To apply for and register a Class A medical device under Hong Kong's Medical Device Administrative Control System (MDACS), you need to follow specific steps. The process is streamlined for low-risk devices like Class A, but it still involves meeting key regulatory requirements. Below is a detailed guide on how to apply for and register a Class A medical device under MDACS:

Step-by-Step Guide for Class A Medical Device Registration under Hong Kong MDACS

1. Confirm Device Classification

• Class A Device Definition: Ensure that your device qualifies as Class A under MDACS classification. Class A devices are considered low-risk and generally include non-invasive devices that do not present significant harm to patients or users.

• Verify Device Type: Common Class A devices include items like bandages, non-invasive thermometers, and other low-risk medical devices.

2. Prepare Required Documentation

You need to prepare several key documents to support your application for Class A registration. These include:

• Device Description: Detailed information on the device, including its intended purpose, key features, and how it functions.

• Risk Management Documentation: Risk assessment following ISO 14971, a standard that outlines how to manage the risks associated with medical devices.

• Compliance with Standards: Evidence of compliance with relevant international standards such as ISO 13485 for quality management systems and ISO 14971 for risk management.

• Labeling and Instructions for Use (IFU): Include a copy of the device's labeling and the instructions for use, including safety warnings and intended applications.

• Manufacturer's Declaration of Conformity: A statement from the manufacturer or authorized representative confirming that the device meets all regulatory standards.

• Post-Market Surveillance Plan: Details of how the device will be monitored once on the market, including mechanisms for reporting adverse events or device failures.

3. Create an Account on MDACS Portal

• Access MDACS Portal: To begin the application process, you must register an account on the MDACS online portal.

• Submit Application Online: After creating an account, log in to the MDACS portal to submit your registration application for the Class A device.

4. Fill Out the Application Form

• Provide Manufacturer Details: The application requires information about the manufacturer or the authorized representative in Hong Kong (if the manufacturer is based overseas).

• Device Classification: Specify the classification of your device (Class A) and provide a description of the intended use of the device.

• Upload Supporting Documents: Upload the required technical documentation and compliance documents, such as the device description, risk management plan, ISO certifications, and any other regulatory documents.

5. Pay Registration Fees

• Fee Payment: You must pay the applicable registration fee. The fee for Class A medical device registration in Hong Kong is relatively lower compared to higher-risk devices.

• Online Payment: Pay the registration fees through the MDACS online system using available payment methods.

• Receipt and Invoice: After payment, you will receive a confirmation of the transaction and an invoice for the payment.

6. Application Review

• Initial Screening: The Hong Kong Department of Health (DH) will perform an initial check to verify that all required documentation is included and that the application is complete.

• Technical Evaluation: The application will undergo technical evaluation to ensure that the device meets the required safety, performance, and regulatory standards.

  • During this process, the Department of Health may request additional information or clarification if there are any discrepancies in the application.

• Approval or Request for Additional Information: If the Department of Health finds the application satisfactory, they will approve the registration. If they require more information, you will be notified to provide the requested details.

7. Receive Registration Certificate

• Registration Confirmation: If the application is approved, you will receive a registration certificate for the Class A medical device.

• Registration Number: The certificate will include a registration number that must be used in all marketing and distribution materials associated with the device.

8. Post-Market Surveillance and Compliance

• Ongoing Monitoring: Once registered, you are responsible for ensuring the device’s ongoing safety and performance. You must implement post-market surveillance mechanisms to track the device’s performance once it is available on the market.

• Adverse Event Reporting: If any adverse events occur, such as device failures or safety incidents, these must be reported to the Hong Kong Department of Health.

• Periodic Updates: The registration may require periodic updates or renewals to ensure the device remains compliant with regulatory changes or safety standards.

9. Keep Track of Registration Period

• Validity Period: Class A medical device registration under MDACS is valid for a period of time (usually 5 years). You should track the registration period and submit a renewal or update if necessary to keep the registration valid.

Key Points to Remember:

1. Document Preparation: Ensure that you have all the required technical documentation, including risk assessments, labeling, and compliance certificates.

2. Online Application: All applications must be submitted through the MDACS portal.

3. Fee Payment: Pay the registration fees as per the MDACS guidelines.

4. Compliance with Standards: Ensure the device complies with international standards such as ISO 13485 (for quality management systems) and ISO 14971 (for risk management).

5. Post-Market Surveillance: Implement a plan to monitor the device once it's on the market, including the ability to report adverse events.

Summary of the Application Process:

1. Confirm the device is a Class A medical device.

2. Prepare required documentation, including device description, risk management, labeling, and post-market surveillance plans.

3. Submit the application online via the MDACS portal.

4. Pay the registration fee.

5. Wait for the review and approval from the Department of Health.

6. Receive the registration certificate and registration number.

7. Follow post-market surveillance requirements to monitor device safety and performance.

By following these steps carefully, you can successfully apply for and register a Class A medical device under Hong Kong’s MDACS.

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