As with all regulated products, classification of a device is key to ensure a successful and efficient path to market. In all countries, medical device applications are highly specific, and the requirements of an application depend on the classification of the product in the intended market. Depending on the classification and the country, the device license may be associated with the manufacturing or importing facility or with the device itself.
In addition to the type, classification, and complexity of the device, the process, timeline and cost of applying for a medical device license depends on the quality systems in place at the involved facilities and the intended users of the device (personal or professional). In many countries, the manufacturing facility must be licensed by the regulatory authorities of the countries the product will be sold in.
Our team can classify your product, prepare and submit your medical device registration, and ensure your plan-to-market is complete by evaluating your facility, ensuring quality systems are complete and all is in place for a successful launch.
Find a list of our services on the left menu, or contact us for a facility/product evaluation – a unique service that evaluates your product/process/facility feasibility based on your plan-to-market, providing you with a customized overview of the regulatory processes you can expect for your business.