[title type=”special-h4-left”]Simplified procedures for Medical Device in Canada[/title]
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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.
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[title type=”special-h4-left”]Identify the application type[/title]
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- 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
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[title type=”special-h4-left”]Prepare the information for submission and submit to Health Canada[/title]
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- Prepared all required information for the specified class of medical device
- Include any required establishment licensing
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- 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.
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