For Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), the application process is rigorous due to the high-risk nature of Class IV devices. The required materials must demonstrate that the device is safe and effective for use.

Materials Required for Class IV Medical Device Registration

Here’s a list of the required materials and how to prepare them:

1. Completed MD-APP Registration Form

• What to prepare:

  • This form is a standard registration form for all medical devices under MDACS. It will ask for basic information about the device, the manufacturer, and the local responsible person (LRP), if applicable.

• How to prepare:

  • Ensure all fields are filled accurately and completely.

  • Make sure the manufacturer’s information is correct, including contact details and regulatory history.

2. Device Description

• What to prepare:

  • Provide a detailed description of the medical device, including:

    • Intended use: What the device is used for, and who the target population is (e.g., patients, healthcare providers).

    • Device specifications: The technical features of the device (e.g., design, composition, function).

    • Instructions for Use (IFU): Detailed instructions on how the device should be used, including safety warnings.

• How to prepare:

  • Include comprehensive, clear, and precise details. Ensure that the information is easy to understand for both technical and non-technical reviewers.

  • The description should align with the intended use and labeling on the device.

3. Regulatory Approvals from Reference Markets

• What to prepare:

  • Evidence of approval in recognized reference markets such as:

    • CE Mark (EU)

    • FDA Approval (USA)

    • PMDA Approval (Japan)

    • TGA Registration (Australia)

    • Health Canada Approval

• How to prepare:

  • Provide certified copies of the approvals or registration documents from at least one of the recognized reference markets.

  • If your device is not approved in these markets, provide additional clinical data and evidence of compliance with international standards.

4. Clinical Data

• What to prepare:

  • Clinical evidence to demonstrate the safety and effectiveness of the device. This could include:

    • Clinical trial reports (if available).

    • Scientific literature supporting the device’s safety and effectiveness.

    • Performance data from the device testing.

• How to prepare:

  • Summarize key clinical studies and results.

  • If applicable, include reports from testing in accredited laboratories.

  • Make sure the data aligns with international clinical evaluation standards (e.g., ISO 14155).

5. Risk Management Documentation

• What to prepare:

  • Risk analysis and risk management plan that identifies potential risks associated with the device and how these risks are mitigated. This includes:

    • Failure Modes and Effects Analysis (FMEA).

    • Hazard identification and risk mitigation measures.

• How to prepare:

  • Provide a comprehensive risk management report.

  • Make sure the risk mitigation strategies align with the device’s design and intended use.

6. Quality Management System (QMS) Documentation

• What to prepare:

  • Proof that the manufacturer complies with ISO 13485 or an equivalent international standard for quality management systems. This includes:

    • Quality policy and management commitment.

    • Design controls, manufacturing processes, and quality control procedures.

• How to prepare:

  • Submit a copy of the ISO 13485 certification or equivalent.

  • Provide a summary of your quality management processes, especially those related to design and production.

7. Device Labeling and Packaging Information

• What to prepare:

  • Samples of the labeling and packaging for the device, which must meet Hong Kong’s regulatory requirements. This includes:

    • Device name, manufacturer’s information, and usage instructions.

    • Warnings and precautions.

    • Storage conditions (if applicable).

• How to prepare:

  • Make sure the labeling complies with ISO 15223 (for medical device symbols) and includes all necessary safety warnings and instructions.

  • Ensure that packaging information is clear, legible, and in both English and Chinese.

8. Declaration of Conformity

• What to prepare:

  • A Declaration of Conformity (DoC) from the manufacturer that the device complies with relevant regulatory requirements.

• How to prepare:

  • The DoC must be signed by the manufacturer’s authorized representative.

  • This should reference the relevant standards (e.g., ISO 13485, ISO 14971) and regulatory approvals from reference markets (e.g., CE, FDA).

9. Local Responsible Person (LRP) Information (if applicable)

• What to prepare:

  • If the manufacturer is located outside of Hong Kong, appoint a Local Responsible Person to act as the point of contact for the Department of Health.

• How to prepare:

  • Provide the LRP's contact details and a formal letter of authorization from the manufacturer appointing them as the representative for the device in Hong Kong.

  • Ensure the LRP understands their role, which includes liaising with the Medical Device Division and coordinating post-market surveillance.

How to Prepare the Application Documents:

1. Organize the Documents:

   • Prepare all documents in an orderly and consistent manner.

   • Create a clear table of contents to help the reviewer navigate the documents.

2. Language Considerations:

   • All documents should be in English or Chinese (both are accepted for submission).

   • If any documents are in other languages, ensure that they are translated into English or Chinese by a certified translator.

3. Ensure Completeness:

   • Double-check that all documents are included and meet the requirements outlined above.

   • Ensure that forms are properly filled out and signatures are in place where required.

4. Electronically or Hard Copy Submission:

   • If submitting electronically, ensure that you use the Hong Kong Department of Health’s online platform and upload the necessary files.

   • If submitting in hard copy, print and organize the materials in a binder or folder, and ensure all documents are clearly labeled.

Summary of Required Documents for Class IV Registration:

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