​​How to register an in vitro Diagnostic Device (IVDD) in Canada​ 

This white paper highlights the key requirements to register in vitro diagnostic devices in Canada.

What is an in vitro diagnostic device?
Who regulates in vitro diagnostic devices?
What is the process for registering in vitro diagnostic devices in Canada?  

 

What is an In Vitro Diagnostic device?

In vitro diagnostic devices (IVDD) form a sub-category of medical devices that is intended to be used for the in vitro examination of specimens taken from the body1.

Whilst the formal definition is short, it applies to reagents, articles, instruments, apparatus, equipment or systems, including calibrators, control materials, software, manufactured, sold or represented for in vitro diagnostic use and encompasses all applications such as screening, diagnosis, monitoring, prognosis, predisposition and prediction2.

This includes ‘near patient IVDDs’ which are used outside a laboratory and include testing at home or at the point of care, such as a pharmacy, a health care professional’s office or at the patient’s bedside1.

What is not an IVDD?

Products that are not regulated as IVDDs are products such as reagents, instruments, apparatus, equipment or systems that are not manufactured, sold or represented by manufacturers for use in in vitro diagnostic applications. Any products labelled ‘For Research Use Only’ are also not regulated as IVDDs.

Who regulates IVDDs in Canada?

The Health Products and Food Branch (HPFB, otherwise known as Health Canada) regulates all therapeutic goods, including IVDDs in Canada. Health Canada’s role is to regulate and monitor all therapeutic goods to ensure that they are safe to use and do what they are intended to do, as mandated by the Food and Drugs Act 1985. Health Canada is part of the Canadian Government.

How are IVDDs regulated in Canada?

Health Canada have established a risk rule-based classification scheme for IVDDs, i.e. the classification will depend on the level of risk the device poses to public health or individual personal risk (definitions are provided in Table 1 below). It includes risk indicators such as:

  • expertise of the intended user (i.e. testing laboratory vs self-testing)
  • importance of the information to the diagnosis
  • nature of the disease, mode and efficacy of transmission.

Table 1: Risk definitions for public health and the individual2 

RiskRisk Definition
High public health riskRefers to IVDDs used for donor screening or for the diagnosis of life-threatening diseases. These are diseases that result in death or long-term disability, that are often untreatable or require major therapeutic interventions and where an accurate diagnosis is vital to mitigate the public health impact of the condition.
Moderate public health riskRefers to IVDDs that are used to detect transmissible agents that cause diseases that, although often treatable, may result in death or long-term disability if not treated in a timely manner and where an accurate diagnosis offers an opportunity to mitigate the public health impact of the condition.
Low public health riskRefers to IVDDs for example that detect infectious agents which are not easily propagated in a population or that cause self-limiting diseases.
High individual riskRefers to IVDDs where an erroneous result would put the patient in an imminent life-threatening situation or would have a major negative impact as they are a critical, or even the sole, determinant of a diagnosis or treatment decision.
Moderate individual riskRefers to IVDDs whose use are not the sole determinant of a diagnosis or treatment decision and where they are, it is not likely that an erroneous result will cause death, severe disability, or other major negative health impact.

The classifications related to the level of risk, together with examples is provided in Table 2 below.

Table 2: Risk based classification system2 

ClassLevel of RiskDevice Example
IMinimal public health risk or minimal individual health risk General in vitro diagnostic laboratory equipment or general diagnostic reagents 
IILow public health risk or moderate individual risk Pregnancy self-testing kits 
Test to detect Infleunza B 
IIIModerate public health risk or high individual risk Tests to detect sexually transmitted agents 
Tests used to detect septicaemia 
IVHigh public health risk Tests used for donor screening 
Test to diagnose HIV

There are 9 classification rules. The rules are shown in Table 3 below. 

Table 3: Classification rules of IVDDs2 

Rule Number Description 
1IVDDs used for donor screening 
2IVDDs used to determine disease status or immune status 
3IVDDs used for patient management purposes 
4IVDDs used for disease status and for patient management 
5IVDDs for immunological typing 
6Near-patient IVDDs 
7IVDDs specifically intended to be used together 
8Class I IVDDs 
9Special classification 

For import, sale and supply into Canada all IVDDs require a Licence. Licencing is determined by who/how the device is sold (discussed in the next section) and the classification of the device where: 

  • Class I devices require a Medical Device Establishment Licence (MDEL). 
  • Class II to IV devices require a Medical Device Licence (MDL). 

All IVDDs are required to comply with: 

  • safety and effectiveness requirements 
  • labelling requirements 
  • distribution records 
  • complaint handling 
  • mandatory problem reporting 
  • recall requirements. 

Who is responsible for IVDDs? 

There are three important roles – the manufacturer, importer and distributor (refer to Table 4 below for their responsibilities). These roles alongside the classification of the IVDD, determine whether an MDEL or MDL is required or not. For example, a distributor outside of Canada selling IVDDs exclusively to healthcare facilities in Canada, without the distributors name on the label requires an MDEL3

Table 4: Responsibilities for manufacturers, importers and distributors1 

RoleResponsibilities
Manufacturer Sells an IVDD under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the IVDD, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. 
Importers Canadian-based companies (other than the manufacturer) responsible for bringing the IVDDs into Canada for sale. 
Distributor Companies (other than the manufacturer or importer) either within or outside of Canada that sell IVDDs in Canada for the purpose of resale or use. 

