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.