s a comprehensive overview of the application process and the required procedures:

Step-by-Step Application Process

1. Determine Device Classification

• Confirm Classification: Verify that your device falls under Class C, which is designated for moderate to high-risk medical devices. You can refer to the Hong Kong Medical Device Classification Guidelines for assistance.

2. Appoint a Local Authorized Representative (LAR)

• If Applicable: If the manufacturer is based outside of Hong Kong, appoint a Local Authorized Representative who is responsible for communicating with the Medical Device Control Office (MDCO) on your behalf. The LAR must be registered in Hong Kong.

3. Prepare Technical Documentation

Compile the necessary technical documents required for the application. Key components include:

• Device Description: Detailed information about the medical device, including its intended use and operating principles.

• Risk Management Report: Conduct a risk assessment according to ISO 14971 to identify potential hazards and document risk control measures.

• Clinical Evidence: Gather data demonstrating the device’s safety and effectiveness. This may include clinical trial results, literature reviews, or post-market surveillance data.

• Quality Management System (QMS) Documentation: Ensure compliance with ISO 13485. Include any relevant certifications or audit reports that demonstrate adherence to quality standards.

• Labeling and Instructions for Use (IFU): Prepare labeling and IFU in both English and Chinese, ensuring they meet regulatory requirements.

• Declaration of Conformity: A signed document stating that the device complies with relevant safety and performance standards.

• Conformity Assessment Certificates: Include any existing certifications, such as CE marking or FDA approval.

4. Complete the Application Form

• Obtain the Form: Download the Class C medical device registration application form from the MDCO website or relevant regulatory authority.

• Fill Out Accurately: Complete the form with accurate and relevant information about the device and manufacturer.

5. Submit the Application

• Compile Submission Package: Gather the application form and all required technical documents into a single submission package.

• Submission Methods: Submit your application via electronic means or in hard copy as specified by MDCO.

• Pay the Registration Fee: Ensure you pay the applicable registration fee at the time of submission. The fee structure is available on the MDCO website.

6. MDCO Preliminary Review

• Initial Screening: After submission, MDCO will conduct a preliminary review to check the completeness of the application. This process may take about 1-2 months.

• Request for Additional Information: If any information is missing or unclear, MDCO will request clarification or additional documentation.

7. In-Depth Technical Review

• Comprehensive Evaluation: MDCO conducts a thorough assessment of the submitted technical documentation, including clinical evidence, risk management, and QMS compliance.

• Time Frame: This stage can take approximately 3-6 months, depending on the complexity of the device and the completeness of the submitted data.

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

• Evaluation of PMS Plan: MDCO will review the proposed PMS plan to ensure that effective monitoring systems are in place to assess the device’s safety and performance once marketed.

• Adverse Event Reporting Mechanism: Ensure you have established processes for reporting adverse events associated with the device.

9. Decision-Making and Issuance of Registration

• Final Decision: MDCO will make a final decision regarding your application. This may take an additional 1-2 months after the technical review is completed.

• Issuance of Registration Certificate: If approved, MDCO will issue a registration certificate for the Class C medical device.

• Notification of Outcome: MDCO will inform you (or your LAR) of the decision, including reasons for rejection if applicable.

10. Post-Registration Obligations

Once the device is registered, you must adhere to ongoing regulatory requirements:

• Post-Market Surveillance (PMS): Implement the PMS plan to monitor the device's safety and effectiveness after it is on the market.

• Adverse Event Reporting: Report any adverse events associated with the device to MDCO promptly.

• Periodic Safety Update Reports (PSUR): Submit regular updates summarizing safety data and any changes in the benefit-risk balance of the device.

• 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: Verify it is Class C.
2. Appoint LAR: If applicable, appoint a Local Authorized Representative.
3. Prepare Technical Documentation: Compile 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 adhering to the MDCO’s requirements, you can effectively navigate the registration process for Class C medical devices under Hong Kong's MDACS.