Hong Kong Proposes Guidelines for In Vitro Diagnostic (IVD) Medical Devices

Currently, Hong Kong has voluntary medical device registration through its Medical Device Administrative Control System (MDACS). The Medical Device Control Office (MDCO) under the Department of Health is planning to expand the MDACS to also include the listing of in-vitro diagnostic medical devices (IVDMD).

IVDMD in Hong Kong would include reagents, calibrators, control materials, etc. They would be classified and controlled according to the risk levels outlined in GHTF document SG1/NO46:2008 Principles of Medical Devices Classification. Therefore, there would be four categories (Classes A to D) with Class A being the category of lowest overall risk and Class D the highest. An example of Class A IVDMD would be a chemical analyzer, while an HIV Blood diagnostic would be an example of a Class D IVDMD. Under the current MDACS, listing of IVDMD Class A devices would not be applicable.

The application procedure would start with the manufacturer designating a Local Responsible Person (LRP). The LRP must be a legal person incorporated in Hong Kong or a natural or legal person with business registration in Hong Kong. The LRP must also be the manufacturer of the device or is supported by the manufacturer to perform the obligations of an LRP for the device. This LRP would then submit an application to the MDCO and then receive approval to be listed in the MDACS. The whole process would take 14 weeks and the listing would be valid for five years. At this point, there would be no government fees.

The application forms are available online at the MDCO website (http://www.mdco.gov.hk) and specify clearly when information in English and/or Chinese is required. In addition to information on the quality systems and product details, applicants must also demonstrate the safety and efficacy of the product by going through an Essential Principles Conformity Checklist.