Regulatory classification 101: A guide to how your medical device will be classified

By Jon Speer

What I am about to share with you is a guide to medical device regulatory classification.

In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.

Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.

Regulatory Classification 101

Basically, every medical device is regulated in some way by regulatory agencies, such as FDAEuropean Commission, and Health Canada. These regulatory agencies have defined a bunch of rules and regulations (or “laws”) regarding medical devices.

The rules that apply to your medical device depend on how your product is classified by the regulatory agencies. Each regulatory agency has defined several different classifications for medical devices.



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