To apply for Class II medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you need to follow a series of steps to ensure compliance with the local regulations. Here's a general overview of the process:

1. Determine Device Classification

• Ensure that your device is classified correctly as Class II. This can typically be done based on the device’s intended use and level of risk. If you’re uncertain about the classification, consult the Guideline on the Classification of Medical Devices provided by the Hong Kong Medical Device Control Office (MDCO).

2. Prepare Required Documentation

For Class II devices, you will generally need to provide the following documents:

• Application Form (available from MDCO)

• Manufacturer Information:

  • Company details and certificate of good manufacturing practice (GMP), if applicable.

  • If the device is manufactured outside Hong Kong, provide a Certificate of Free Sale from the country of manufacture.

• Product Information:

  • A description of the device, its intended use, and its clinical indications.

  • Technical documentation, including a device manual, product specifications, and labeling.

• Risk Assessment: Demonstrate the risk classification and a clinical evaluation of the device if needed.

• Standards Compliance: Evidence of compliance with applicable international standards (ISO, IEC, etc.), including the quality management system (e.g., ISO 13485).

• Pre-market Clinical Data (if applicable): Clinical performance data that supports the safety and effectiveness of the device.

3. Submit Application

• Submit the completed application and all supporting documents to the Hong Kong Department of Health (DH) through the MDACS platform or as directed by the department.

• Ensure the documentation is in English or Chinese, as required.

4. MDACS Review

• The MDCO will review the submitted documents for compliance with regulatory standards and requirements.

• If necessary, MDCO may request additional information or clarification from the applicant.

5. Approval and Registration

• Upon successful evaluation, the medical device will be registered under the MDACS. You will receive a registration certificate for the Class II device.

• MDCO will list the registered device in the MDACS database, allowing it to be marketed and sold in Hong Kong.

6. Post-market Surveillance

• After registration, maintain post-market vigilance and report any adverse events, complaints, or device recalls to MDCO in accordance with Hong Kong regulations.

Key Points to Remember:

• Registration Fees: There are registration fees based on the class of the device, so be sure to confirm the latest fee schedule.

• Local Authorized Representative: If your company is located outside Hong Kong, you must appoint a local authorized representative who will act as a liaison with MDCO.

• Timeframe: Registration processing times can vary, so allow sufficient time for review and approval. It can take a few months depending on the complexity of the submission.

For more detailed information, refer to the MDCO’s guidelines and the official Hong Kong Department of Health website or contact the MDCO directly for guidance on the specifics of your product.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn