To apply for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), certain conditions must be met, as Class IV devices are considered high-risk. Below are the key conditions that must be fulfilled to successfully apply for registration:

1. Compliance with MDACS Requirements

• The medical device must comply with the Medical Device Administrative Control System (MDACS) set by the Hong Kong Department of Health (DH).

• Class IV devices are subject to stringent scrutiny and are required to meet higher regulatory standards due to their potential risk to patient safety.

2. Appoint a Local Responsible Person (LRP)

• If the manufacturer is based outside of Hong Kong, you must appoint a Local Responsible Person (LRP) who is based in Hong Kong.

• The LRP is the official point of contact between the manufacturer and the Hong Kong Department of Health. The LRP will be responsible for ensuring compliance with Hong Kong regulations, including post-market surveillance.

3. Regulatory Approvals in Reference Markets

• The medical device must be approved in at least one recognized reference market such as:

  • European Union (CE Mark)

  • United States (FDA approval)

  • Japan (PMDA approval)

  • Australia (TGA registration)

  • Health Canada

• For Class IV devices, providing regulatory approval from a reference market can help demonstrate that the device meets international safety and performance standards.

4. Evidence of Compliance with International Standards

• The device must meet relevant international standards, which may include:

  • ISO 13485: Quality Management System for medical devices.

  • ISO 14971: Risk management for medical devices.

  • ISO 14155: Clinical investigation of medical devices for human subjects.

  • ISO 15223: Symbols for medical device labeling.

• Provide ISO certificates or other recognized third-party certifications as evidence of compliance.

5. Clinical Data

• Clinical evidence must be provided to show that the device is safe and effective for its intended use. This can include:

  • Results of clinical trials or clinical studies.

  • Post-market surveillance data if the device is already marketed in other countries.

  • Scientific literature supporting the safety and performance claims of the device.

• Clinical data should be generated in compliance with international guidelines, such as those outlined in ISO 14155.

6. Risk Management Documentation

• A risk management plan must be in place that includes:

  • Risk analysis for the device.

  • Risk control measures to mitigate identified risks.

  • The device must adhere to ISO 14971 standards for risk management.

• The application must include a report that details the hazard analysis, including potential failure modes and their impacts on safety.

7. Quality Management System (QMS)

• The manufacturer must have a Quality Management System (QMS) in place that complies with ISO 13485 or an equivalent standard.

• The QMS should cover all aspects of the device's lifecycle, from design and manufacturing to post-market activities.

• The manufacturer should be ISO 13485 certified or provide other proof of a QMS that meets international standards.

8. Device Labeling and Packaging

• The device must comply with labeling requirements, including:

  • Device name and manufacturer details.

  • Intended use and directions for use.

  • Safety warnings and precautions.

  • Storage instructions, if necessary.

• The labeling must be in English or Chinese, and if needed, additional languages can be used.

• The labeling must also comply with international standards, such as ISO 15223 for medical device symbols.

9. Declaration of Conformity

• The manufacturer must provide a Declaration of Conformity (DoC) stating that the device conforms to the applicable standards and regulatory requirements. This should be signed by the authorized representative of the manufacturer.

• The DoC must reference the relevant standards, including those for safety, risk management, and quality control.

10. Post-Market Surveillance and Vigilance System

• The manufacturer should have a post-market surveillance system in place to monitor the device's performance once it is on the market.

• This includes reporting adverse events and implementing corrective actions when needed. The system must comply with ISO 13485 and ISO 14971 standards.

11. Application Fee

• The application fee for Class IV medical device registration must be paid during the submission process. The fee varies depending on the type of device and the complexity of the application.

• Ensure you check the current fee structure on the Department of Health’s official website or the MDACS system.

Conditions for Local Responsible Person (LRP)

• Location: The LRP must be based in Hong Kong and be authorized to act on behalf of the manufacturer.

• Responsibilities: The LRP will be responsible for:

  • Submitting the application.

  • Providing documentation to the Department of Health.

  • Acting as a liaison with the Hong Kong authorities.

  • Ensuring post-market obligations (e.g., product recalls, adverse event reporting).

Summary of Conditions to Apply for Class IV Medical Device Registration in Hong Kong:

By ensuring that all the above conditions are met, you will be able to prepare a robust application for Class IV medical device registration under Hong Kong MDACS.

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