In Vitro Diagnostic (IVD) Device Registration in Canada and the US

An ‘In Vitro Diagnostic’ device is a medical device or product subject to section 3 of the Medical Device Regulations. These devices are used in vitro for the analysis of specimens derived from the human body. 

If you would like to sell in vitro diagnostic (IVD) devices in Canada, you must first register and obtain a license from Health Canada. Health Canada has a four-tier, risk-based classification system (Class I, Class II, Class III, and Class IV) for IVD products under its jurisdiction.

Thousands of medical device production units and nearly 60% of their imports are coming from the US and other countries. All medical devices marketed in Canada must be compliant with Canadian medical device regulations. To sell IVDs or Class I devices, you need a Health Canada Medical Device Establishment License (MDEL).

However, you can also market your products, through a licensed (MDEL) distributor in Canada. If you are a medical device importer or distributor in the country, you must receive an MDEL irrespective of product classifications.

If you want to commercialize your IVDs in the US market, you need to submit restoration applications to FDA. The FDA submission majorly depends on how your in vitro diagnostic device is classified as per the agency’s classification regulations. Class I, II, and III categories require different FDA registration processes. 

When it comes to IVDs in the US, the review of a 510 (k) includes assessing the analytical performance of the new device. The evaluation is conducted to examine:

1. The inaccuracy or bias of the new device
2. The imprecision of the new device
3. The analytical sensitivity and specificity