Medical Devices

Canada’s Health Authority:

In Canada, manufacturers must receive a medical device licence for certain health products defined as a “device” under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a licence, all medical devices have been categorized based on the risks associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device licence.

Health Canada ‘Device’ definition:

A Device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in;

  • diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
  • restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
  • diagnosing pregnancy in human beings or animals,
  • caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
  • preventing conception in human beings or animals

GRP Medical Device Services:

Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in Canada who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device. GRP’s services continue to post-market vigilance of your product after registration in the Canadian market. 

More Resources:

  • Read More– To access more information on Medical Devices and our services in Canada .

Authorized local agent

Canada is one of the few countries with a well-developed regulatory system for drugs and medical devices where a local representative is not required to market a product within its borders. Foreign manufacturers can register and market their drugs and devices in Canada without a local representative, except in the case of devices containing wireless technology.

 

Global Regulatory Partners Services in Canada:

  • Communication with Health Canada
  • Product Registration
  • Assistance with Health Canada inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support Health Canada consultation meetings.
  • Recall or incident report assistance 

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest Health Canada regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Canada.

Regulatory Strategy

In Canada Devices are classified according to a risk-based system, as in most other markets a manufacturer’s regulatory requirements in Canada depend on its device’s classification. Manufacturers of most medical devices sold in Canada must obtain licenses through the Therapeutic Products Directorate’s Medical Devices Bureau and must be listed in the Medical Device Active License Listing (MDALL). Many lowest-risk devices (Class I devices) do not require such licensing, but the companies must register with the Health Products and Food Branch Inspectorate using Medical Device Establishment Licenses (MDEL).

Moderate- and high-risk devices must also meet ISO 13485 quality system requirements plus the Canadian specific additions to the ISO 13485 standard in order to be marketed in Canada.

Global Regulatory Partners Inc. (GRP) can assist you in evaluating the Canadian medical device regulatory framework as it applies to your device(s). We can provide you with accurate and actionable analysis through our Global Regulatory Overview Report service.

 

GRP Regulatory Strategy Services for Medical Device in Canada:

  • Health Canada Regulatory Background
  • Product Assessment based on Canadian Requirements
  • Device Classification based on Health Canada rules
  • Authorized Representation requirements for Canada
  • Medical Device Registration Requirements
  • Labeling Requirements
  • Costs and Timeframes
  • Regulatory Roadmap for Canada
  • Post-market Surveillance Requirements

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Canada include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Canada in order to successfully register and commercialize their products in the Canadian market and maximize the value of their assets.

Product registration

Medical devices are classified based on Health Canada’s risk-based classification system. Devices in Canada are classified as Class I, II, III and IV using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.  IVDs are also classified as Class I, II, III and IV using a set of 9 rules can be found in Schedule 1, Part 2 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.

If you are planning on selling medical devices or in vitro diagnostic devices (IVDs) in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada.

  1. Health Canada Medical Device Establishment License (MDEL)
  2. Health Canada Medical Device License (MDL)

Table 1: Health Canada Medical Device Classification

Device Class Description Type of Registration
Class I Lowest risk Culture Media
Class II Low risk Contact Lenses
Class III Moderate risk Implantable Coronary Stents
Class IV High risk Prosthetic Heart Valves

Table 2: Health Canada Medical Device Registration Pathways

Device Class Type of Registration
Class I Medical Device Establishment License (MDEL)
Class II, III, and IV Medical Device License

Health Canada Medical Device Establishment License (MDEL)

If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL). If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Health Canada Medical Device License (MDL)

The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.

Canada’s Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of securing an MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices.

When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality management system that also meets the specific requirements of the Canadian Medical Devices Regulations (CMDR).

GRP product registration services in Canada:

  • Confirming your device classification in Canada.
  • Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
  • Developing, implementing or modifying your ISO 13485:2003 quality management system to meet Canadian requirements.
  • Providing onsite employee training on ISO 13485:2003 and Canadian Medical Devices Regulations (CMDR).
  • Determining the proper annual license fee payable to Health Canada.
  • Providing onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Canada. As Regulatory authorities (Health Canada) expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

 It is highly recommended to have a pre-consultation meeting with health authorities such as Health Canada, during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with Health Canada before starting key milestone of your product development.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to Health Canada based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Clinical

Requirements for Clinical Trial conduct in Canada:

All investigational testing carried out in Canada must conform to:

  • The Declaration of Helsinki and the Medical Research Council’s “Code of Ethical Conduct for Research Involving Humans – May 1997. 
  • ISO14155-2011 “Clinical investigation of medical devices for human subjects-Good clinical practice, which is harmonized with ICH-GCP guidelines for medical device trials.

