The process for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) is detailed and involves several critical steps to ensure compliance with Hong Kong’s medical device regulatory requirements.

Here’s a step-by-step guide for the Class IV medical device registration process under MDACS:

1. Pre-Application Preparations

Verify Device Classification:

• Class IV devices are the highest-risk category and require the most extensive regulatory documentation.

• Ensure your device is correctly classified as Class IV according to the MDACS classification criteria. This typically includes devices with high risk, such as implantable devices, active devices that are life-supporting, or diagnostic devices intended for serious conditions.

Prepare the Necessary Documentation:

• Technical Documentation: Prepare detailed technical files for the device, including:

  • Design and manufacturing processes

  • Risk management files

  • Clinical data (clinical investigations or literature reviews)

  • Biocompatibility testing (if applicable)

  • Performance testing and safety data

  • Instructions for Use (IFU) and labeling

  • Post-market surveillance data (if applicable)

• Compliance with Standards: Ensure compliance with applicable international standards such as:

  • ISO 13485 (Quality Management System)

  • ISO 14971 (Risk Management)

  • ISO 10993 (Biocompatibility)

  • IEC 60601-1 (Electrical safety for active medical devices, if applicable)

Appoint a Local Authorized Representative (if applicable):

• If the manufacturer is based outside Hong Kong, you will need to appoint an authorized representative in Hong Kong to handle the registration process.

2. Submit the Application

Application Portal:

• Applications for registration under MDACS are typically submitted via the Hong Kong Department of Health’s website or the MDACS portal.

Application Form:

• Complete the Class IV medical device registration form. This form includes device information, manufacturer details, and the proposed authorized representative (if applicable).

Documents to Submit:

• Technical documentation (detailed above)

• Certificate of free sale or other evidence of marketing authorization in another country (such as CE marking or FDA approval)

• Declaration of Conformity or equivalent statement

• Labeling and Instructions for Use (IFU) for the device

• Post-market surveillance plan (if applicable)

• Authorized representative details (for foreign manufacturers)

Payment of Application Fees:

• Payment for the registration fees must be made when submitting the application. The fee structure varies based on the device class and may include additional costs for inspections or assessments.

3. Evaluation of Application

Technical Evaluation:

• The Hong Kong Department of Health will review the application and evaluate the technical documentation provided. This includes assessing compliance with local and international safety, performance, and quality standards.

Device Safety and Effectiveness:

• For Class IV devices, the Department of Health will focus on the device’s safety, clinical effectiveness, and risk management procedures.

Inspection (if required):

• Depending on the device type, the Department of Health may request an inspection of the manufacturing facilities to verify adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.

4. Approval or Request for Additional Information

Approval:

• If the application meets all regulatory requirements, the Department of Health will issue a medical device registration certificate for the Class IV device.

Request for Additional Information:

• If there are gaps in the submitted documentation or if additional clarifications are needed, the Department of Health may request further information from the manufacturer.

• Manufacturers must respond to these requests in a timely manner to prevent delays in the registration process.

5. Post-Approval Requirements

Maintain Compliance:

• After the device has been registered, the manufacturer must comply with ongoing regulatory requirements, including:

  • Post-market surveillance and reporting of adverse events

  • Quality management system (QMS) compliance under ISO 13485

  • Renewal of registration (every 5 years)

Adverse Event Reporting:

• Manufacturers must report any adverse events or safety issues related to the device, as required by the Department of Health.

6. Periodic Renewal

Renewal Application:

• Medical device registrations under MDACS are valid for 5 years.

• To maintain registration, a renewal application must be submitted before the expiration date with updated technical documentation, post-market surveillance data, and adverse event reports.

Key Considerations During the Process

1. Timeliness: Ensure that you submit your application well in advance of the intended market launch to account for possible delays in the approval process.

2. Complete Documentation: Make sure all technical documentation is thorough, accurate, and up to date.

3. Authorized Representative: Foreign manufacturers must appoint a local authorized representative to manage the registration process.

4. Risk Management: Since Class IV devices are high-risk, ensure that you have comprehensive risk management procedures in place and that you provide evidence of these practices during the registration process.

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

1. Pre-Application Preparation:

   • Verify device classification

   • Prepare technical documentation and compliance evidence

   • Appoint an authorized representative (if applicable)

2. Submit Application:

   • Complete the application form

   • Submit required documents (technical files, clinical data, labeling, etc.)

   • Pay registration fees

3. Evaluation:

   • Technical and safety evaluations by the Department of Health

   • Possible inspection of manufacturing facilities

4. Approval or Additional Information:

   • Receive approval or respond to requests for more information

5. Post-Approval Requirements:

   • Maintain compliance with post-market surveillance, reporting, and QMS requirements

6. Renewal:

   • Submit renewal application every 5 years

By following these steps and ensuring that all regulatory requirements are met, manufacturers can successfully register their Class IV medical devices under Hong Kong's MDACS system and bring their products to market.

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