Hong Kong IVD Registration
IVD registration in Hong Kong, also known as “Listing”, is voluntary under the Medical Device Administrative Control System (MDACS).
Managed by the Medical Device Division (MDD) of the Department of Health, MDACS facilitates pre-market control of medical devices, including IVDs.
Though voluntary, IVD listing is strongly encouraged for procurement purposes by public hospitals, clinics, and the Hospital Authority.
How to List an IVD in Hong Kong
To list an IVD under MDACS, the manufacturer (foreign or local) must appoint a Local Responsible Person (LRP) and submit a registration application to the MDD with:
How to List an IVD in Hong Kong
To list an IVD under MDACS, the manufacturer (foreign or local) must appoint a Local Responsible Person (LRP) and submit a registration application to the MDD with:
IVD Conformity Assessment Requirements
The IVD must conform to the Technical Reference TR-005, which outlines the Essential Principles of Safety and Performance specific to IVDs. Depending on the classification, the MDD may request clinical performance data and additional documentation during review. The Conformity Assessment Body (CAB) evaluates whether the product meets these standards.
IVD Risk Classification in Hong Kong
Under the MDACS, Hong Kong applies the IMDRF IVD classification system, dividing IVDs into Classes A, B, C, and D based on risk. Only Classes B, C, and D are eligible for listing under the MDACS, similar to the classification of medical devices in Classes II, III and IV.
The level of regulatory control increases as the risk classification of the devices rises, aligning with international guidelines to ensure compliance during the device registration process.
Why List Your IVD Device in Hong Kong?
China Greater Bay Area Connect Scheme for IVDs
The GBA Connect Scheme allows IVD devices without prior approval in China but with reference-country listings to be used in designated GBA hospitals. As of February 2025, 45 hospitals are included in the scheme. Hong Kong listing is a key stepping stone for manufacturers targeting the GBA and mainland China markets.
Our Hong Kong IVD Listing Services
We offer end-to-end support for IVD registration or listing in Hong Kong:
- Hong Kong MDACS Listing
- GBA Connect applications
- Expedited approval routes where eligible
Request a Proposal to List Your IVDs in Hong Kong
Let Cisema help turn your plans into reality.
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