Medical devices have an indispensable role in the healthcare industry. They need to be strictly monitored and regulated for safety, efficacy, and quality to deliver high quality healthcare to patients. Their regulation plays a vital role in safeguarding the healthcare system and ensuring patient safety. Health Canada is the primary authority responsible for overseeing the safety, efficacy, and quality of medical devices in Canada. The regulatory authorities have classified medical devices into four classes, I, II, III, and IV, for ease of registration and licensing. Health Canada grants medical device licence (MDL) to allow manufacturers to sell or import Class II, III, and IV devices. We have prepared this guide to help you easily secure the Health Canada medical device licence (MDL).
The Canadian medical device classification system
The Canadian medical device classification system is based on the level of risk associated with the medical device’s intended use. The medical devices have been categorised into four classes, I, II, III, and IV. The classes are arranged in increasing order of risk level.
- Class I: Low risk medical devices are classified as Class I. Examples: Bandages, examination gloves, tongue depressors, thermometers, etc.
- Class II: Low to moderate risk medical devices are classified as Class II. Examples: Contact lenses, infusion pumps, etc.
- Class III: Moderate to high-risk devices are classified as Class III. Examples: Ventilators, orthopaedic implants, etc.
- Class IV: High-risk devices are classified as Class IV. Examples: Pacemakers, heart valves, etc.
Class I medical devices are subjected to least rigorous regulatory pathways as they have the lowest associated risk level. Being associated with higher risk levels, class II, III, and IV medical devices undergo a rigorous review to ensure their safety and efficacy.
Health Canada Medical Device Licence (MDL)
All medical devices entering the Canadian market are expected to comply with the applicable medical device regulations. The Medical Device Licence (MDL) is issued to those devices that meet the necessary Canadian safety, quality, and efficacy benchmark.
What is Medical Device Licence (MDL)?
Medical device licence (MDL) is issued by Health Canada to authorize manufacturers to legally sell or import Class II, III, or IV medical devices in Canada. To secure the Health Canada MDL, you need to determine your device’s classification depending on its associated risk level. This is vital for choosing the correct licensing pathway for your medical device, as the license type required will depend on your device’s class. Furthermore, you need to obtain the necessary certification, submit a duly filed application, and adhere to the medical device single audit program (MDSAP) requirements.
Requirements for obtaining Health Canada medical device licence (MDL)
Medical device manufacturers are required to mandatorily comply with the Canadian medical device regulations (MDR) to secure the medical device licence (MDL). The regulations are in place to ensure the highest quality, safe, and effective medical devices are available in the Canadian healthcare system. Thus, a licensed product guarantees a healthcare provider that they are using the best devices for their patient. Moreover, having an MDL, improves the credibility of the medical device manufacturer. It demonstrates compliance with strict regulatory guidelines and quality standards, thereby commitment to patient safety and improved outcome. Thus, medical device manufacturers are required to fulfil certain requirements to secure the Canada MDL. We have highlighted some of the requirements.
- Securing the ISO 13485:2016 certificate under the Medical Device Single Audit Program (MDSAP) is a pre-requisite to apply for an MDL. This demonstrates compliance with the quality management system (QMS) requirements of Health Canada. Compliance with MDSAP ISO 13485:2016 certification requirements is mandatory for securing the Health Canada medical device licence (MDL).
- 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.
- The MDL application form has to be submitted to Health Canada.
Who needs an MDL?
Entities planning to manufacture Class II, III, and IV medical devices for sale or import in Canada are required to secure an MDL.
Health Canada medical device licence (MDL) application process: Step-by-step guide
- Check medical device class: The first and a vital step in the MDL application process is to check which class your medical device belongs to. This will determine the license type required and the next step in the application process.
- Compliance with MDSAP: Compliance with the medical device single audit program (MDSAP) requirements is mandatory. Thus, securing the ISO 13485 quality management system (QMS) certificate per MDSAP requirements is necessary for obtaining the MDL.
- Application submission: Fill in the MDL application form and submit it to the Health Canada. Pay the required application fees.
- Submit the necessary documents: Prepare the necessary documentation and submit it along with labelling documents and the MDSAP certificate.
- Health Canada review and license approval: Health Canada regulatory officials will review your application and verify all the documents. If all the criteria are satisfied, they will approve the application and grant the MDL.
Why should you choose Pharmadocx Consultants?
- Expertise in Canadian Medical Device Regulations: Our team is well-versed with the nuances of medical device regulations (MDR) of Health Canada. We will ensure that your application aligns perfectly with the regulatory requirements, increasing the chances of swift approval.
- Document preparation and review: With our in-depth knowledge of the required documentation, we provide thorough assistance with document preparation.
- Post-License Support: Our relationship does not end with the license approval. We offer post-license support, assisting with any regulatory changes that might affect your business.
- Cost-Effective Solutions: We offer competitive pricing ensuring you get the best services at a reasonable cost.
- Client-Centric Approach: Our clients are our top priority. We tailor our services to meet your specific needs, ensuring a personalized experience.
- Regular Updates: We provide regular updates on the status of your application, ensuring you are always on the loop.
- End-to-End Assistance: From license application to license approval, we are with you in every step of the journey.
In the ever-evolving landscape of medical device regulations, having a trusted partner, like Pharmadocx Consultants, can make all the difference.
How can Pharmadocx Consultants help you get the Health Canada medical device licence (MDL)?
We provide comprehensive service to our clients for easily securing the Health Canada medical device licence (MDL). Our all-in-one service provides everything you need to have a smooth regulatory journey in Canada.
- Assistance in correctly classifying the medical device, a crucial step that will determine the regulatory pathway.
- Preparation, compilation, and review of the technical dossier.
- Thorough gap analysis of the documents.
- Ensuring your medical device meets all Health Canada regulatory requirements.
- Preparation of medical device licence (MDL) application.
- Medical device labelling services as per Health Canada labelling requirements for medical devices.
- Thorough review of the labelling documents.
- Medical device single audit program (MDSAP) support service.
- Acting as a liaison between clients and Health Canada officials, answering all queries.
- Providing ongoing support for post market surveillance and adverse event reporting.
- Providing ongoing post license application support for continuous compliance with latest guidelines.
Backed by years of experience, our MDL application process is streamlined and time-efficient. We offer cost-effective comprehensive client-centric services to medical device manufacturers. Drop an email at [email protected] or call/Whatsapp on 9996859227 to secure your Health Canada medical device licence (MDL) in a seamless manner.
