Canada’s Health Canada
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.
- Health Canada Medical Device Establishment License (MDEL)
- 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
- Organize and support Health Canada consultation meetings.
- Recall or incident report assistance
Regulatory Services
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.
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.
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.
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. As Regulatory authorities 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.
Product registration
Overview:
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.
In general, it is highly recommended to have a pre-consultation meeting with health authorities such 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. GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.
GRP regulatory affairs team support services includes:
- writing ,
- preparation and submission of the meeting package to the health authority,
- prepare the questions to health authority based on the status of your product’s development and future plan,
- provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
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.
- 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.
- HPFB performs a thorough review of the submitted information, sometimes using external consultants and advisory committees.
- HPFB evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug.
- 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).
- 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.
Clinical
The process for gaining approval to conduct a clinical trial in Canada is efficient and straightforward, resulting in one of the world’s fastest trial start-up timelines. If applications are processed without encountering any difficulties, approval can be granted in 30 days.
A Drug sponsor seeking approval to conduct Phase I-III trials must submit a Clinical Trial Application (CTA) to Health Canada. (Some sponsors depend upon their clinical trial partners to complete the CTA.) The agency is required to respond within 30 days, either with an approval (in the form of a No Objection Letter (NOL)), a request for more information, or a denial. Sponsors are required to have the CTA signed by a scientific medical advisor who must be a physician or Ph.D. and residing in Canada. The information required on the CTA is very similar to that needed for an Investigational New Drug (IND) application in the U.S., and information prepared for one form can easily be “cut and pasted” into the other. Note that at this writing, CTAs are still submitted in hard copy form, however, Health Canada is piloting an e-submission process with the goal of moving to electronic-only submission. Sponsors must also get approval on their final protocols from the Ethics Committees at investigator sites or through a central IRB, although this effort can run in parallel with the CTA approval described above to save time. The documentation required from each site before it can be activated includes:
- A Clinical Trial Site Information Form. This can be sent to Health Canada as part of the CTA, although usually sponsors have not completed their investigator recruitment at the time that they file their CTAs
- A Research Ethics Board Attestation (REBA) or equivalent
- A Qualified Investigator Form
Requirements for conducting clinical trials:
- All investigational testing carried out in Canada must conform to the principles of the Declaration of Helsinki and the Medical Research Council’s “Code of Ethical Conduct for Research Involving Humans – May 1997.
- Clinical trials involving pharmaceuticals should be compliant with ICH: E6 good clinical practices.
Clinical Trial Application:
The modules are organized and numbered consistently in an internationally adopted format – the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by Health Canada and ensures consistency of documents in subsequent stages of the drug authorization process.
- Module 1 – contains administrative and clinical information about the proposed trial
- Module 2 – contains Quality (Chemistry and Manufacturing) information about the drug product(s) to be used in the proposed trial
- Module 3 – contains additional supporting Quality information
Quality
Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) primarily is responsible for health product compliance monitoring activities, such as industry inspection and product investigation. HPFBI develops and implements enforcement strategies in these areas. Establishment licensing and related laboratory functions support these compliance and enforcement activities. Applicable and useful Health Canada GMP regulations.
Pharmaceutical companies are responsible for complying with FDA and Health Canada regulations to maintain a high level of safety, efficacy and quality of their products. Compliance can be achieved by implementing a pharmaceutical quality system. Adherence to the internal PQS can ensure the identity, strength, quality and purity of drug products by requiring stringent control of every step in the lifecycle. It is important to know CGMPs only are minimum (baseline) standards. A well-designed PQS should exceed these standards.
GRP’s pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services:
- Full or “as needed” consulting for ISO and/or GMP quality assurance and regulatory affairs.
- Audits of your quality management system or a supplier’s quality system.
- Review of corrective actions and recommendations for resolution.
- Supporting quality metrics and analysis as part of the management review meetings.
