On April 01, 2026, the Medical Device Division (MDD) issued Technical Reference TR-010: Combination Products. TR-010 provides clarification, supported with examples, on the applicability of combination products under the Hong Kong Medical Device Administrative Control System (MDACS).
In the context of the MDACS framework, combination products are generally described as products composed of a medical device integrally combined with one or more non-device components, as outlined in the document.’
Read the full update here:
https://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2360.html
Purpose of the Technical Reference
- To provide clarification on the applicability of combination products under the Medical Device Administrative Control System (MDACS).
- To establish key principles for determining whether a combination product falls within the scope of MDACS.
Scope of Application
This Technical Reference applies to manufacturers and Local Responsible Persons (LRPs) assessing whether combination products fall within the scope of the Medical Device Administrative Control System (MDACS).
Key Highlights
- TR-010 elaborates on Clause 3.2 of Guidance Notes GN-01.
- Establishes key principles for determining whether a combination product falls within the scope of MDACS.
- Provides illustrative examples of combination products considered within and outside the scope of MDACS.
- Emphasizes that eligibility for MDACS listing of certain combination products is assessed on a case-by-case basis.
- Assessment takes into account relevant product characteristics.
References
GN‑01: Overview of the Medical Device Administrative Control System
Implications to Clients
- TR-010 provides technical clarification to support case-by-case determination of whether a combination product falls within the scope of MDACS.
- Manufacturers and Local Responsible Persons (LRPs) are advised to refer to this technical document when assessing MDACS applicability for combination products.
Effective Date
Immediate
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com