You can apply for the Class I medical device listing under Hong Kong's Medical Device Administrative Control System (MDACS) through the Medical Device Information System (MDIS), the official online platform provided by the Hong Kong Department of Health.

🖥️ Apply via the MDIS Portal

• Website: https://mdis.mdd.gov.hk

The MDIS platform allows you to:

• Submit online applications for listing medical devices and traders under MDACS.

• Report safety alerts and adverse events related to medical devices.mdd.gov.hk+2mdd.gov.hk+2mdd.gov.hk+2

• Access forms and guidance notes for various application processes.

📄 Required Documentation

When applying for a Class I medical device listing, ensure you have the following documents:

• Device Description: Detailed information about the medical device, including its name, intended use, model, and design.

• Manufacturing Information: Details about the device's manufacturer, including the address and processes involved in manufacturing the device.

• Conformity to Safety and Performance Requirements: Evidence that the device complies with relevant safety and performance standards. This can include:

  • Declaration of Conformity to international standards (e.g., ISO 13485).

  • CE Mark certification or similar regulatory approvals (e.g., FDA clearance).

• Labeling Information: Details about the labeling of the device, including instructions for use, warnings, manufacturer's name and address, and any relevant regulatory marks (e.g., CE or FDA mark).

• Risk Assessment: For Class I devices, the risk is usually minimal, but a basic risk analysis should be provided to support the classification.

📌 Additional Notes

• Local Responsible Person (LRP): If you're an overseas manufacturer, appointing a Local Responsible Person in Hong Kong is mandatory. The LRP will handle the registration process on your behalf.

• Online Submission: All applications must be submitted through the MDIS platform, making it a centralized and digital process.

• Processing Time: The Hong Kong Department of Health aims to process Class I medical device applications within 12 weeks from the submission date, assuming all required documentation is complete and accurate.

For more detailed information and to start your application, visit the official MDACS website: MDACS Listing Application.

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