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

Get help from our US regulatory experts to submit your application for In Vitro Diagnostic Devices  (IVD) devices or file a Premarket Notification with the FDA, also known as an FDA 510(k)

IVD Devices and Registration in Canada

An IVD or ‘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 medical device license from Health Canada. Health Canada has a four-tier, risk-based classification system (Class I, Class II, Class III, and Class IV) for medical devices in Canada.

ICD products
IVD medical device

Importance of IVD Devices

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.

IVD Device 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 and regulatory compliance.

ICD products

We will determine if your activities will require an MDEL.

We will help you obtain Health Canada approval.

Our specialists will help you stay compliant with Health Canada’s medical device regulations.

IVD Device 510(k) Registration in the US

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

FDA Submission for In Vitro Diagnostic (IVD) Devices in the US

If you want to commercialize your IVDs in the US market, you need to submit an application to the FDA. The FDA submission majorly depends on how your IVD 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

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.
IVD medical device

Frequently Asked Questions

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

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