The process for applying for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) involves a series of steps that ensure the device meets all safety, performance, and regulatory requirements before being marketed. Here's an overview of the procedures to follow when applying for Class IV medical device registration:

1. Verify Device Classification

Before applying, ensure that your device is correctly classified as Class IV under Hong Kong's MDACS regulations. Class IV devices are high-risk devices, such as implantable or life-supporting devices, requiring extensive documentation and a thorough evaluation.

2. Prepare Required Documentation

For Class IV medical device registration, you need to submit comprehensive technical documentation, as the device falls under the highest-risk category. The required documentation includes:

• Device Description: A detailed description of the device, including its intended use, specifications, and target patient population.

• Risk Management and Safety Data:

  • Risk analysis, including a report based on ISO 14971 (Risk Management for Medical Devices).

  • Biocompatibility testing (ISO 10993).

  • Electrical safety and performance testing (IEC 60601-1 for active devices).

• Clinical Evaluation: Clinical data demonstrating the device's safety and efficacy, which may include clinical trials or published literature.

• Manufacturing and Quality Control:

  • Manufacturing process descriptions.

  • Proof of compliance with Good Manufacturing Practices (GMP).

• Device Labeling and Instructions for Use (IFU): Compliance with MDACS regulations for labeling, instructions, and safety warnings.

• Certificates and Approvals: Any relevant regulatory certificates such as CE marking, FDA approval, or ISO certifications (e.g., ISO 13485 for quality management).

3. Appoint an Authorized Representative (if applicable)

If the manufacturer is located outside of Hong Kong, an authorized representative in Hong Kong must be appointed. The authorized representative will be responsible for the registration process and handling communications with the Hong Kong Department of Health (DH).

4. Submit the Application

The application for Class IV medical device registration must be submitted through the Hong Kong Department of Health’s MDACS system. The application should include:

• Application Form: Complete the MDACS application form with details about the device, the manufacturer, and the authorized representative (if applicable).

• Technical Documentation: Submit all required documentation, such as the risk management file, clinical data, manufacturing process description, and ISO certifications.

• Payment of Fees: Pay the registration fee, which varies depending on the device class and type. For Class IV devices, the fees will be higher due to the extensive evaluation required.

Where to Submit:

• The Hong Kong Department of Health administers the registration. You can submit your application via their MDACS portal or directly through their official registration system.

5. Evaluation and Review

Once the application is submitted, the Hong Kong Department of Health will conduct a technical evaluation to verify that the device complies with safety, performance, and regulatory requirements.

The review process typically includes:

• Completeness Check: Ensuring that the application is complete and all required documentation is submitted.

• Technical Evaluation: Reviewing clinical data, risk management reports, testing results, and labeling.

• Manufacturing Site Inspection: In some cases, an inspection of the manufacturing facility may be required to verify compliance with Good Manufacturing Practices (GMP).

• Request for Additional Information: If necessary, the Department of Health may request clarification or additional information.

6. Approval and Registration

If the device passes the evaluation, the Hong Kong Department of Health will grant Class IV medical device registration and issue a registration certificate. This allows the device to be marketed and sold in Hong Kong.

7. Post-Approval Requirements

After registration, the following obligations must be fulfilled:

• Post-Market Surveillance: As part of ongoing regulatory compliance, manufacturers must monitor the device's performance on the market and report any adverse events or incidents to the Department of Health.

• Renewal of Registration: Class IV medical device registrations are valid for five years. To maintain the registration, the device must be re-registered before the expiry date.

Summary of Procedures for Class IV Medical Device Registration under MDACS:

1. Verify Device Classification: Ensure that your device is classified as Class IV.

2. Prepare Required Documentation: Collect all necessary documentation, including device descriptions, clinical data, risk management reports, testing data, and quality management certificates.

3. Appoint Authorized Representative: If the manufacturer is overseas, appoint a local authorized representative.

4. Submit Application: Submit the application through the MDACS portal or directly to the Hong Kong Department of Health, along with the required documentation and fee payment.

5. Application Evaluation: The Department of Health will review the application, including technical evaluation and possibly an inspection of the manufacturing site.

6. Approval and Registration: If the device meets all requirements, the Department of Health will issue the registration certificate.

7. Post-Approval Compliance: Ensure post-market surveillance and submit a renewal application every 5 years.

Following these procedures ensures that your Class IV medical device is properly registered and compliant with Hong Kong's MDACS regulatory framework, allowing you to market the device within the region.

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