Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.
The “For Research Use Only” labeled devices shall be used only in the laboratories during the development phase or for pilot testing and cannot be used either for clinical trial or commercial testing or for sale. The IVD, once it has been validated for performance characteristics, or has a registration application submitted to Health Canada and is under review by Health Canada, or if the IFU (Instructions for Use) claims its performance, it is not considered to be in research phase.
The IVDs intended for commercial testing or clinical trials shall be approved by Health Canada before they are imported and sold in the Canadian market. Since Health Canada carries out the detailed evaluation of safety and efficacy of the IVD, they are reliable for diagnostic purposes.
The manufacturers, importers and distributors of research use only IVDs shall ensure that, the kits are rightly labeled and are used solely for the purpose of laboratory testing. Their use for commercial testing may lead to inaccurate statistics and may adversely impact an individual patient’s health, due to unaddressed health conditions in case of false negative results and unnecessary exposure to medicines in case of false positive results.
The labeling of an IVD as “Research Use Only” is a critical aspect and the devices with such claim are exempted from medical device regulations and are not evaluated by Health Canada. Such devices, when imported into Canada should not be used for clinical trials or clinical diagnosis. In cases where the device eventually gets approval for either clinical trial studies or for commercial testing, the lot imported for “Research Use Only” cannot be distributed for the clinical studies or diagnosis.
Health Canada released the notice, with an aim to facilitate the supply of essential medical devices and IVDs. Hence, the manufacturers, importers and distributors willing to enter the Canadian market are obliged to adhere to the required procedural activities. Consult a regional Regulatory expert for registering your Medical Devices and In-Vitro Diagnostic Devices (IVDs) with Health Canada. Stay informed. Stay compliant.