Consultation on the Draft Guidance Document:  Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing

Consultation on the Draft Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing

This guidance document provides manufacturers of Class IV HIV rapid diagnostic tests intended to be used at the point of care and/or for self-testing (home use) with specific recommendations on: (1) the analytical and clinical data, and (2) device labelling, required to support a medical device licence application.

In May 2017 Health Canada invited feedback from stakeholders on key safety and effectiveness requirements for HIV rapid diagnostic test kits, including whether the need for Canadian investigational testing (i.e. clinical trial) data should be maintained for RDTs. The comments received during the 4-week consultation period were considered when completing this new draft guidance document.

This draft guidance document is the updated and revised version of the 1997 Draft Guidelines for HIV Simple/Rapid Test Kits. It has been updated to allow, where possible, for harmonization of performance requirements with the World Health Organization (WHO) and; other regulators including the United States Food and Drug Administration (USFDA), and to align with the European Common Technical Specifications (CTS).

The main revisions to the original 1997 Guidelines include:

  • The removal of the requirement for Canadian investigational testing (clinical trial) data in support of a medical device licence application;
  • The elimination of the requirement for Canadian seroconversion samples;
  • A decrease in the number of HIV-2 samples that should be tested to support an HIV-2 claim, from 300 to 200;
  • Clarification on the number of non-B subtype positive samples that should be tested;
  • The removal of the need to use a lot close to its expiry date in the clinical studies;
  • Inclusion of sensitivity and specificity requirements for p24 antigen detection;
  • A minimum sensitivity and specificity requirement of ≥99% for HIV RDTs; and
  • Substantial formatting revisions to be consistent with current Health Canada guidance document standards.

Manufacturers of rapid HIV tests wishing to apply for a medical device licence can follow the proposed 2017 draft guidance document, Guidance for Manufacturers of HIV Rapid Diagnostic Tests RDTs for use at the Point of Care or for Self-Testing and are not required to perform trials in Canada as long as the data obtained outside Canada is representative of the Canadian population.

How to Get Involved

This consultation is open for comment until September 29, 2017.

The Draft 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 is available on the Health Canada website.

Health Canada welcomes the participation of all interested parties in this consultation.

For More Information

For general questions, please contact:
Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator:  3002A
Ottawa, Ontario
K1A 0K9

Email: device_licensing@hc-sc.gc.ca
Telephone: 613-957-7285
Fax Number:  613-957-6345

Interested parties are encouraged to provide comments by September 29, 2017.

Reporting to Canadians

A summary of the results from the consultation on the guidance documents will be made available.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: