Hong Kong: Launch of the Webpage “Medical Device Listing Application – Useful Information”

September 12, 2025
Hong Kong, Regulatory Updates

On September 1, 2025, the Medical Device Division (MDD) of Hong Kong launched a new webpage providing useful information regarding the Medical Device Listing Application process.

Scope

Useful information from the Medical Device Division (MDD) regarding the Medical Device Listing Application process.

Key Points

A production license issued by the National Medical Products Administration (NMPA) may be submitted in lieu of an ISO 13485 certificate if the device only holds a registration certificate issued by the NMPA.
The Local Responsible Person (LRP) may enter the previous application number (ANXXXXXX) in field B006 on MDIS if a prior application was unsuccessful.
Device information must be entered directly into MDIS by the LRP. Submission via MDS-01 or MDS-02 forms is no longer accepted.
If no suitable Asian Medical Device Nomenclature System (AMDNS) code is available, the LRP may provide codes from other systems (e.g., Global Medical Device Nomenclature (GMDN)) and indicate which AMDNS codes were attempted.

Labeling Requirements

The submitted labeling must match the version approved in the Marketing Approval. For example, EU-approved devices must display the CE mark.
If multiple marketing approvals are submitted, labeling for each version must be prepared. The LRP must specify which version is marketed in Hong Kong.
Labeling not approved by regulatory authorities (except translations) are not accepted. The LRP must submit both original and translated versions for record purposes.

References

You can access the related guidance documents here:
GN-06: Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices
GN-02: Guidance Notes for Listing Class II, III & IV General Medical Devices

Effective Date

Immediate effect

Implications to Client

Collaborate closely with your Local Responsible Person (LRP) to ensure timely responses to inquiries from the Medical Device Division (MDD) during the review process.
Ensure that GMDN or EMDN codes are available to help identify a suitable AMDNS code for the product.
Make sure that the translated Instructions for Use (IFU) are consistent with the original version approved by the relevant regulatory authorities.

Read the Announcement

You can access the official webpage here: Medical Device Listing Application – Useful Information.

Next Steps

If you are preparing or submitting medical device listings in Hong Kong, our regulatory team can assist you in navigating the Medical Device Division (MDD) requirements, including labeling and nomenclature submissions.