Guidance for determining medical device application type: Disinfectants as medical devices

Since March 16, 2018, Health Canada has classified high-level disinfectant and sterilant solutions (including contact lens disinfectants) intended for use on medical devices as medical devices.

For more information, consult the following guidance document:

• Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices

Health Canada recommends that high-level disinfectant and sterilant solutions for general use be licensed or authorized as single medical devices on their own medical device licence or authorization. This is the most appropriate regulatory pathway for these types of disinfectant/sterilant solutions that are typically:

• not manufactured for a specific medical device system
• compatible for use with multiple medical devices

However, a high-level disinfectant or sterilant cartridge that is specific to only 1 medical device system should be added to the system licence or authorization through an amendment application, if it is from the same manufacturer.