To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic medical devices in Hong Kong, you need to follow a series of steps set by the Medical Device Control Office (MDCO) under the Department of Health. Here’s a general outline of the process:

1. Understand the Regulations: Familiarize yourself with the relevant regulations for Class IV in vitro diagnostic devices, which are considered high-risk. You can refer to the Medical Device Ordinance (Cap. 663) and the accompanying guidelines provided by the MDCO.

2. Prepare Documentation: Collect all necessary documents, including:

   • Application form (MDACS application form for Class IV IVD devices).
   • Evidence of compliance with the relevant standards (e.g., ISO 13485).
   • Technical documentation, including device specifications, risk analysis, and clinical data.
   • Labeling and instructions for use.

3. Submit Application: Send your completed application along with the required documents to the MDCO. This can often be done online or via postal mail. Ensure that you provide all requested information to avoid delays.

4. Payment of Fees: Pay the application fee, as specified by the MDCO. Keep a record of the payment.

5. Evaluation Process: After submission, the MDCO will review your application. They may request additional information or clarification during this process.

6. Post-Approval Requirements: Once approved, ensure compliance with post-market surveillance requirements and any conditions imposed by the MDCO. This includes reporting adverse events and maintaining records.

7. Renewal and Updates: Be aware of the need for periodic renewals and updates to your registration, especially if there are changes to the device or relevant regulations.

Additional Tips

• Consult Guidelines: The MDCO provides specific guidelines for IVD devices, so review these for detailed requirements and processes.
• Seek Professional Help: If you're unsure about any part of the process, consider consulting with regulatory experts or professionals who specialize in medical device registrations.

Useful Resources

• Medical Device Control Office (MDCO)
• Guidelines on the Registration of Medical Devices

Always check the MDCO website for the most current information and any updates to the application process.

Contact Us：

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