Requirements for Class IV Medical Device Registration under Hong Kong MDACS

Class IV medical devices under Hong Kong's Medical Device Administrative Control System (MDACS) are the highest-risk devices and are typically life-sustaining, life-supporting, or implanted devices, such as pacemakers, defibrillators, and ventilators. These devices are subject to strict regulatory scrutiny. While the MDACS registration is currently voluntary, it is often required for public healthcare procurement and market access in Hong Kong.

Here are the key requirements for registering a Class IV medical device under MDACS:

1. Appoint a Local Responsible Person (LRP)

• Requirement: A Local Responsible Person (LRP) must be appointed in Hong Kong if the device manufacturer is located outside Hong Kong.

• Role of LRP:

  • The LRP acts as the official liaison with the Medical Device Division (MDD).

  • Handles the registration process, post-market surveillance, and reports adverse events.

  • Ensures compliance with MDACS requirements, including submitting necessary updates or changes.

2. Confirm Device Classification

• Class IV Devices are those that pose the highest risk to patients. Examples include:

  • Life-supporting or life-sustaining devices (e.g., ventilators, pacemakers).

  • Devices that are implanted or long-term use devices.

  • Devices that affect critical body functions.

• MDACS Classification: The classification follows the Global Harmonization Task Force (GHTF) or IMDRF guidelines, which include factors like invasiveness, duration of use, and the device's intended use.

3. Provide Evidence of Regulatory Approval

To demonstrate the device’s compliance and safety, evidence of prior approval from one or more reference markets must be provided. Acceptable evidence includes:

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

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

• TGA Approval (Australia).

• Health Canada License.

• PMDA Approval (Japan).

Note: The device should already be approved and marketed in one of these regions to qualify for registration in Hong Kong.

4. Provide Quality Management System (QMS) Documentation

• ISO 13485 Certification: The manufacturer should demonstrate compliance with an internationally recognized quality management system, typically ISO 13485, for medical devices.

• The manufacturer’s quality management practices ensure that the device is consistently produced and controlled according to quality standards.

5. Submit Technical and Product Documentation

The following documents must be submitted as part of the registration process:

1. Device Description: A detailed description of the medical device, including its intended use, function, and how it is used.

2. Clinical Data: Evidence of clinical trials or studies supporting the device’s safety and effectiveness.

3. Risk Management: A risk analysis, such as a Failure Mode Effects Analysis (FMEA) or Hazard Analysis.

4. Instructions for Use (IFU): Clear guidelines for the proper use of the device.

5. Device Labeling: Samples of the device’s labels, which must meet regulatory requirements.

6. Declaration of Conformity: A statement that the device complies with relevant regulations, signed by the manufacturer.

6. Complete the MD-APP Registration Form

• The MD-APP (Medical Device Application) form must be filled out and submitted to the Medical Device Division (MDD).

  • This form collects basic details about the manufacturer, device, and the LRP.

7. Submit the Application to the MDD

• The completed application, along with all supporting documents, must be submitted to the Medical Device Division (MDD) of the Department of Health.

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

• As of now, there is no application fee for MDACS registration, though this may change in the future.

8. Evaluation by MDD

• The Medical Device Division (MDD) will assess the application and all documentation submitted.

  • They will verify if the device meets the classification, safety, and performance requirements.

  • If further information or clarifications are required, MDD will contact the applicant.

9. Issuance of Listing Certificate

• If the device passes evaluation, the MDD will issue a Listing Certificate.

• This certificate confirms that the device is officially registered and listed in Hong Kong.

• The device will be included in the Hong Kong Medical Device List, which is referenced by healthcare institutions for procurement.

10. Post-Market Surveillance and Adverse Event Reporting

• Vigilance: Manufacturers and the LRP must implement post-market surveillance systems to monitor the safety and performance of the device after it enters the market.

  • Report any adverse events or safety concerns to the MDD as part of the vigilance system.

• Changes to the Device: Any changes to the device, such as labeling, manufacturing site, or intended use, must be notified to the MDD.

11. Renew and Maintain Registration

• While MDACS registration is currently voluntary, the manufacturer must maintain compliance with the registration requirements, including updates or modifications to the device.

• Future regulations may impose mandatory registration requirements for all medical devices.

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