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MEDICAL DEVICE CONSULTING

Are you a medical device manufacturer, importer, distributor, or any entity involved in the healthcare industry? If so, compliance with Health Canada's regulations is paramount, and securing a Medical Device Establishment License (MDEL) and Medical Device License (MDL) is often a mandatory step in your journey. At The MedNerds, we specialise in providing expert assistance in obtaining these crucial licenses, ensuring your seamless entry into the Canadian healthcare market.

Medical devices in Canada cover health and medical instruments such as pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.

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Medical devices in Canada are classified into one of four classes. While Class I does not require any medical device license, Classes 2, 3, and 4 do. All classes of medical devices in Canada must be manufactured under Canadian medical device regulations.  We can guide you through the MDEL listing, the MDEL licensing process, medical device regulations, and what an MDL costs.

Who Needs a Health Canada Medical Device Establishment License and Medical Device License?

  1. Medical Device Manufacturers: Manufacturers of medical devices, regardless of their location, must obtain an MDEL to establish their presence in Canada.

  2. Importers and Distributors: Companies importing and distributing medical devices within Canada need an MDEL to ensure the safety and quality of the products they bring to market.

  3. Healthcare Facilities: Certain healthcare facilities that reprocess single-use medical devices require an MDEL to comply with Health Canada's regulations.

Classes of Medical Devices

Canada classifies medical devices into four main classes based on their risk level and potential impact on patient safety. Understanding these classes and their associated requirements is essential for manufacturers, importers, and distributors seeking to navigate Health Canada's regulatory landscape.

Class I Medical Devices

  • Examples: Bandages, dental instruments.

  • Requirements: MDL application, CMDR compliance, no MDEL required.

Class II Medical Devices

  • Examples: Infusion pumps, hearing aids.

  • Requirements: MDEL, MDL application, CMDR compliance.

Class III Medical Devices

  • Examples: Pacemakers, ventilators.

  • Requirements: MDEL, rigorous MDL application, CMDR compliance, clinical data.

Class IV Medical Devices

  • Examples: Implantable devices, high-risk diagnostic imaging.

  • Requirements: MDEL, stringent MDL application, CMDR compliance, extensive clinical data.

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How We Can Help

Navigating Health Canada's regulatory requirements for medical devices can be intricate and time-consuming. Here's how The MedNerds can assist you:

  1. MDEL Application Support: We provide comprehensive guidance and support in preparing and submitting your Medical Device Establishment License application. Our experts ensure that your application is accurate, complete, and compliant with Health Canada's stringent requirements.

  2. MDL Application Assistance: Obtaining a Medical Device License is critical for marketing medical devices in Canada. Our team can help you prepare and submit your MDL application, ensuring that your product meets all safety and efficacy standards.

  3. Regulatory Expertise: Our seasoned professionals have an in-depth understanding of Health Canada's regulatory landscape. We keep abreast of the latest updates and changes, ensuring that your applications align with the most current requirements.

  4. Documentation and Compliance: We assist in compiling the necessary documentation, including quality management system documentation, clinical data, and labeling, to demonstrate compliance with Health Canada's regulations.

  5. Timely Support: We understand the importance of timely approvals in the healthcare industry. Our team is committed to delivering results efficiently, helping you bring your medical devices to market sooner.

Devices We Have Licensed

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PPE

Surgical Equipment

Invitro Diagnostics

Monitoring Devices

Personal Care

Radiology

Are you planning to obtain MDEL or MDL?

The first crucial step towards achieving this goal is ensuring that your business has Standard Operating Procedures (SOPs) in place, compliant with Health Canada's guidelines for Incident Reporting, Distribution Records, Complaint Handling, and Product Recalls. That's where we come in.

Our team of seasoned regulatory experts has a deep understanding of Health Canada's stringent medical device regulations. We have meticulously crafted SOPs that not only meet but exceed the regulatory requirements set forth by Health Canada. These SOPs are designed to make your business audit-ready, ensuring you are well-prepared to demonstrate compliance during the licensing process.

We offer a comprehensive package of SOPs that cover Incident Reporting, Distribution Records, Complaint Handling, and Product Recalls, tailored to your specific business needs. These SOPs have been vetted and refined to ensure they align perfectly with Health Canada's medical device regulations.

Take the first step today by ensuring your business has the right SOPs in place, and let our experienced team guide you through the application process.

Documented Procedures | MDEL Health Canada

At The MedNerds, we are committed to providing exceptional services to support your business. Our expertise in regulatory compliance and quality assurance will give you the confidence to navigate the complex landscape of the healthcare industry. Get in touch with us today to learn more about how we can help you.

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