Notice: Publication of the 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

November 20, 2017
Our file number: 17-112141-230

Health Canada is pleased to announce the publication of the 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.

The draft version of this guidance document was posted on the Health Canada website from July 31, 2017 until September 29, 2017, for a 60-day consultation. No stakeholder concerns were raised during that time.

This guidance document is effective immediately.

Questions or concerns regarding this guidance document should be directed to:

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

Email: devicelicensing-homologationinstruments@hc-sc.gc.ca
Telephone: 613-957-7285