Canada Medical Device Regulations
Canada is one of the most regulated health authorities with updated regulation and governance allowing multiple and novel devices to be placed in the market. For new medical devices/ IVDs Health Canada emerges as one of the early implementers of medical device regulations with several strong and robust regulatory requirements
As per the Food and Drugs Act, Health Canada regulates the safety and efficacy of all medical devices marketed in Canada. Athreva with its medical device expertise can cater to regulatory requirements of manufacturers with a wide spectrum of services from device classifications to post marketing surveillance.
Regulatory assistance with formal classification of device with Health Canada
Support for obtaining Medical device establishment license (MDEL) for manufacturers
Diagnosis of existing technical documentation and compilation of Medical device licence technical file
Support with preparedness for MDSAP audit
Health Canada Medical Device Regulations
Health Canada regulates the medical devices, IVD and SAMD in-country in line showing similarity with the USFDA. Based on the risk assessment and intended use, a classification system is adopted by HC by segregating devices into four (04) different classes – Class I, II, III, IV.
Device classification and Market entry support
A market entry for product in Canada calls for different routes of device entry. As a first step, manufacturer needs to understand the regulations that exists for the device, which can be determined by knowing the classification and its applicable regulatory framework.
As per HC, medical devices are classified into 4 risk-based categories:
Class I, Class II, Class III and Class IV
How Athreva can assist medical device companies to classify the product in Canada
- Product classification support
- Gap analysis/ Diagnosis of existing technical file and generating a status report for analyzing regulatory requirements
- Compilation and submission of Medical device license
Proper classification of medical devices under HCs guidelines is important to understand the correct scope of regulatory window that arises from the HC concerning the route of device entry.
This can further reduce the loop of regulatory submissions, approval, and expenses.
Labeling, Artwork and Promotional Material Creation and Review
Athreva’s state-of-the-art in-house artwork studio and printing competency can assist medical device manufacturers with their labeling, artwork, printing and packaging requirements which are important and major cause of device recalls. It is imperative to ensure regulatory compliance of your label and promotional material according to the requirements as per HC. Inconsistent labels produced due to a lack of defined label creation process have far reaching implications – from concept finalization to final product sales. Dispensing with these issues needs a fresh approach and guiding hands of a domain expert.
Athreva can assist medical device companies in achieving end to end regulatory assistance and compliance with quality. We cater to the entire life cycle of the medical device value chain providing labeling and artwork solutions, right from comprehensive artwork check till regional language support.
Our labeling services includes following :
- Regulatory support for labelling design as per HC labelling regulations
- Gap analysis of the labels to meet regulatory requirements
- Advise on promotional material design as per regulatory requirements
Our Artwork Studio and printing services includes following :
- Creation of artworks as per HC requirement
- Promotional artwork creations for Print as well as Web platforms
- Proofreading of artworks
- Printing of artworks in Packaging material.