Here are the eligibility criteria to apply for Class B medical device registration under the Hong Kong MDACS:

Eligibility Criteria for Class B Medical Device Registration under Hong Kong MDACS

1. Device Classification

   • The medical device must be correctly classified as Class B (low-to-medium risk) according to the MDACS classification rules.

   • Classification is based on intended use, risk level, and device characteristics defined by the Hong Kong Department of Health.

2. Local Responsible Person (LRP)

   • The applicant must appoint a Local Responsible Person (LRP) based in Hong Kong.

   • The LRP must be a legal entity registered or incorporated in Hong Kong.

   • The manufacturer (if overseas) must issue a valid authorization letter granting the LRP authority to act on its behalf.

3. Manufacturer Compliance

   • The device manufacturer should have a Quality Management System (QMS) certified to ISO 13485 or equivalent.

   • The device should meet applicable safety and performance standards (e.g., IEC, ISO).

   • Preferably, the device should have approval or certification in recognized reference markets (e.g., CE marking, FDA clearance).

4. Document Availability

   • The applicant must be able to provide the necessary technical documentation, including risk management files, labeling, clinical/performance data (if applicable), and certificates.

5. Intended Use

   • The device must be intended for medical purposes as defined by MDACS regulations.

Summary

If your device and your company meet these criteria, you can proceed with preparing and submitting the registration application under MDACS.

Would you like guidance on how to verify your device classification or how to draft the LRP authorization letter?

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