Pre-Market Review document for Class III and IV devices, may include the requirement of clinical data. Clinical data collected outside Canada is generally accepted by Health Canada. Manufacturer’s or device sponsors of Class II, III and IV medical devices who wish to conduct investigational tests for medical devices in Canada must submit an application for Investigational Testing Authorization.

Requirements for Approval of Clinical Trial Initiation:

An application for an investigational testing authorization of a Class II device must contain the following items presented in four distinct chapters titled: Introduction, Institutional Information, Protocol, and Labelling.

The application for an investigational testing authorization for a Class III or IV medical device must contain the following information in six distinct chapters: Introduction; Risk Analysis; Institutional Information, Protocol, Labelling, and Investigator Agreements

Table 1: Recommended content for an investigational testing application

(some sections are not applicable to Class II applications.)
Class II Application Content Content Description
1. Executive Summary
2. Background Information o 1 Device Description
o 2 Design Philosophy
o 3 Marketing History
3. Risk Assessment o 1 Risk Analysis and Evaluation
o 2 Previous Studies
o 3 Alternate Treatments
o 4 Precautions
4. Institutional Information o 1 Investigator(s)
o 2 Name of Institution(s)
o 3 Research Ethics Board Approval(s)
5. Protocol • the number of subjects, including a justification for the proposed number; • inclusion and exclusion criteria, including the participants’ ages, sex and diagnosis of primary and secondary (if applicable) conditions; and • the diagnostic methods chosen to confirm the disease or condition. • Methods of data quality control • The methods of assessing the investigational device • all case report forms to be used in the investigation. • The proposed methods of data analysis • the estimated time frame for the conduct of the study
6. Device Label • product monograph • Instructions for Use • Operator’s Manual • Training Manual • All advertising brochures intended to be used with the device.
7. Investigator Agreement(s) • conduct the testing in accordance with the protocol; • fully inform each enrolled patient; • not permit the device to be used outside the agreed protocol; • supervise the use of the device; and • report all incidents under Section 59 to the Minister within 72 hours.

Following the review of the application, the Minister may issue an authorization to conduct the proposed investigational testing.

Timeline :

As per the Medical Devices Division of Health Canada, the target review time for a Class II, III, and IV medical device ITA is a total of 30 calendar days.

Quality

QMS Requirements in Canada:

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third-party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.

  • The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.
  • Moderate- and high-risk devices must also meet ISO 13485 quality system requirements plus the Canadian specific additions to the ISO 13485 standard in order to be marketed in Canada.
  • Manufacturers of class II, III, and IV medical devices holding licenses or applying for new or amended license must complete the transition to ISO 13485:2016 by March 1st, 2019. 

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES IN CANADA

Manufacturers of Class II, III and IV devices must submit to Health Canada an ISO 13485:2003 quality systems certificate with medical device license applications. This must be issued by a by a registrar recognized by the Standards Council of Canada according to the CMDCAS. The registrar conducts a third-party audit for compliance with the standard and CMDR and issues the certificate with requirements specific to the CMDCAS program. Registration to the standard is an ongoing process, and related expenses are borne by the manufacturer. Manufacturers of Class I, special access, custom- made and investigational devices are exempt from this requirement.

Pharmaceuticals

Canada’s Health Authority:

In Canada, sponsors who want to register their drugs in Canada must apply for ” New Drug submission” and successfully complete the review process by scientists in the Health Products and Food Branch (HPFB). Once the sponsor  has completed the review the drug is issued a Notice of Compliance (NOC), and a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada.

Drug Definition in Canada:

According to the Food and Drugs Act, “a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

  • the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
  • restoring, correcting or modifying organic functions in human beings or animals; or
  • disinfection in premises in which food is manufactured, prepared or kept.”

Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations.

Market authorization in Canada:

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

More Resources:

  • Read More– To access more information on Pharmaceuticals and our services in Canada .

Authorized local agent

Canada is one of the few countries with a well-developed regulatory system for drugs and medical devices where a local representative is not required to market a product within its borders. Foreign manufacturers can register and market their drugs  in Canada without a local representative, except in the case of devices containing wireless technology.

GRP Pharmaceutical Services (Canada):

  • Communication with Health Canada
  • Product Registration
  • Assistance with Health Canada inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support Health Canada consultation meetings.
  • Recall or incident report assistance 

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest Health Canada regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Canada.

Regulatory Strategy

Global Regulatory Partners Inc. (GRP) approach to designing regulatory strategy employs our strong understanding of the Canadian market and  Health Canada regulatory systems to enable our clients to make confident, actionable decisions. We specialize in assisting pharmaceutical companies with their most difficult, complex endeavors and can help our clients to develop intelligent solutions in all areas.

Our regulatory team in Canada has the expertise in developing effective and tailored regulatory strategies that helped many foreign companies to register their products quickly and efficiently.