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
Table 1: QMS Requirements in Canada for Drugs
| Title | Summary |
|---|---|
| Good Manufacturing Practices Guidelines–2009 Edition, Version 2 (GUI-0001) | Provides interpretive guidance for Part C, Division 2, of the Food and Drug Regulations. These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. |
| Annex 2 to the current edition of GMP Guidelines Schedule D Drugs (Biological Drugs) (GUI-0027) | Provides further guidance for Part C, Division 2, of the Food and Drug Regulations as they relate to biologic products. |
| Good Manufacturing Practices (GMP) Inspection Summary Reports | Define how inspection works, what inspectors look for and inspection ratings |
| Alternate Sample Retention Site Guidelines (GUI-0014) | These guidelines facilitate compliance to Section C.02.025 of the Food and Drug Regulations and enhance consistency in the application of the regulatory requirements by describing the requirements regarding Alternate Sample Retention (ASR) sites for finished drug products. |
| Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-069) | Shipping container requirements |
| Good Manufacturing Practices for Medical Gases (GUI-0031) | The guidance is regarding the fabrication, packaging, labelling, testing, distribution, and importation of medical gases. |
| Annex 2 to the current edition of the Good Manufacturing Practices Guidelines—Schedule D Drugs, Biological Drugs (GUI-0027) |
| Annex 13 to the current edition of the Good Manufacturing Practices Guidelines—Drugs Used in Clinical Trials (GUI-0036) |
| Annex 14 to the current edition of the Good Manufacturing Practices Guideline—Schedule D Drugs, Human Blood and Blood Components (GUI-0032) |
Cosmetics
Cosmetic Definition:
In Canada a cosmetic is defined as ” any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.“
GRP Cosmetic Services:
To overcome the complexities of cosmetic regulation in Canada Global Regulatory Partners, Inc.(GRP), offers a comprehensive range of services for Cosmetics and Personal Care Products to ensure products meet the latest cosmetic safety regulations. With regional offices in North America GRP is well-positioned to support your regulatory needs in Canada. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP helps manufacturers, distributors, and marketers of cosmetics in Canada.
More Resources:
- Read More- To access more information on Cosmetics and our services in Canada .
Authorized local agent
In Canada, Foreign manufacturers can register and market their cosmetics without a local representative. GRP Inc. can act as your regulatory consult for your cosmetic and personal care products. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP helps manufacturers, distributors, and marketers of cosmetics in Canada.
What is a Cosmetic in Canada?
According Section 2 to Food and Drugs Act – a cosmetic includes any substance, or mixture of substances, that is manufactured, sold, or represented for use in cleansing, improving, or altering the complexion, skin, hair, or teeth.
GRP Cosmetic Services (Canada):
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
Regulatory intelligence
Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in the Canadian market.
Regulatory Strategy
Developing the right regulatory strategy for your products for different markets is crucial for successful product development, registration, and commercialization.
Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets.
In developing the regulatory strategy, our team takes into consideration different factors such as;
- information on your products and similar products on the market,
- your product development status and milestones,
- your business goals and
- timelines,
- the regulatory requirements related to your product
- cost, and risk assessment.
Regulatory Affairs
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the Health Canada Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.
GRP Regulatory Affairs Services:
- Regulatory Intelligence (RI)
- Regulatory Strategy
- Regulatory Operations and Publishing
- Product Registration
- Products’ life cycle management and maintenance.
Cosmetic packaging and labeling review
The Consumer Packaging and Labeling Act:
The Consumer Packaging and Labeling Act and Regulations prescribe the mandatory information that must appear on the label of a pre-packaged cosmetic product which includes the:
- product’s identification in English and French,
- declaration of the product’s net quantity in metric units of measure in English and French, and
- identity and principal place of business of the dealer (see definition) in English or French.
the packaging should be constructed, or presented in such a way that the consumer will not be misled about the quality or quantity of the product contained inside. All information presented on a label must appear in such a manner that can be easily read.
Representation & claim:
The key consideration for the classification of a product is its proposed claim(s), defined in the Act as “representation for sale”. A claim can be a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites. Together, these claims are used to create a net impression of what the product is and does.