What’s needed to obtain a Medical Device Establishment Licence? 

To obtain a MDEL for a Class I IVDD, submission of the MDEL Application form that includes the following items it required3

  • Establishment details. 
  • Manufacturer details. 
  • Classification of the IVDDs to be imported or distributed. 
  • Attestation signed by a senior official affirming that the establishment possesses the required documented procedures. 

What’s needed to obtain a Medical Device Licence? 

To obtain an MDL for Classes II-IV IVDDs, the following is required to be submitted for Health Canada screening4

  1. MDL Application Form 
  2. Intended Purpose 
  3. Fee Form 
  4. Quality Management System Certificate
  5. Labelling
  6. Premarket Review Document. 

Further information on each of the above components if provided below: 

Intended Purpose

The manufacturer determines the intended purpose of the IVDD. It informs the classification rule that will be applied. The intended purposes of an IVDD primarily describes: 

  • ‘What’ the IVDD does (i.e. predict, monitor, etc). 
  • ‘Who’ is using the IVDD (i.e. public versus health practitioner). 

Quality Management System Certificate 

The quality management system certificate accepted by Health Canada is known as a Medical Device Single Audit Program (MDSAP) certificate. 

The MDSAP involves certification to ISO 13485 as well as the regulatory requirements to the participating countries, namely, the United States of America (USA), Australia, Canada, Japan and Brazil. 

Labelling

Labelling includes the label attached to the IVDD and the Directions for Use. Both must include the name and an identifier of the IVDD (i.e. model number of the IVDD).  

The label must also include a ‘control number’, otherwise known as a serial, lot, or batch number.  

The Directions for Use must include all of the required instructions for the user to use the IVDD safely and effectively. 

Premarket Review Document 

The premarket review document contains information to demonstrate the safety and effectiveness of the medical device. For a Class II IVDD this involves an attestation that they have evidence to support the applicable Safety and Effectiveness Requirements5. Similar to TGA’s Essential Principles (EP) Checklist or the EU’s General Safety and Performance Requirements (GSPR) Checklist, a manufacturer can demonstrate compliance with the requirements by complying with a recognised standard and provide supporting evidence. Examples of standards that can be used to demonstrate compliance with the safety and effectiveness requirements include: 

  • ISO 14971 – Application of risk management to medical devices. 
  • ISO 11137 – Sterilisation of health care products – Radiation. 
  • CLSI EP-25–A2 – Evaluation of stability of in vitro diagnostic reagents; Approved Guideline. 

Examples of supporting evidence that can be used are: 

  • a documented risk analysis 
  • the document for the manufacturer’s testing results 
  • specific relevant documentation for IVD devices (e.g. specimen type and collection method, reagent description, assay procedure, clinical evidence) 
  • copies of labels, packaging and Directions for Use that indicate compliance with relevant requirements and standards 
  • clinical evidence, from clinical trials and/or a documented review of appropriate published literature, compiled by a relevant clinical expert. 

For a Class III and Class IV IVDDs the evidence to support the applicable Safety and Effectiveness Requirements must be submitted for pre-market screening by Health Canada.  

Fees and Timelines 

Upon submitting an application for screening by Health Canada, it will undergo an administrative screening process within 4 calendar days, to validate the administrative completeness. The applicant will receive a notification upon successful completion of this stage. If not approved, the manufacturer has 10 calendar days to provide the necessary information. Upon successful completion, the application fee is charged, and the review process begins4. A list of fees, their description and legislated review timeline are provided in Table 5 below. 

Table 5: Explanation of Fees^ 

FeeFee DescriptionTimeline
MDEL Fee Fee to apply for an MDEL and renew annually are the same. 120 calendar days 
MDL Fee Fee to apply for an MDL Class II: 15 calendar days 
Class III: 60 calendar days 
Class IV: 75 calendar days 
Right to Sell Fee Annual fee to maintain MDL 

^Note: fees are increased every year from the 1st April. Refer to the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html) for current fees and charges for medical devices. 

Useful Links 

Health Canada
Medical Devices Active Licence Listing (MDALL)
Medical Devices Establishment Licence (MDEL) Listing
International Medical Device Regulators Forum (IMDRF) | International Medical Device Regulators Forum
GMDN Agency 
MDSAP 
Food and Drugs Act 1985
Medical Devices Regulations (SOR/98-282) 

Resources

1Health Canada, Medical Devices Regulations SOR/98-282, Current to 31st December 2023, https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/index.html, accessed 2nd February 2024.
2Health Canada, Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs), Date modified: 7th October 2016, https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html, accessed 2nd February 2024.
3Health Canada, Guidance on Medical Device Establishment Licensing (MDEL), date issued 1st April 2020, https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/pub-eng.pdf, accessed 7th February 2024.
4Health Canada, Guidance Document Management of Applications for Medical Device Licences, Effective date: 1st April 2020, https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/management-applications-medical-device-guidance-eng.pdf, accessed 7th February 2024.
5Health Canada, Part 1, Regulation 10 of Medical Devices Regulations SOR/98-282, Current to 31st December 2023, https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/index.html, accessed 2nd February 2024.