What is Class II Medical Device MDACS Registration in Hong Kong?

In Hong Kong, the Medical Device Administrative Control System (MDACS) is a voluntary regulatory system for medical devices. Class II medical devices fall under this system, which is designed to ensure the safety, effectiveness, and quality of medical devices available in the local market.

• Class II medical devices are those that carry a moderate level of risk to the user. They may require some form of intervention to ensure their safety and performance, but they are not as high-risk as Class III devices. Examples of Class II devices might include diagnostic equipment, therapeutic devices, or instruments that require some level of professional oversight.

Under MDACS, medical devices (including Class II) can be voluntarily registered with the Hong Kong Department of Health’s Medical Device Control Office (MDCO). While registration is voluntary, it provides a level of assurance to consumers, health professionals, and regulatory bodies that the device has met appropriate standards for safety and performance.

Why Register a Class II Device Under MDACS?

• Market Access: Registering your medical device under MDACS allows you to legally sell and distribute it in Hong Kong.

• Consumer Confidence: It enhances the credibility and marketability of your device by assuring that it meets safety standards.

• Regulatory Compliance: Registration ensures compliance with local regulations, reducing potential legal and operational risks.

How to Apply for Class II MDACS Registration in Hong Kong?

Here is a step-by-step guide to applying for Class II medical device registration under MDACS:

1. Determine if Your Device is Class II

Before applying, confirm that your device is classified as Class II. The Hong Kong Department of Health (DH) provides guidelines on how to classify devices based on their intended use and risk. If you're unsure, you can consult with MDCO or a regulatory expert to ensure your device classification is correct.

2. Prepare Required Documentation

For Class II device registration, you need to submit various documents as part of your application. Key documents typically include:

• Application Form: Complete the official MDACS application form, which is available from the Department of Health’s website or MDCO.

• Manufacturer Details: Provide information about the device manufacturer, including location, business licenses, and manufacturing practices.

• Product Information:

  • A detailed description of the device, including its intended use, indications, and how it functions.

  • Technical documentation, including product labeling, user manuals, and design specifications.

  • Risk analysis (e.g., ISO 14971 for risk management).

  • Clinical data or other evidence supporting the device’s safety and performance.

  • A certificate of good manufacturing practice (GMP) if applicable.

• Compliance with Standards: Evidence that the device meets relevant international standards, such as ISO 13485 for quality management and ISO 10993 for biocompatibility, if applicable.

• Certificate of Free Sale: If the device is manufactured outside of Hong Kong, you may need to provide a certificate of free sale from the country of origin.

3. Submit Your Application

• You can submit your application through the MDACS platform or directly to the Hong Kong Department of Health (DH).

• If the device is manufactured outside of Hong Kong, you may need to appoint a local authorized representative to handle communications with MDCO.

4. MDCO Review

• The MDCO will review your application, including the supporting documents.

• If your device meets all the required criteria, they will proceed with the registration process.

• MDCO may request additional information or clarification during this stage.

5. Approval and Issuance of Registration

• Once your device is approved, you will receive a registration certificate.

• Your device will be listed in the MDACS database, allowing it to be marketed in Hong Kong.

6. Post-market Surveillance

• After registration, you must comply with post-market surveillance requirements. This includes reporting any adverse events or device recalls to MDCO.

• You must also keep up to date with any changes to regulations that could affect your device’s continued registration.

Key Points to Keep in Mind

• Registration Fee: There is typically a fee for submitting a medical device registration application. Be sure to check the most current fee schedule on the MDCO website.

• Local Authorized Representative: If your company is located outside of Hong Kong, you must designate a local representative in Hong Kong who can handle regulatory matters and communication with MDCO.

• Timeframe: Registration can take a few months, depending on the completeness of your application and the complexity of the device. It’s a good idea to start the process early.

• Voluntary System: MDACS registration is voluntary, but it is a good practice for manufacturers wishing to sell their products in Hong Kong.

Useful Links and Resources

• MDCO Guidelines: Hong Kong Department of Health – Medical Device Control Office

• Application Forms: Available on the official Department of Health website or from MDCO.

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