Global regulations – Strategy, Documentation and Market Authorization

AKRA TEAM and its team of expert consultants support device manufacturers with global regulatory requirements including market access and support with specific local requirements. Medical devices and in-vitro diagnostics (IVD) requirements need to be considered for each regulatory jurisdiction where the device is envisaged to be sold. Global regulatory requirements are specific to each jurisdiction and may or may not be aligned with requirements of other major regulators. Market authorization may also depend on country-of-origin approval or mutual recognition (e.g. CE mark).

To ensure timely market access, it is important to ensure documentation is aligned with the expectations of the local regulator. Global medical device regulations may have specific expectations and guidelines that specify clinical, pre-clinical testing, manufacturing, and post-market requirements. Additionally, many global markets use IMDRF guidance as a basis which should be considered.

The requirements and/or guidelines change frequently in response to the state of the art (e.g., changes device technology, risk identified and standard of care). It is important to be mindful of existing requirements and new developments in the global markets.