Clients ask me what they need to do to market their medical device in different countries. Often times a company will have a sales lead in a new country or a business plan to take them there, but they are unsure of all the quality and regulatory steps to get them there.
The initial step to regulatory compliance is the device classification. Countries will have their own rules for classification that begins with an answer to the question, is your device a medical device? Depending where the device is in the life cycle, a straight forward answer to that question may be difficult to conclude. The vital information needed for classification include a device description and intended use.
It is best to collect the device’s regulatory information in one place, I call it the regulatory strategy document. Once you have what the device does, its characteristics, and who it helps, classification becomes more straight forward.
The next section of the regulatory strategy is the regulatory classification. Here, list each country you want to market the device in and its medical device classification rules and guidance sources. Make sure that you go back to each country’s website to find the most up to date rules and guidance. These lists are important, because they become your action list when classification has been determined. Next go through each country and perform your device classification. I usually will print out the guidance flow charts and highlight the pathway to classification real-time and add decision comments and action items if more questions need to be answered. Don’t do this in a vacuum include the product and development teams. Document the classification in a clear, bold format – I usually use a summary table.
The final section for each country becomes your actions. List out based on the classification the steps you need to take for premarket approval, quality system registration, post market requirements, specific device type requirements and you are ready to roll!