GRP Labeling Services:
GRP’s end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate Health Canada regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with Canadian requirements and the products can be used safely by the consumers. GRP can review your cosmetic packaging and labels to make sure it complies with Health Canada standards.
Product classification & Formulation Review
Cosmetic Ingredients:
Since November 2006, the Cosmetic Regulations require the disclosure of all ingredients on the label for all cosmetic products sold in Canada. A list of restricted and prohibited ingredients can be found on Health Canada website or can be accessed in our ‘More Resources’ section.
Cosmetic classification:
The classification of cosmetics is based on two main factors:
- composition of the product, and
- representations made about the product.
More Resources:
Nutraceuticals
‘Natural Health Product’ Regulations of Canada:
In Canada, nutraceuticals are known as Natural health products and are regulated under the Natural Health Products Regulations. However if the Natural health products (NHP) makes a therapeutic claim (s) they are considered drugs , and then will be regulated under the Food and Drug Act.
‘Natural Health Product’ Definition:
An NHP is defined as “A substance set out in Schedule 1 [NHPR] or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:
- The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
- restoring or correcting organic functions in humans; or
- modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However, a natural health product does not include a substance set out in Schedule 2 [NHPR], any of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or traditional medicine that is or includes a substance set out in Schedule 2 [1, NHPR].”
‘Natural Health Product’ Market Authorization:
All natural health products sold in Canada, must have a product license, and the manufacture, package, label and import these products must have site license. In order to get product and site license, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.
Authorized local agent
What are natural health products?
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
Natural health products, often called “complementary” or “alternative” medicines, include:
- vitamins and minerals
- herbal remedies
- homeopathic medicines
- traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines
- probiotics
- other products like amino acids and essential fatty acid
Global Regulatory Partners, Inc, (GRP) has a team of experts who helps NHPs and dietary supplements companies worldwide to register and commercialize their products in compliance with Health Canada regulatory requirements in terms of labeling , packaging, nutrient content claims and health claims. GRP has local offices in North America and strategic partners worldwide who can help you register and commercialize your NHPs and Food Supplements in the Canadian market.
Canada Licensing Requirements:
All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).
GRP ‘ Natural Health Product’ Services in Canada:
- Authorized local agent
- Regulatory intelligence
- Regulatory strategy
- Regulatory affairs
- Product Registration
- Verification of Nutrient Content Claims
- Verification of Health Claims
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 in Canada. GRP experts can collect the regulatory and other important requirements applicable from Health Canada to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in the Canadian market.
Regulatory Strategy
Developing the right regulatory strategy for your Nutraceuticals in Canada’s markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for different markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.
With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.
Regulatory Affairs
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Canada include regulatory intelligence, regulatory strategy, labelling , packaging, nutrient content claims and health claims.
Our Regulatory affairs teams can help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the Canadian Regulatory requirements in order to successfully register and commercialize their products in the Canadian market and maximize the value of their assets.
Verification of Nutrient Content Claims
Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Claims that relate to statements or other claims to the effect that a food’s energy (Caloric) value or a nutrient contained in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development. For example, “Energy [or naming the nutrient] is a factor in the maintenance of good health”.
In addition, the Health Canada regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.
Verification of Health Claims
Health claims or therapeutic claims refer to the treatment or mitigation of a disease or health-related condition, or about restoring, correcting or modifying body functions. For example, “[Naming the food or food constituent] lowers blood cholesterol”. are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. Global Regulatory Partners Inc. (GRP), team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements in Canada to make sure that they are supported by scientific data, are accurate and can be accepted by health authorities (Health Canada).
Types of Health Claims in Canada:
Modern Health Claims
Claims based on evidence from a range of sources, including (but not limited to) clinical studies, animal and in vitro studies, pharmacopoeias, textbooks, peer-reviewed published articles, and regulatory authority reports.
Traditional Health Claims
Claims based on the sum total of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture, used in the maintenance of health, as well as prevention, diagnosis, improvement, or treatment of physical and mental illness. For a claim to be categorized as “traditional use,” it should be founded upon the theories, experiences and beliefs embodying the respective ancient practice of medicine.