Handling Class A medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) involves following specific steps to ensure compliance with regulatory requirements. Class A devices are considered low-risk, and the registration process is typically more streamlined compared to higher-risk devices. Here’s a step-by-step guide on how to handle the registration process:

1. Confirm Device Classification

• Class A Devices are low-risk medical devices. Before proceeding, confirm that your device qualifies as a Class A device under the MDACS classification guidelines. These devices typically do not pose significant risks and are generally non-invasive.

2. Prepare Required Documentation

Prepare the necessary technical documentation, which typically includes:

• Device Description: Include the intended use and functional specifications of the device.

• Risk Management Documentation: Provide risk assessment reports and strategies to mitigate potential hazards associated with the device (such as in accordance with ISO 14971).

• Compliance with Standards: Ensure the device meets applicable international standards (e.g., ISO 13485 for quality management, ISO 14971 for risk management).

• Labeling and Instructions for Use (IFU): Include product labeling, user manuals, and other information required for the safe and effective use of the device.

• Manufacturer’s Declaration of Conformity: The manufacturer must provide a Declaration of Conformity that attests to compliance with regulatory standards.

• Evidence of Market Authorization in Other Regions (if applicable): If the device is already registered in other regions (such as the EU or the US), provide evidence of market authorization.

• Post-Market Surveillance Plan: Outline how the device will be monitored after it is placed on the market, including processes for reporting adverse events.

3. Submit the Application

• Online Submission: Apply through the MDACS portal or the Hong Kong Department of Health's (DH) online system. You will need to provide the required information, including:

  • Manufacturer’s details (or authorized representative in Hong Kong if the manufacturer is located overseas).

  • Device classification and intended use.

  • Any other required information as per the application form.

• Supporting Documents: Upload all the necessary documents mentioned above in electronic format (e.g., PDFs).

4. Pay Registration Fees

• Fee Payment: Pay the applicable registration fees. The fee will vary depending on the device type and other factors. Payment is typically made online through the MDACS portal, and an invoice will be issued after payment.

5. Review and Evaluation by Hong Kong Department of Health

• Initial Screening: The Department of Health will first verify that all documents are in order.

• Technical Evaluation: The authorities will assess whether the device complies with relevant safety and performance standards.

  • Risk assessment and quality management system (ISO 13485) may be evaluated during this process.

• Request for Additional Information: If any issues are identified, the DH may request clarification or additional documents. Promptly address these requests to avoid delays.

6. Issuance of Registration Certificate

• If the device meets the regulatory requirements and passes the evaluation process, the registration certificate will be issued.

  • You will be provided with a registration number, which should be used in all marketing and sales documentation.

7. Post-Market Surveillance

• Ongoing Compliance: After registration, ensure that the device is compliant with post-market surveillance requirements, including monitoring performance, reporting adverse events, and complying with any regulatory updates.

• Adverse Event Reporting: Be prepared to report any adverse events or product defects to the Hong Kong Department of Health, as required.

8. Periodic Updates

• Re-registration or Renewal: Class A medical devices must typically be re-registered or undergo periodic updates to maintain their registration status. Keep track of the registration validity period and submit necessary updates or renewals as required.

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

1. Confirm Device Classification: Ensure the device is classified as Class A.

2. Prepare Technical Documentation: Include device description, risk management plans, labeling, compliance evidence, and post-market surveillance plans.

3. Submit the Application: Apply through the MDACS portal and submit the required documents and information.

4. Pay Fees: Pay the registration fees through the online system.

5. Review and Evaluation: The Department of Health reviews the application, technical documentation, and compliance with safety standards.

6. Obtain Registration Certificate: If approved, receive the registration certificate and registration number.

7. Post-Market Surveillance: Monitor the device and comply with regulatory reporting requirements.

8. Periodic Updates: Track the registration validity and submit updates as required.

By following this process and ensuring that your device meets the necessary regulatory standards, you can successfully handle the Class A medical device registration under Hong Kong MDACS.

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