In Vitro Diagnostic (IVD) Devices Registration in Canada and US

Get professional help in registering and obtaining In Vitro Diagnostic (IVD) Medical Device License (MDL) from Health Canada as well as get assistance in In Vitro Diagnostic Device 510(k) Registration in US.

In Vitro Diagnostic Devices and Registration in Canada

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.

Importance of In Vitro Diagnostic Devices Registration

Thousands of medical device production units and nearly 60% of their imports are coming from 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.

In Vitro Diagnostic Devices Registration Consulting Services

With more than a decade of experience in IVD device registration, we offer you complete solutions.

Our experts will determine if your product is an IVD device.

We will assist in completing and submitting the application form.

We’ll help you on issues related to quality assurance, regulatory compliance.

We will determine if your activities will require an MDEL.

We will help you obtain health Canada regulatory approval.

Our specialists will support you in compliance with Health Canada regulations.

In Vitro Diagnostic Device 510(k) Registration in US

Get help from FDA experts in US to submit your application for In Vitro Diagnostic Device 510 (K) or file a Premarket Notification with the FDA, also known as an FDA 510(k). 

FDA Submission for In Vitro Diagnostics (IVDs) Devices in US

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. 

510(k) Review Process for IVD devices in US

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 the:

  1. the inaccuracy or bias of the new device;
  2. the imprecision of the new device;
  3. the analytical sensitivity and specificity.
Need Support for In Vitro Diagnostic Devices (IVD) Registration in Canada and US?

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest