The processes for applying for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) include the following key steps:

1. Determine Device Classification

• Confirm that your device qualifies as a Class II IVD according to MDACS guidelines.

2. Gather Technical Documentation

• Prepare the required technical documents, including:
  • Device description and intended use
  • Labeling and Instructions for Use (IFU)
  • Safety and performance data
  • Risk management documentation (ISO 14971)
  • Quality Management System (QMS) evidence (ISO 13485)
  • Manufacturing and validation information

3. Conduct Clinical Evaluations (if necessary)

• If applicable, perform clinical evaluations or studies to provide evidence of the device's safety and efficacy.

4. Create MDACS Account

• Register for an account on the MDACS online submission platform to facilitate the application process.

5. Complete the Application Form

• Fill out the application form, ensuring all sections are completed accurately and thoroughly.

6. Submit Application

• Submit the application form along with all necessary documentation through the MDACS online system, and pay the applicable registration fee.

7. Initial Review by MDACS

• MDACS conducts an initial review to check the completeness of the application. Be prepared to respond to any requests for missing information.

8. Technical Review and Evaluation

• The application undergoes a detailed technical evaluation by the Department of Health, assessing safety, performance, and compliance with regulations.

9. Respond to Queries

• If MDACS raises any questions or requests further information during the evaluation, respond promptly and comprehensively.

10. Approval and Issuance of Registration Certificate

• If approved, you will receive a registration certificate, allowing you to market the device in Hong Kong.

11. Post-Market Surveillance

• Implement a post-market surveillance plan to monitor the device’s performance and report any adverse events as required.

Summary

The application process for Class II IVD registration in Hong Kong involves determining classification, gathering technical documentation, completing the application form, submitting it online, and undergoing reviews by MDACS. After receiving approval, ongoing post-market surveillance is essential to maintain compliance.

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