Recent ISO Standards Highlight Global Submission Complexities

Submitting a medical device for regulatory approval is typically a long and laborious process—and rightfully so. A device’s classification, the primary mode of action, relevant regulatory standards, and testing requirements determine the submission requirements specific to each product. Evolving regulatory requirements and standards mean manufacturers can anticipate regulatory delays, timeline shifts and fixed project milestones. When preparing to submit a medical device to multiple regulatory bodies around the world, the number of factors to consider can be downright daunting.

Despite their challenges, global submissions may be ideal for manufacturers on several fronts. Access to international markets means bringing life-changing medical devices to a significant number of patients internationally, in addition to a financial windfall. However, submitting to multiple regulatory bodies means ensuring a medical device adheres to each regulatory body’s requirements and interpretation of standards from the International Organization of Standards (ISO).

The language used in regulatory standards can be vague and subject