CDMR Canada Medical Device Registration
Canada, with its population of over 38 million, relies heavily on imports to meet approximately 70% of its domestic demand for medical devices. The country's medical device sector is witnessing a surge in demand, fueled by an increase in chronic diseases and an aging population. This presents a significant opportunity for global medical device manufacturers.
Complying with Canadian Regulations
Regulatory Authority
Pure Global can assist with Canada's medical device registration, ensuring CMDR approval to sell in the Canadian market.
Classification
Canada categorizes medical devices into four classes based on the risk they pose. This classification influences the regulatory requirements for approval:
- Class I devices, considered low risk, require a Medical Device Establishment License (MDEL) for manufacturers or importers.
- Class II, III, and IV devices, representing higher risk levels, must obtain a Canadian Medical Device License (MDL) and undergo certification through the Medical Device Single Audit Program (MDSAP).
Key Requirements
The path to market involves:
- Classifying your product correctly.
- Obtaining an MDEL for Class I devices or an MDL for Classes II to IV devices.
- Undergoing MDSAP certification for Class II to IV devices.
Foreign manufacturers benefit from not having to appoint a local license holder, streamlining the process for market entry.
Tailored Support for Market Entry
We offer comprehensive support to streamline your market access in Canada:
Classifying and grouping your products to define the regulatory pathway.
Assisting with the compilation of the technical dossier for MDL or MDEL applications.
Guiding you through the MDL or MDEL application process to ensure compliance with Health Canada's requirements.
Frequently
Asked Questions
What are the key regulatory authorities for medical device registration in Canada?
The primary regulatory authority for medical device registration in Canada is Health Canada. Pure Global can assist with navigating the registration process to ensure compliance with the Canada Medical Device Regulations (CMDR) and secure approval to sell medical devices in the Canadian market.
How are medical devices classified in Canada, and what are the regulatory requirements for each class?
Medical devices in Canada are classified into four classes based on their risk levels, in accordance with Health Canada regulations medical devices: • Class I (low risk): Requires a Medical Device Establishment License (MDEL) for manufacturers or importers. • Class II, III, and IV (higher risk): Require a Canadian Medical Device License (MDL) and certification through the Medical Device Single Audit Program (MDSAP)
. What are the steps involved in bringing a medical device to the Canadian market?
To bring a medical device to the Canadian market, you need to: 1. Classify your product correctly according to MDR Canada. 2. Obtain an MDEL for Class I devices. 3. Obtain an MDL for Class II, III, and IV devices. 4. Undergo MDSAP certification for Class II, III, and IV devices
Do foreign manufacturers need to appoint a local license holder to sell medical devices in Canada?
No, foreign manufacturers do not need to appoint a local license holder to sell medical devices in Canada. This provision helps streamline the health canada medical device approval process for foreign medical device manufacturers.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.