Understand the voluntary framework
The Department of Health’s Medical Device Division describes MDACS as a voluntary administrative system, including device and trader listing and adverse-event reporting. It should not be described as universal mandatory medical-device registration. Check current official guidance when planning a particular product’s entry.
Assess listing and procurement separately
Where MDACS listing is pursued, assess the Local Responsible Person’s eligibility, designation and responsibilities. Separately, check the requirements of the intended hospital or purchaser. A procurement condition may be important commercially without being a universal legal market-entry requirement.
Review other applicable rules
The Medical Device Division notes that some products may be regulated by other legislation, depending on their nature and characteristics, including rules relating to pharmaceuticals, radiation and telecommunications. We recommend a product-specific review and a documented post-market monitoring plan.
Official sources
Hong Kong Medical Device Division — Frequently Asked Questions ↗Sources accessed on 14 November 2026. Planning recommendations are identified in the text. Requirements may change; confirm the current position with the relevant authority.