The process for Class A medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System) is designed to ensure that low-risk medical devices meet the necessary safety and quality standards. Below is an outline of the steps involved in registering a Class A medical device under MDACS:

Step 1: Verify the Classification of the Device

• Class A devices are low-risk medical devices. Before starting the registration process, ensure that the device qualifies as a Class A device according to the MDACS classification criteria.

• Class A devices typically include devices that are simple, have minimal impact on the patient's health, and are not likely to pose significant risks (e.g., bandages, non-invasive diagnostic devices, etc.).

Step 2: Prepare the Necessary Documentation

• Technical Documentation: Prepare detailed technical documentation that demonstrates the device’s compliance with safety, performance, and quality standards. The required documentation typically includes:

  • Product description and intended use.

  • Design and manufacturing specifications.

  • Risk management documentation (e.g., risk analysis, risk control measures).

  • Labeling and Instructions for Use (IFU).

  • Evidence of compliance with international standards (e.g., ISO 13485, ISO 14971).

• Manufacturer Information: If the manufacturer is located outside of Hong Kong, provide details about the manufacturer and the authorized representative (if applicable).

• Post-market surveillance plan: Provide an outline for monitoring the device’s performance once it is on the market, including a system for reporting adverse events.

Step 3: Submit the Application for Registration

• Online Submission: Submit the registration application through the MDACS portal or the Hong Kong Department of Health (DH) online system.

  • The application form should include information such as the device's name, classification, intended use, and details about the manufacturer or the authorized representative.

• Supporting Documents: Submit the technical documentation, including the documents prepared in Step 2. You will likely need to upload the documents in electronic form (PDF or other accepted formats).

• Declaration of Conformity: Submit a Declaration of Conformity from the manufacturer or authorized representative that attests that the device complies with applicable safety and performance standards.

Step 4: Pay the Registration Fee

• Fee Payment: Pay the applicable registration fee based on the device type and other factors. The Hong Kong Department of Health will issue an invoice for the fee.

• Fee Processing: Payment is usually made via the online portal using electronic payment methods. Be sure to retain proof of payment for your records.

Step 5: Review and Evaluation

• Evaluation by Authorities: After submission, the Hong Kong Department of Health (DH) will review the application and technical documentation to assess whether the device complies with Hong Kong's regulatory requirements.

• Inspection or Additional Information: If necessary, the DH may request additional information or documents for clarification. This could include providing further details on the device’s safety, performance, or manufacturing processes.

Step 6: Receive Registration Confirmation

• If the device meets all the necessary requirements and the review is successful, the Hong Kong Department of Health will issue the registration certificate for the Class A device.

• Registration Number: Upon successful registration, a registration number is assigned to the device, which must be used in all marketing and sales documentation.

• Registration Validity: The registration is typically valid for a specific period (often 5 years) before re-registration is required.

Step 7: Market Surveillance and Compliance

• Post-market Requirements: After the device is registered, the manufacturer (or authorized representative) must comply with post-market surveillance requirements, including monitoring the device’s performance and reporting any adverse events or incidents.

• Adverse Event Reporting: If any adverse events related to the device occur, these must be reported to the Hong Kong Department of Health according to the regulatory requirements.

Step 8: Maintain Up-to-Date Registration

• Periodic Updates: The device registration may need periodic updates to ensure continued compliance with any changes in regulations or standards. This could involve submitting new documentation, updating technical files, or providing post-market surveillance data.

• Renewal: If the registration expires, renewal is necessary to continue marketing the device in Hong Kong.

Summary of Steps for Class A Medical Device Registration under MDACS:

1. Verify Device Classification: Confirm that the device qualifies as Class A.

2. Prepare Documentation: Gather technical documentation, including device description, risk management, labeling, and compliance with international standards.

3. Submit the Application: Apply online via the MDACS portal, including necessary documents.

4. Pay Registration Fee: Pay the required fees and retain payment proof.

5. Review and Evaluation: The Hong Kong Department of Health will review the application and request any additional information if needed.

6. Receive Registration Confirmation: If successful, receive the registration certificate and registration number.

7. Post-market Surveillance: Monitor the device’s safety and performance and report adverse events.

8. Periodic Updates and Renewal: Ensure the device remains in compliance with periodic updates and re-registration.

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