Skip to main content

Legislative Framework

HK-unique · No standalone Medical Device Ordinance (yet)

No Standalone Medical Device Ordinance​

Hong Kong is one of the few developed markets without a dedicated medical device law. MDACS operates administratively. Applicable ordinances include:

Pharmacy and Poisons Ordinance (Cap. 138)​

Regulates pharmaceuticals. Relevant for borderline device-drug products.

Radiation Ordinance (Cap. 303)​

Governs radiation-emitting devices (X-ray, radiation therapy, nuclear medicine). Required in addition to MDACS for radiation devices.

Public Health and Municipal Services Ordinance (Cap. 132)​

Certain provisions affect the supply of medical products to the public.

Proposed Medical Devices Ordinance​

Consultation has occurred on a statutory framework. If enacted, listing would become legally mandatory. See Reform Outlook.

Radiation Devices — Dual Approval Pathway

Devices that emit ionizing or non-ionizing radiation (X-ray equipment, ultrasound, laser, radioactive sources) require approval under both MDACS and the Radiation Ordinance (Cap. 303):