Procedures and Steps for Class IV Medical Device Registration under Hong Kong MDACS

The Medical Device Administrative Control System (MDACS) in Hong Kong provides a voluntary registration system for medical devices, and Class IV medical devices represent the highest-risk category. These devices typically include life-supporting, life-sustaining, and implanted devices. The procedure for registering Class IV devices under MDACS involves several stages to ensure compliance with the regulatory standards and market access requirements.

Step-by-Step Procedures for Class IV Medical Device Registration

Step 1: Appoint a Local Responsible Person (LRP)

• Requirement: If the manufacturer is outside Hong Kong, they must appoint a Local Responsible Person (LRP) based in Hong Kong.

• Role of LRP: The LRP acts as the official representative for the manufacturer in Hong Kong. They are responsible for managing the registration process, communications with the Medical Device Division (MDD), post-market surveillance, and reporting any adverse events.

Step 2: Verify Device Classification

• Class IV Devices: These include high-risk devices like pacemakers, ventilators, heart valves, or implantable devices.

  • Ensure that your device meets the classification criteria for Class IV.

  • The classification is typically based on:

    • Intended use of the device

    • Duration of use

    • Invasiveness (e.g., implantable or long-term use)

    • Critical function (e.g., life-supporting)

• Classification Reference: Follow MDACS classification guidelines, which are aligned with the Global Harmonization Task Force (GHTF) and IMDRF standards.

Step 3: Prepare Required Documentation

You will need to gather and submit comprehensive technical documentation as part of your registration. The required documents generally include:

1. Evidence of Regulatory Approval from a Reference Market:

   • Provide valid approval from one of the following recognized reference markets:

     • CE Marking (EU) under MDR (Medical Device Regulation) or IVDR (In Vitro Diagnostic Regulation)

     • FDA Approval (USA) – either PMA or 510(k)

     • TGA Certificate (Australia)

     • Health Canada License

     • PMDA Approval (Japan)

   • The device should be approved and legally marketed in one of these jurisdictions.

2. Quality Management System (QMS):

   • Provide evidence of compliance with international standards such as ISO 13485 (Quality Management for Medical Devices).

3. Device-Specific Documentation:

   • Device description

   • Instructions for Use (IFU)

   • Risk analysis and assessment

   • Clinical evidence (if applicable)

   • Device labeling samples

   • Declaration of Conformity (signed by the manufacturer)

4. Completed Application Form:

   • Fill out the MD-APP Form for medical device registration under MDACS.

Step 4: Submit the Application

• Submit the completed application form and all supporting documentation to the Medical Device Division (MDD) of the Department of Health.

  • The submission can be done electronically or in hard copy.

  • Ensure that all required documents are included to avoid delays.

  • Application fee: As of now, MDACS does not charge an application fee, though this could change in the future.

Step 5: Evaluation by MDD

• The Medical Device Division (MDD) will review the submitted application.

  • They will evaluate whether the device meets the classification, safety, and performance standards.

  • If additional information or clarification is required, MDD will request it from the applicant.

• Timeline for Evaluation:

  • The review process can take several weeks to a few months, depending on the complexity of the device and completeness of the documentation.

Step 6: Issuance of Listing Certificate

• If the application is approved, the MDD will issue a Listing Certificate, officially registering the Class IV device under MDACS.

• The device will be included in the Hong Kong Medical Device List, and it will be available for procurement by hospitals and other healthcare providers.

Step 7: Post-Market Surveillance and Reporting

• Post-Market Surveillance: The manufacturer and LRP must implement a system for monitoring the device’s performance and safety in the market.

• Adverse Event Reporting: If there are any adverse events or device-related issues, these must be reported to the MDD as part of the vigilance system.

• Notifying Changes: Any changes to the device (e.g., manufacturing site, labeling, intended use) must be notified to the MDD.

Step 8: Renewal and Updates

• Maintenance of Registration: The manufacturer must ensure that all updates related to safety, regulatory changes, or product modifications are communicated to the MDD.

• While MDACS is currently voluntary, keep in mind that future regulations may make certain aspects of registration mandatory.

Summary of Steps

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