The Canadian medical device industry is evolving and dynamic with considerable growth potential. Entrepreneurs are showing growing interest to enter the Canadian medical device market. We have prepared this guide to help you easily register medical devices in Canada.
The Canadian medical device market: An overview
The Canadian medical device market is experiencing significant growth owing to increase in demand for advanced healthcare technologies. The market is diverse and mainly composed of small and medium-sized enterprises (SMEs). The market can be divided into the following segments:
- Diagnostic imaging
- Consumables
- Patient aids
- Orthopaedic and prosthetic
- Dental products
- Others
Factors, such as customer preferences, trends in the market, local special circumstances, and underlying macroeconomic parameters, are driving the demand for medical devices in Canada. Customer preference is being driven by growing demand for technologically advanced innovative medical devices offering improved patient outcomes and convenience. Additionally, patients are showing interest in medical devices that are portable, easy to use, and provide accurate and real-time monitoring. Moreover, personalized healthcare solutions, with demand for wearable devices and remote monitoring systems, are also driving the medical device market. Furthermore, increase in adoption of digital health technologies, such as telemedicine and electronic health records, is also a key factor. Additionally, focus on preventive healthcare, with a shift towards early detection, is driving the demand for innovative diagnostic medical devices for screening purposes.
With an increase in aging population, the demand for medical devices that cater to the needs of elderly patients is also increasing. Finally, Canada has a strong medical device research and development sector that is fostering innovation and technological advancements in the industry. Moreover, country’s well-established healthcare system, favourable government policies, and strong economy are all contributing to the growth of the Canadian medical device market.
Hence, Canada’s medical device market has a bright future offering a lucrative opportunity to entrepreneurs looking for a new business venture.
Registering medical devices in Canada
Canada has a stringent yet favourable medical device regulatory system.
Who regulates medical devices in Canada?
Health Canada, a department within the Government of Canada, regulates all medical devices entering the Canadian market. This apex body regulates and monitors all medical devices to ensure they are safe, perform as intended, and are of the highest quality.
How does Health Canada regulate medical devices?
All medical devices entering the Canadian market are expected to comply with the applicable medical device regulations. The regulatory authorities have laid the following requirements that medical devices must follow in addition to regulatory guidelines:
- Labelling requirements
- Safety and effectiveness requirements
- Distribution record requirements
- Complaint handling requirements
- Mandatory problem reporting
- Recall requirements
Furthermore, Health Canada has established a risk-based medical device classification system. This system has a major role in how medical devices are regulated in Canada. The classification of medical devices is as per the hazard/risk a particular device presents. Risk indicators used to categorise the medical devices are degree of invasiveness, duration of contact, body system affected, and local versus systemic effects. Based on these risk parameters, medical devices are broadly classified into four classes I, II, III, and IV. The classes in increasing order of risk level are as follows.
- Class I: Low risk medical devices are classified as Class I. Examples: Bandages, examination gloves, tongue depressors, thermometers, manual brushes, crutches, etc.
- Class II: Low to moderate risk medical devices are classified as Class II. Examples: Contact lenses, infusion pumps, hearing aid, powered toothbrush, etc.
- Class III: Moderate to high-risk devices are classified as Class III. Examples: Ventilators, orthopaedic implants, respirators, etc.
- Class IV: High-risk devices are classified as Class IV. Examples: Pacemakers, heart valves, artificial hearts, etc.
The class of medical device will determine the type of license required. Hence, for registering medical devices in Canada, the first and vital step is identifying the device class. The two major license types are as follows:
- Class I medical devices require the medical device establishment licence (MDEL).
- Class II to IV medical devices require the medical device licence (MDL).
What are the requirements for MDEL application?
Following are the mandatory requisites for MDEL application:
- Establishment details
- Manufacturer details
- Classification of devices to be imported or distributed
- Attestation signed by a senior official confirming the establishment possesses the required documented procedures
What are the requirements for MDL application?
Following are the mandatory requisites for MDL application:
- MDL application form
- Fee form
- ISO 13485:2016 quality management system (QMS) certificate under the medical device single audit program (MDSAP)
- Labelling document
- Premarket review document
- The private labellers are permitted to apply for the MDL only after the original medical device manufacturer is granted the MDL. The MDL application form for the private labellers is different from that for the original medical device manufacturers.
Responsibilities of manufacturers, importers, and distributors of medical devices in Canada
Different entities have different roles in the Canadian medical device regulatory environment. Medical device manufacturers, importers, and distributors all have their own roles and responsibilities. Hence, the medical device class and whether the entity is a manufacturer, importer, or distributor will determine whether MDEL or MDL is required.
- Manufacturer: A manufacturer sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person. Additionally, the manufacturer is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing, or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.
- Importers: An importer is a Canada-based company (other than the manufacturer) who is responsible for bringing the medical devices into Canada for sale.
- Distributor: A distributor is a company (other than the manufacturer or importer) either within or outside of Canada that sells devices in Canada for the purpose of resale or use.
The specific roles of the entities along with the medical device class will determine whether an MDEL or MDL is required. For instance, a distributor located outside Canada planning to sell medical devices in Canada, without their name on the label, will require an MDEL.
MDL specific requirements
- Medical device labelling requirements: Medical device labelling guidelines cover the label attached to the medical device and the Directions for Use. Both labels should include the name and identifier of the device, namely model number of the device. The “Directions for Use” should mention all the required instructions for the user to safely and effectively use the device. Additionally, the label should include a “control number’”, which is the serial, lot, or batch number.
- Quality management system certificate requirements: The quality management system (QMS) certificate accepted by Health Canada is the medical device single audit program (MDSAP) certificate. The MDSAP certification requires compliance with ISO 13485 requirements. Additionally, the QMS has to fulfil the regulatory requirements of the participating countries of MDSAP, namely United States of America (USA), Australia, Canada, Japan, and Brazil.
- Premarket review document: The premarket review document includes information demonstrating the safety and effectiveness of the medical device. For a Class II medical device, this document is mainly an attestation that evidence to support the compliance with applicable safety and effectiveness requirements is available. However, for a Class III and Class IV medical device, evidence to support compliance with the applicable safety and effectiveness requirements has to be submitted.
Pharmadocx Consultants will help you easily register medical devices in Canada
Planning to launch your medical devices in Canada? Need help registering your medical devices in Canada? Simply email at [email protected] or call/Whatsapp on 9996859227 for a seamless regulatory journey in Canada.
