Here’s the detailed application process for Class B medical device registration under the Hong Kong MDACS:

Application Process for Class B Medical Device Registration under Hong Kong MDACS

Step 1: Confirm Device Classification

• Verify that your medical device is classified as Class B based on Hong Kong’s MDACS risk classification system.

Step 2: Appoint a Local Responsible Person (LRP)

• Assign an LRP with a valid Hong Kong address to act as your official contact for regulatory matters.

Step 3: Prepare Application Documents

• Gather all required documents, including:

  • Completed application form

  • Product description and specifications

  • Safety and performance test reports

  • Risk management documentation

  • Labelling and instructions for use in English or Traditional Chinese

  • Quality management system certificate (e.g., ISO 13485)

  • Copies of relevant certificates from other regulatory authorities (if available)

Step 4: Submit Application

• Submit the application form and supporting documents to the Medical Device Division (MDD) of the Hong Kong Department of Health.

• Submission can be done by mail or in person at the MDD office.

Step 5: Pay Application Fee

• Pay the prescribed fee as per the MDACS fee schedule.

• Keep the payment receipt for reference.

Step 6: Application Review by MDD

• The Medical Device Division conducts an initial completeness check.

• Then performs a technical evaluation of submitted documents.

• If necessary, the MDD may request additional information or clarifications.

Step 7: Receive Registration Confirmation

• After successful review and approval, the applicant receives an official registration confirmation letter along with a registration number.

Step 8: Maintain Post-Registration Compliance

• Continue to comply with post-market surveillance, adverse event reporting, and any other ongoing regulatory obligations.

Summary Flowchart

If you want, I can help review your documents or guide you through any of these steps. Would you like support with that?

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