This document provides high-level strategies for developing regulatory reliance programs for medical devices, along with specific considerations and steps related to actual program implementation. It is intended to be equally applicable to all medical devices. Unless otherwise specified, the reliance principles discussed in the document are intended to apply to any phase of the product lifecycle (e.g., technical documentation review, evaluation of quality management systems) and are meant to encompass a variety of different reliance mechanisms (e.g., harmonized decisions, unilateral or multilateral/mutual recognition, work-sharing). Some of the considerations may not be applicable to a particular reliance program due to factors such as the specifics of the regulatory system or the enabling legislative framework…
