MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong

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 Making Changes to Hong Kong Licenses

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.

Key points in the guidance document include:

1. Changes to the QMS system, design, sterilization, software, materials, and labeling are covered.
2. Only one Major change application will be processed at one time.
3. Rules for the supply of original and changed product versions are outlined.
4. Failure to comply may result in de-listing from MDACS.

New Regulatory Challenges

Because registering a medical device for listing in MDACS is voluntary, it is possible to supply original and changed medical devices at the same time. The Local Responsible Person (license holder) must submit a schedule of concurrent supply as part of the Change Application and mechanisms are in place to distinguish between original and changed devices.

Caution: Listings in the MDACS that are not maintained for compliance may face delays and negative repercussions during license renewal (due every 5 years).

What is Considered a Major Change?

Given the new notification requirements, it will be crucial for manufacturers and their local LRP (license holder) to correctly assess whether the change is classified as a minor or a major change. Per Section 2 of the GN-10 Guidance document, the MDD provides the following language:

2.1 Major Change means a change that could be expected to affect the safety, quality or performance (SQP) of a medical device.

2.1.1 A Major Change typically may:

(a) result in risks to the patient not previously identified

(b) increase the probability of existing hazards occurring

(c) alter the presentation of existing or new risks to the user (may involve labelling changes or new indications for use)