Here’s a clear outline of the application procedures for Class B medical device MDACS registration in Hong Kong:

Application Procedures for Class B Medical Device MDACS Registration

1. Confirm Device Classification

• Verify that your device falls under Class B based on MDACS classification rules.

2. Appoint a Local Responsible Person (LRP)

• Must be a person or entity based in Hong Kong.

• Acts as your official regulatory contact with the Medical Device Division (MDD).

3. Prepare Application Documents

• Complete Form MD1 (Device Listing Application).

• Compile technical documentation including:

  • Device description and specifications

  • Labeling and Instructions for Use (IFU)

  • Risk management documentation

  • Quality Management System (ISO 13485) certificate

  • Evidence of approval from recognized markets (e.g., CE mark, FDA clearance)

• Letter of Appointment of LRP.

• Proof of payment of application fee (HK$500 per device).

4. Submit Application

• Submit the complete application package to the Medical Device Division, Department of Health, Hong Kong.

• Submission can be made by:

  • Mail: Address to Medical Device Division, Department of Health

  • In-person: At the Department of Health office.

5. Pay Application Fee

• Pay HK$500 for each device listed.

• Include payment receipt with your application.

6. Application Screening

• MDD performs an initial check for completeness.

• May request additional information if required.

7. Technical Review

• MDD reviews all documentation for compliance with essential principles.

• Verifies safety, performance, labeling, and reference market approvals.

8. Respond to Queries

• Address any questions or requests from MDD promptly to avoid delays.

9. Receive Registration Approval

• If approved, MDD issues a device listing number.

• You are authorized to market the Class B device in Hong Kong.

10. Post-Registration Requirements

• Maintain post-market surveillance.

• Report adverse events or changes to MDD.

• Update registration information as necessary.

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