To apply for Class II in vitro diagnostic medical device (IVD) registration in Hong Kong through the Medical Device Administrative Control System (MDACS), you will need to follow a series of steps. Here’s a general guide to the process:

1. Understand the Regulatory Framework

• Familiarize yourself with the Medical Device Ordinance (Cap. 663) and the relevant guidelines for IVDs issued by the Department of Health (DH) in Hong Kong.

2. Determine Classification

• Confirm that your device is classified as Class II according to the Hong Kong classification rules for medical devices. Class II devices typically include those with a moderate risk to patients or users.

3. Prepare Documentation

• Compile the necessary documents for your application, including:
  • Device description: Comprehensive details about the IVD, including its intended use and indications.
  • Labeling and Instructions for Use: Product labeling, package inserts, and instructions.
  • Quality Management System: Evidence of compliance with relevant quality standards (e.g., ISO 13485).
  • Safety and Performance Data: Clinical data or studies demonstrating the safety and effectiveness of the device.
  • Risk Management Documentation: A risk analysis report, including any risk mitigation strategies.
  • Manufacturer Information: Details about the manufacturer, including their quality management system and compliance status.

4. Submit Application

• Submit your application through the MDACS portal:
  • Online Submission: You can register and submit your application electronically via the MDACS online system.
  • Application Fee: Pay the applicable registration fee as per the schedule provided on the MDACS website.

5. Await Review and Evaluation

• After submission, your application will undergo evaluation by the relevant authorities. Be prepared to provide additional information or clarifications if requested.

6. Approval and Registration

• Once your application is approved, you will receive a certificate of registration for your Class II IVD. Ensure that you maintain compliance with any post-market surveillance and reporting requirements.

7. Post-Market Obligations

• Adhere to ongoing obligations for maintaining your device's registration, including reporting adverse events, implementing changes, and re-evaluating the device if necessary.

Useful Links

• MDACS Website: MDACS
• Guidelines for Registration of IVDs: Check the MDACS website for specific guidance documents related to IVD registration.

Additional Considerations

• It may be beneficial to consult with regulatory affairs professionals or seek guidance from the Hong Kong Department of Health if you have specific questions or need assistance throughout the process.

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