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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 require separate approval under the Radiation Ordinance and are subject to additional inspection and licensing. Submit MDACS applications and Radiation Ordinance applications concurrently; processing timelines are independent. Consult the Radiation Protection Bureau for specific requirements.