Simplified procedures for Medical Device in Canada
Classify the device
Atinza assist clients to classify medical devices into Class I to Class IV, based on the level of risk associated with their use. Higher risk devices receive higher classifications, and each level of classification requires different data for the application. Class I and devices used in clinical trials do not require licensing, but are still subject to establishment licensing and authorization requirements, respectively.
Identify the application type
The type of licence is important as it will also enable you to successfully market your product in Canada.
- The most common types include applications for New Licences, Amended Licences, and Private Label Licences.
- The most complex licenses are for Medical Device Kits and their components, Equipment (System) licences and their accessories
Prepare the information for submission and submit to Health Canada
Data requirements depend on the device class.
- Prepared all required information for the specified class of medical device
- Include any required establishment licensing
- Atinza will determine necessary contents to ensure successful entry of medical device to the Canadian market.
- Atiniza will communicate with Health Canada on client’s behalf during the development, submission, and post-market stages.