Ch 3 Managing Medical Devices within a Regulatory Framework

What is it about?

Abstract: Medical device classification is key in the determination of the proper regulatory path that will ensure that the device will meet safety and other standards in a specific country. Devices that do not undergo the complete product life cycle from innovation to postmarketing cannot expect their products to be released into the general population. Therefore, this chapter reviews important topics such as the determination of a predicate device or a "substantial equivalent' that will introduce various regulatory paths.

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Why is it important?

The various criteria in different regulatory paths help to categorize devices so that all quality conditions are taken under consideration and met in accordance to guiding country regulations. Without appropriate categorizations and accompanying documentation for submission, product applications can be rejected thus delaying product to market.