For Class II medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you are required to submit comprehensive technical documentation to demonstrate the safety, efficacy, and compliance of the device. These documents help to ensure that the device meets the relevant regulatory standards.

Key Technical Document Requirements for Class II MDACS Registration:

1. Application Form (Form MD-1)

• The completed application form (MD-1) is required for submission. This form requests basic information about the device, including its intended use, classification, and manufacturer.

2. Device Description and Intended Use

• A detailed description of the medical device, including its:

  • Name and model of the device.

  • Intended use (e.g., diagnostic, therapeutic, monitoring).

  • Indications for use and any contraindications.

  • Working principles and technical characteristics.

  • Product design, including materials used, dimensions, and other relevant specifications.

  • If the device has different models, variants, or accessories, describe them as well.

3. Manufacturing Information

• Details of the manufacturer:

  • Manufacturer’s name, address, and contact information.

  • Proof of good manufacturing practices (e.g., ISO 13485 certification).

  • Certificate of Free Sale (CFS) from the country of origin (if applicable).

• Manufacturing site: Information about the facilities where the device is made, ensuring that it meets GMP standards.

4. Risk Management Documentation

• A risk analysis must be performed for the device to meet ISO 14971 standards. This document should include:

  • Identification of risks associated with the device.

  • Risk control measures taken to mitigate those risks.

  • Risk-benefit analysis.

  • Post-market surveillance plans, if applicable.

5. Evidence of Compliance

• Conformity Assessment: Proof that the device meets international standards or regulatory requirements:

  • CE Marking (for EU compliance).

  • FDA approval (for U.S. devices).

  • TGA approval (for Australian devices).

  • Other relevant approvals based on the device's market history.

• ISO 13485 Certificate for quality management system certification.

• ISO 9001, if applicable.

6. Clinical Evidence

• Clinical evidence is generally not required for Class II devices unless the device poses higher risks or involves novel technology. However, if required:

  • Provide results from clinical trials, clinical studies, or relevant clinical literature.

  • If the device has received regulatory approval in other jurisdictions (e.g., CE, FDA), you may be able to rely on existing clinical data.

• Clinical Evaluation Report (if applicable) showing the clinical safety and effectiveness of the device.

7. Labeling and Instructions for Use

• Device labeling should include:

  • Product name and model number.

  • Manufacturer's name and address.

  • Intended use, indications for use, and contraindications.

  • Warnings, precautions, and limitations of use.

  • Instructions for use (including diagrams, handling, and maintenance guidelines).

• The labels should be in either Chinese or English, or both.

8. Testing and Performance Data

• If the device is subject to specific testing standards (e.g., IEC 60601 for electrical safety or ISO 10993 for biocompatibility), you must provide the relevant test reports or evidence.

  • Electrical safety test results, if applicable.

  • Biocompatibility test results, particularly if the device is intended for patient contact.

  • Performance test results, including any functional testing that supports the device’s safety and effectiveness.

9. Device Design and Development History

• A summary of the design and development process, including:

  • Design changes made during development.

  • Design verification and validation processes to ensure the device meets safety and performance requirements.

• Design Failure Modes and Effect Analysis (FMEA), if applicable.

10. Post-market Surveillance and Vigilance Plan

• A plan outlining the device’s post-market surveillance, including:

  • How the device will be monitored for safety and performance once it is on the market.

  • Adverse event reporting processes.

  • Corrective and preventive actions (CAPA) system in place.

11. Other Supporting Documentation

• Any other documentation that supports the safety, efficacy, and compliance of the device (e.g., third-party assessment reports, audit reports, etc.).

How to Prepare the Application Files:

• Organize Documents: Make sure all documents are well-organized, clearly labeled, and compiled in a logical order.

• Language Requirements: Ensure that all documents are in Chinese or English (depending on the submission requirements).

• Electronic Submission: If applicable, ensure your files are in the appropriate format (e.g., PDF) for electronic submission.

• Hard Copy Submission: If submitting physically, make sure you have printed copies of all required documents, neatly bound or organized for easy review.

By preparing these technical documents meticulously and ensuring that your application is complete and accurate, you will significantly streamline the registration process and improve your chances of a successful Class II MDACS registration.

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