On 12 June 2026, the Medical Device Division (MDD) of the Hong Kong Department of Health announced revisions to the Listing Application Forms MD101 and MD102 under the Medical Device Administrative Control System (MDACS).
The revised forms will be implemented in the Medical Device Information System (MDIS) effective no earlier than 23:30 HKT on 12 June 2026, together with updates to Guidance Notes GN-02 and GN-06.
Read the full announcement here:
https://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2365.html
Purpose of the Update
To revise the Listing Application Forms MD101 and MD102 under MDACS.
To enhance submission efficiency, strengthen lifecycle transparency, and support innovative medical technologies.
Scope of Application
This update applies to:
- Class II/III/IV general medical devices listed under MDACS
- Class B/C/D IVD medical devices listed under MDACS
- New applications and relevant resubmissions handled by Local Responsible Persons (LRPs)
Key Updates
The key updates include:
Centralised manufacturer and manufacturing site management
A new module will be introduced under Company Profile → Manufacturer Information. Frequently used manufacturer data can be stored and selected from dropdown lists, helping to improve consistency and reduce repetitive data entry.
Auto-population of LRP information and certificate preview
LRP details under B001 will be automatically populated. A certificate preview function will also be available before submission to minimise administrative errors and enhance transparency.
Enhanced contact structure
Multiple contacts can be added as Primary and CC contacts. A reachable local Hong Kong (+852) telephone number is required to strengthen regulatory communication and post-market responsiveness.
New device status declaration
LRPs must declare whether the device is currently listed by another LRP, resubmitted due to closure or withdrawal, or previously listed but expired or delisted. This supports better lifecycle traceability and regulatory oversight.
Autofill function for Part C from past applications
Previous Application Numbers can be selected, and fields C002 to C017 can be automatically populated. This improves efficiency and reduces submission errors.
Innovative medical device declaration
A new section allows applicants to identify devices eligible for “Innovative MD” priority consideration. This may include first-of-its-kind devices, devices approved through innovation pathways, AI-enabled devices approved within five years, and devices with patented core technology.
Integration of Hospital Authority procurement information
MD111e is now embedded in the application form. Applicants are required to provide Hospital Authority procurement information, including purchase order number, date, and supplier.
Added compliance declaration
Applicants must also declare compliance with the Prevention of Bribery Ordinance (Cap. 201).
Implications to Client
This update indicates that Hong Kong is moving toward a more structured, digitalised, and innovation-oriented regulatory system.
Clients should note that:
- Medical device listing applications already submitted or listed via MDIS will not be affected by this change.
- Applicants do not need to resubmit existing applications.
- Applicants should evaluate whether their devices may be eligible for the “Innovative MD” designation.
- LRPs should strengthen local contact readiness and regulatory responsiveness.
References
Read to learn more:
- [GN-06] Guidance Notes for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices
- [GN-02] Guidance Notes for Listing Class II/III/IV Medical Devices
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com.