For Class III medical device MDACS registration in Hong Kong, a comprehensive set of technical documentation is required. This documentation is essential to demonstrate that the device meets the regulatory and safety standards outlined by the Medical Device Division (MDD) of the Hong Kong Department of Health.

Technical Documentation Requirements for Class III MDACS Registration:

1. Device Description and Intended Use

• Detailed Description: Provide a clear and comprehensive description of the device, including its components, materials, and technical features.

• Intended Use: Describe the intended medical purpose(s) of the device, including the target population, the medical conditions it is intended to treat or diagnose, and any special applications.

2. Device Classification Justification

• A justification for classification as a Class III medical device under MDACS. This should include reasoning based on the risk profile and intended use of the device.

• Evidence from internationally recognized standards or classification guidelines (e.g., MDCG guidelines, GHTF) may be included to support the classification.

3. Quality Management System (QMS) Certification

• Provide a copy of the ISO 13485 Certificate. The QMS must be in compliance with international standards for medical devices, covering design, production, and post-market surveillance.

• Certificate of Compliance from an accredited body should be submitted to verify conformity.

4. Regulatory Approval from Other Jurisdictions

• Regulatory Approvals: Submit evidence of approval from at least one reference market (such as the EU, USA, Australia, or Canada). This could include:

  • CE mark (EU),

  • FDA approval (USA),

  • TGA ARTG number (Australia),

  • Health Canada approval.

• Include the Free Sale Certificate (FSC), which certifies that the device is legally marketed and sold in these jurisdictions.

5. Clinical Evaluation Report (CER)

• For Class III devices, a Clinical Evaluation Report (CER) is usually required. This should demonstrate that the device has been clinically tested or clinically evaluated in line with its intended use and meets the safety and performance requirements.

• If applicable, include clinical trial data or post-market surveillance data showing the device’s performance and safety.

6. Post-Market Surveillance (PMS) Plan

• A Post-Market Surveillance (PMS) plan must be submitted to demonstrate how the manufacturer will monitor the device’s performance once it is on the market.

• This includes plans for adverse event reporting, periodic reviews, and customer feedback analysis.

7. Risk Management File

• Risk Assessment: A risk management plan in accordance with ISO 14971 (Risk Management for Medical Devices). This includes identification of potential hazards, evaluation of risks, and mitigation strategies.

• Risk analysis reports showing that the device has been assessed for potential risks to users and patients, including risks associated with its use, materials, and manufacturing process.

8. Labeling and Instructions for Use (IFU)

• Device Labeling: Provide copies of all labels that will be used on the device, including product name, manufacturer information, usage instructions, and safety warnings.

• Instructions for Use (IFU): A comprehensive document that provides detailed instructions on how to use the device safely and effectively. This must include:

  • Indications for use,

  • Contraindications,

  • Warnings and precautions,

  • Proper operation instructions,

  • Maintenance requirements.

9. Technical Specifications

• Detailed technical specifications of the device, including the intended environment of use, physical characteristics, performance characteristics, and operating principles.

• If applicable, provide test reports or performance verification data demonstrating compliance with relevant international standards (e.g., IEC 60601 for electrical medical devices).

10. Manufacturing and Supply Chain Information

• Manufacturing Details: Information about the manufacturing facilities, quality control procedures, and manufacturing processes.

• Supply Chain: Any relevant details regarding the supply chain for materials used in the device (e.g., suppliers, sourcing of critical components).

11. Photos or Drawings of the Device and Packaging

• Submit clear photographs or technical drawings of the device and packaging to help the MDD assess the device’s appearance and labeling.

• Packaging design: Show how the device is packed, especially in terms of sterility and safety (if applicable).

12. Other Supporting Documents

• If the device is a combination product (e.g., device and drug), provide the relevant documentation for both the medical device and the pharmaceutical component.

• Device Software: If the device includes software, a Software Validation Report or Software Risk Management Report may be required.

Summary of Key Technical Documents:

1. Device description and intended use.

2. Classification justification.

3. ISO 13485 certification.

4. Regulatory approval and Free Sale Certificate (FSC).

5. Clinical Evaluation Report (CER).

6. Post-Market Surveillance (PMS) Plan.

7. Risk Management File (ISO 14971).

8. Labeling and Instructions for Use (IFU).

9. Technical Specifications.

10. Manufacturing and Supply Chain Information.

11. Device and packaging photographs.

How to Prepare the Application Files:

• Organize the documents clearly: Ensure each document is complete and correctly labeled.

• Ensure translations: If the documents are in a language other than English or Chinese, certified translations will be required.

• Format and file types: Submit documents in PDF format, unless specified otherwise by the MDD.

If you need further details on any of the specific documents or help preparing them, feel free to ask!

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