The Class C medical device registration process under the Hong Kong Medical Device Administrative Control System (MDACS) involves multiple steps that ensure the safety, quality, and effectiveness of the device before it can be legally marketed in Hong Kong. Below is a step-by-step guide to the process, from initial preparation to final approval.

1. Determine Device Classification

Before starting the registration process, you must confirm that the device is classified as Class C under MDACS.

• Risk-Based Classification: MDACS uses a risk-based approach based on the device’s intended use and risk level. Class C devices are moderate- to high-risk devices, such as active diagnostic and therapeutic devices, surgical instruments, and implantable devices.
• Classification Guidelines: Refer to MDACS’s classification guidelines or consult with the Medical Device Control Office (MDCO) to ensure accurate classification.

2. Appoint a Local Authorized Representative (LAR)

If the manufacturer is located outside of Hong Kong, a Local Authorized Representative (LAR) must be appointed. The LAR acts as the point of contact for MDCO and handles all regulatory submissions and communications.

• LAR Responsibilities: The LAR is responsible for the submission of the registration application, adverse event reporting, and post-market surveillance (PMS) obligations.
• LAR Qualifications: The LAR must be a registered business entity in Hong Kong with experience in handling medical devices.

3. Prepare Technical Documentation

The technical documentation is critical to demonstrating the safety and performance of the Class C medical device. You must compile a comprehensive Technical File that includes detailed information about the device’s design, manufacturing, and safety.

Key Documents to Include:

1. Device Description:

   • Detailed description of the device, its intended use, and its function.
   • Information about the device’s components and materials.

2. Risk Management Report:

   • A Risk Management Report in line with ISO 14971 to identify and assess risks associated with the device and outline risk mitigation strategies.

3. Clinical Evidence:

   • Clinical data or studies that demonstrate the safety and performance of the device in accordance with its intended use.
   • Data from clinical trials, if applicable.

4. Manufacturing Process:

   • Description of the manufacturing process and the Quality Management System (QMS), typically compliant with ISO 13485.
   • Details of the facilities involved in manufacturing, including inspection and testing protocols.

5. Labeling and Instructions for Use (IFU):

   • Drafts of labeling and Instructions for Use (IFU) documents in both English and Chinese.
   • Information about the correct use of the device and any warnings or precautions.

6. Declaration of Conformity:

   • A Declaration of Conformity signed by the manufacturer confirming that the device complies with the Essential Principles of Safety and Performance under MDACS.

7. Conformity Assessment Certificates:

   • Certifications or approvals from recognized regulatory bodies (e.g., CE marking, US FDA approval) that demonstrate compliance with international standards.

4. Submit Application to MDCO

Once all technical documentation is prepared, you can submit the registration application to the Medical Device Control Office (MDCO). This can be done electronically or via paper submission, following MDCO’s guidelines.

Key Steps in the Submission Process:

1. Complete Application Form: Fill out the appropriate application form for Class C medical device registration. Ensure that all sections are completed accurately and provide up-to-date information.
2. Attach Technical Documentation: Submit the technical file along with the application form. Ensure that all required documents are included.
3. Pay Application Fees: Pay the applicable fees associated with the registration process. The fee structure may vary based on the complexity of the device and the review required.

5. MDCO Review and Assessment

After the application is submitted, the MDCO will review the documentation to ensure the device meets the necessary safety, quality, and performance requirements. This review involves the following steps:

Technical Review:

• Conformity to Standards: MDCO verifies that the device conforms to the Essential Principles of Safety and Performance as well as relevant international standards (e.g., ISO, IEC).
• Clinical Data Review: Clinical evidence will be reviewed to ensure that the device has undergone sufficient testing and evaluation to prove its safety and effectiveness.
• Risk Assessment: MDCO will assess the Risk Management Report to ensure that all potential risks have been adequately addressed and mitigated.

Additional Requests:

• MDCO may request additional information or clarification if there are any concerns or gaps in the submitted documentation. Responding to these requests promptly can expedite the process.

6. Registration Decision

Once the review process is complete, MDCO will issue a decision regarding the registration.

• Approval: If the device meets all regulatory requirements, MDCO will grant Class C medical device registration.
• Rejection: If the application is incomplete or the device fails to meet safety and performance standards, the application may be rejected. MDCO will provide feedback on the reasons for rejection.

7. Post-Registration Obligations

After obtaining Class C medical device registration, you must comply with post-market obligations to ensure ongoing safety and compliance.

Key Post-Market Obligations:

1. Post-Market Surveillance (PMS): Implement a PMS plan to monitor the device’s performance and safety once it is on the market.
2. Adverse Event Reporting: Report any adverse events related to the device to MDCO, especially those that result in death, serious injury, or device malfunction.
3. Labeling and IFU Updates: Ensure that labeling and Instructions for Use remain up-to-date and are revised if any new safety information becomes available.
4. Periodic Safety Update Reports (PSUR): Submit regular safety update reports summarizing post-market data and any changes in the benefit-risk balance.
5. Renewal: Apply for registration renewal before the five-year registration period expires.

8. Registration Renewal

Class C medical device registrations under MDACS are valid for five years. Before the registration expires, you must submit a renewal application to ensure that the device remains legally on the market.

• Renewal Submission: The renewal process involves submitting updated documentation, including clinical data, post-market surveillance data, and any changes to the device.
• Renewal Timing: Submit the renewal application 3 to 6 months before the expiration date to avoid registration lapses.