Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing

Author: Bhavesh Patel, C. Chem.

In late 2017, Health Canada published a new guidance document concerning HIV RDTs, titled “Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing” (the “Guidance Documents”). The Guidance Document provides manufacturers of Class IV HIV RDTs for point of care or self-testing applications with specific guidance on the analytical and clinical data as well as labelling considerations as part of the device application process. 

In particular, the Guidance Document provide guidance on the labelling requirements set out in sections 21 to 23 of the Medical Devices Regulations and the analytical, clinical and near patient study design and data requirements set out in sections 32(4) (i)(i) and 32(4)(k) of the Regulations. However, other safety and effectiveness considerations, such as process validation, software validation, and literature studies, are not addressed. For further guidance on other safety and effective considerations, sponsors are directed to the Guidance Document “Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications”.

As well, the Guidance Documents does not apply to HIV test kits used for patient management, donor screening or those intended for laboratory use. Instead, sponsors should look to the guidance documents “Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits Intended to be used in the Laboratory” for these products.  

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Reference: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/human-immunodeficiency-virus-rapid-diagnostic-tests-home-use.html#a1.2