Procedures for Class IV Medical Device Registration under Hong Kong MDACS

The Medical Device Administrative Control System (MDACS) is a voluntary system for registering medical devices in Hong Kong. For Class IV devices, which are the highest risk, the registration process is more rigorous due to the potential impact on patient health. Here are the procedures for registering a Class IV medical device:

Step-by-Step Registration Procedures:

1. Determine Device Classification

• Class IV devices include high-risk devices that are life-supporting, life-sustaining, implanted, or have a high risk of serious adverse health consequences if they fail (e.g., pacemakers, defibrillators, ventilators).

• Ensure that the device meets the criteria for Class IV as defined under MDACS.

2. Appoint a Local Responsible Person (LRP)

• If your company is not based in Hong Kong, you must appoint a Local Responsible Person (LRP) in Hong Kong.

• The LRP will be your official contact for the Department of Health’s Medical Device Division (MDD) and will help manage the registration process.

• The LRP is responsible for ensuring that the medical device complies with Hong Kong’s regulatory requirements and coordinates post-market surveillance.

3. Prepare Required Documents

The following documents are required for registration:

• Device Description: A detailed description of the medical device, including its intended use, features, and how it operates.

• Regulatory Approvals from Reference Markets: Proof of approval for the device from one of the recognized reference markets, such as:

  • CE Mark (EU)

  • FDA Approval (USA)

  • TGA Registration (Australia)

  • PMDA Approval (Japan)

  • Health Canada License

• Clinical Data: Evidence of clinical trials or evaluations demonstrating the safety and effectiveness of the device.

• Risk Management Documentation: A risk analysis (e.g., Failure Modes and Effects Analysis or FMEA) identifying potential hazards associated with the device and how risks are mitigated.

• Quality Management System (QMS) Documentation: Proof of compliance with ISO 13485 or equivalent international standards for quality management systems.

• Instructions for Use (IFU): Detailed instructions for the proper use and operation of the device.

• Device Labeling: Labeling must meet regulatory requirements, including appropriate warnings, usage instructions, and contact information.

• Declaration of Conformity: A statement by the manufacturer declaring that the device meets the relevant regulatory requirements.

4. Complete the MD-APP Registration Form

• Fill out the MD-APP Registration Form provided by the Medical Device Division (MDD).

• The form will request basic information about the device, manufacturer, and the appointed LRP.

5. Submit the Application

• Submit the completed MD-APP form along with all the required documents to the Medical Device Division (MDD).

6. Evaluation by the Medical Device Division (MDD)

• Once the application is submitted, the MDD will assess the device’s documentation.

• If the MDD needs additional information or clarification, they will contact the applicant.

7. Issuance of Listing Certificate

• If the application meets all regulatory requirements, the MDD will issue a Listing Certificate.

• This confirms that the device is listed under MDACS and can be legally marketed in Hong Kong.

8. Post-Market Surveillance

• Post-market surveillance is crucial for maintaining compliance. The manufacturer or LRP must monitor the device's performance in the market.

• Any adverse events or safety concerns must be reported to the MDD.

• Corrective actions (e.g., recalls, safety warnings) may be required if new risks are identified.

9. Renewal and Maintenance

• The MDACS registration is subject to periodic updates. If there are any changes to the device (e.g., design, labeling, manufacturing site), the MDD must be notified.

• Manufacturers should ensure that the device complies with any changes to regulations or safety standards.

Required Documents for Registration:

1. Application Form (MD-APP): Completed MD-APP form for medical device registration.

2. Manufacturer Details: Information about the manufacturer, including contact details, site address, and evidence of regulatory compliance in other jurisdictions.

3. Device Description: Detailed description of the device, including its intended use, technical specifications, and features.

4. Clinical Evidence: Clinical trial data, performance data, or scientific literature to support safety and effectiveness.

5. Risk Management Files: Documents related to risk analysis, including FMEA, hazard identification, and risk mitigation measures.

6. Quality Management System (QMS) Documents: Proof of compliance with ISO 13485 or equivalent.

7. Regulatory Approvals: Evidence of regulatory approvals in reference markets such as the EU (CE Mark), USA (FDA), or Japan (PMDA).

8. Instructions for Use (IFU): Detailed, user-friendly instructions for the proper use of the device.

9. Device Labeling: Samples of the device’s labels, including all required information (e.g., device name, manufacturer, usage instructions).

10. Declaration of Conformity: A formal statement from the manufacturer confirming that the device complies with applicable regulations.

Key Considerations for Class IV Medical Device Registration under MDACS:

• Local Responsible Person (LRP): If the manufacturer is located outside of Hong Kong, appointing a Local Responsible Person is mandatory for handling communications with the Department of Health and ensuring ongoing compliance.

• Regulatory Approvals: Devices must typically have prior regulatory approval in a recognized jurisdiction (e.g., CE, FDA). If the device is not approved in these regions, additional clinical data may be required.

• Quality Assurance: Manufacturers must demonstrate compliance with international quality standards, such as ISO 13485, to ensure consistent quality throughout the product lifecycle.

• Post-Market Surveillance: Ongoing monitoring of device performance is required to detect any potential issues after market introduction.

• Time and Costs: The registration process can take several months (up to 12 months), and while there are no application fees, additional costs related to appointing an LRP, document translation, and post-market surveillance may apply.

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