To apply for Class III medical device MDACS registration in Hong Kong, certain conditions must be met. These conditions ensure the device complies with the requirements for high-risk medical devices and that all regulatory processes are in place. Below are the key conditions that must be fulfilled:

🛠️ Conditions for Applying for Class III MDACS Registration

1. Device Classification as Class III

• The device must be classified as Class III under the MDACS system. Class III medical devices are those that are high-risk and may pose significant risk to patient safety.

• Class III devices include implantable devices, devices that support or sustain life, or those used for critical therapeutic purposes.

• The device’s classification should be justified based on its intended use, risk to the user, and its regulatory status in other jurisdictions.

2. Manufacturing Compliance with ISO 13485

• The manufacturer must have a Quality Management System (QMS) in place that complies with ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes).

• A valid ISO 13485 certificate must be issued by an accredited body, confirming that the manufacturer follows recognized quality control standards.

3. Regulatory Approval in Reference Markets

• The medical device must have been approved for sale or marketing in at least one reference market such as:

  • EU (CE mark under MDR or AIMDD),

  • USA (FDA 510(k) or PMA),

  • Australia (TGA ARTG), or

  • Canada (Health Canada).

• Evidence of approval in these jurisdictions (e.g., CE certificate, FDA clearance, or equivalent) is required as part of the application.

4. Free Sale Certificate (FSC)

• A Free Sale Certificate (FSC) must be provided. This certificate confirms that the device is legally marketed and available for sale in the reference market country.

• The FSC is typically issued by the regulatory authority of the country where the device is marketed.

5. Appointment of a Local Responsible Person (LRP)

• The manufacturer must designate a Local Responsible Person (LRP) in Hong Kong. The LRP must be a Hong Kong-based entity (company or legal person) responsible for communication with the Medical Device Division (MDD) and ensuring compliance with MDACS regulations.

• The LRP is responsible for managing the application process, including submission of the MDRR-1 form, and fulfilling post-market obligations like vigilance and reporting incidents.

6. Preparation of Required Documents

• The manufacturer must prepare and submit a comprehensive set of documents, which includes:

  • The MDRR-1 Form (completed and signed),

  • Device description, intended use, and classification justification,

  • Clinical Evaluation Report (CER), especially for high-risk or implantable devices,

  • Post-market Surveillance (PMS) Plan,

  • Photos of device and packaging,

  • Technical documentation including labels, instructions for use, and manufacturing details.

7. Compliance with Hong Kong’s Safety and Performance Standards

• The medical device must meet the safety and performance requirements specified under Hong Kong’s Medical Device Ordinance (Cap. 599) and MDACS.

• The device must also comply with relevant international standards (e.g., ISO 14971 for risk management, IEC 60601 for electrical medical devices).

8. Device’s Market Status and History

• The device should already be marketed in a recognized jurisdiction. New or experimental devices might face more scrutiny and may require additional documentation or clinical data.

• Clinical data or post-market surveillance reports may be required to demonstrate the safety and effectiveness of the device, especially for high-risk or innovative products.

9. No Outstanding Regulatory Issues

• The manufacturer or its Hong Kong LRP should ensure there are no outstanding regulatory or compliance issues in the reference market. The manufacturer should not be under regulatory investigation or sanctions.

10. Device Is Not Prohibited or Restricted in Hong Kong

• The device must not be subject to any prohibition or restriction in Hong Kong. If the device is under any form of ban or restriction, the application will be rejected.

Summary of Key Requirements:

1. Device classification as Class III.

2. ISO 13485 certification.

3. Regulatory approval in at least one recognized jurisdiction (CE, FDA, TGA, etc.).

4. A valid Free Sale Certificate (FSC).

5. Appointment of a Local Responsible Person (LRP) in Hong Kong.

6. Completion of all required documentation.

7. Compliance with safety and performance standards.

8. No outstanding regulatory issues.

9. Device not under prohibition or restriction in Hong Kong.

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