GRP regulatory strategy services (Canada):

  • Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
  • Proactively identify challenges or issues that may delay the approval of your pharmaceutical in Canada.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your pharmaceutical product registered in Canada.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally and in Canada, from their products’ development and registration till commercialization. GRP regulatory affairs services  in Canada include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

GRP Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Operations and Publishing
  • Product Registration
  • Products’ life cycle Management and Maintenance.
Regulatory Affairs | Global Regulatory Partners

Product registration

In Canada, drugs are authorized for sale once they have successfully gone through the drug review process. This process is how a drug application is reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada, and on occasion, outside experts, to assess the safety, efficacy and quality of a drug. Throughout the process, the safety and well-being of Canadians is the paramount concern.

Figure 1: Registration Pathway of New Drugs in Canada

New Drugs Registration Process in Canada:

Research for new drugs begins with scientists developing various chemical or biological substances. Once a substance has been isolated and purified, it is administered to tissue cultures or to a variety of small animals to see whether there are significant changes. These changes may be biochemical, physiological or behavioral in nature.

  • If promising results are obtained from these initial studies, a variety of animal and laboratory tests are conducted to study other effects of the substance [for example (e.g.) how it affects the immune system or reproductive system] and to determine what dosage of the substance should be given to achieve a particular effect.
  • If these preclinical tests indicate that a substance produces the desired result and is not toxic, the sponsor [that is (i.e.) the person or company who takes responsibility for the application] may apply to HPFB for authorization to conduct a clinical trial in Canada.
  • Sponsors who wish to conduct Clinical Trials in Canada must submit a Clinical Trial Application (CTA). Information contained in a clinical trial application includes the results from preclinical tests, production methods, dosage form and information regarding the investigators who will be conducting the study.
  • If clinical trial studies prove that the drug has potential therapeutic value that outweighs the risks associated with its use (e.g. adverse effects, toxicity), the sponsor may choose to file a New Drug Submission with HPFB.

Health Canada New Drug review process:

  1. When a sponsor decides that it would like to market a drug in Canada, it files a “New Drug Submission” (NDS) with HPFB. This contains information and data about the drug’s safety, effectiveness and quality. It includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.
  2. HPFB performs a thorough review of the submitted information, sometimes using external consultants and advisory committees.
  3. HPFB evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug.
  4. HPFB reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure).
  5. If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada and indicates the drug’s official approval in Canada.

In addition, Health Canada laboratories may test certain biological products before and after authorization to sell in Canada has been issued. This is done through its Lot Release Process, in order to monitor safety, efficacy and quality.

Priority Review Process: HPFB has a Priority Review Process in place which allows for a faster review to make available promising drug products for life-threatening or severely debilitating conditions, such as cancer, AIDS, or Parkinson’s Disease, for which there are few effective therapies already on the market.

Submission format: Health Canada has adopted the CTD format, and NDS submissions are required to be submitted as per CTD requirements.

Table 1: Application Review Timelines by Health Canada

Submission Timeline
New Active Substance: NDS 300 days
Clinical Supplements: SNDS 300 days
CMC supplements SNDS 60 days
Generic drugs: ANDS 180 days
CMC supplement SANDS 180days
Biologics: NDS 300days
Clinical Supplements SNDS 180 days
CTA and Amendments 30 days
CTA Bioequivalence 7 days

Table 2: APPLICATION CONTENT of New Drug Submissions

Module Content Binder / Label Color
1 Administrative and Product Information 1.0 Correspondence 1.1 Table of Contents (Modules 1 to 5) 1.2 Administrative Information 1.3 Product Information 1.4 Health Canada Summaries
1.5 Environmental Assessment Statement
1.6 Regional Clinical Information
1.7 Clinical Trial Application and Clinical Trial Application- Amendment Specific Requirements
1.A Appendix
Red
2 Common Technical Document (CTD) Summaries
2.1 CTD Table of Contents (Modules 2 to 5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
2.7 Clinical Summary
Yellow
3 Quality
3.1 Table of Contents of Module 3
3.2 Body of Data
3.3 Literature References
Blue
4 Nonclinical Study Reports
4.1 Table of Contents of Module 4
4.2 Study Reports
4.3 Literature References
Green
5 Clinical Study Reports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.4 Literature References
Black

*Notes:

  • Single copy of each document is usually required.
  • For combination products that require a joint review an additional copy of Modules 1, 2, and 3 is required.
  • To comply with Canadian GMP regulations companies first must register their domestic and global establishments.
  • In Canada, a drug establishment performing any of six licensable activities (fabricating, packaging/labeling, testing, importing, distributing and wholesaling) must apply for a Health Canada drug establishment license pursuant to Division 1A of the Food and Drug Regulations.