Hong Kong License Maintenance

Change Notifications

SOME CHANGES NOW REQUIRE PRIOR APPROVAL

On November 30^th, the Hong Kong Medical Device Division (MDD) issued formal guidance (ref. GN-10 Guidance Notes on Changes for Listed Medical Devices, copy available here) on the requirements to maintain compliance when making changes to a medical device registered with the Medical Device Administrative Control System (MDACS). The new guidance will take effect on January 1, 2024.

The GN-10 Guidance document is meant to assist with categorizing (major or minor), managing and reporting changes of listed devices; and includes useful decision flowcharts to help determine what changes fall into what category.

Timelines for Notifying Changes to the MDD

Pursuant to this latest GN-10 Guidance document, some changes can be made without prior notice while other changes will still require prior approval from the MDD.

• Minor changes may be notified within 24 weeks of implementation. The MDD may have questions during their eventual review.
• Major changes must be reported and approved prior to changed devices being imported and sold in the Hong Kong market with a 12-week application processing timeline targeted.

Please click here to read our dedicated blog on the new announcement and changes to Hong Kong’s license maintenance procedures.

Changes That Require a New Registration

The following examples of changes to your product will require a NEW Registration.

1. Significant change to, or additional, Intended Use
2. Significant change to mode of operation

Notice: Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.

Contact Asia Actual to learn more about the license maintenance requirements for your medical device.