International Standardization refers to the work conducted within international Standards Developing Organizations (SDOs) to develop and maintain the globally harmonized documents that define the ever-evolving technical criteria underpinning medical device design, performance, safety, interoperability, cyber-security, and regulation. Per the guidance of the World Health Organization (WHO) and per the legally binding treaty obligation of the World Trade Organization (WTO), medical device regulators are required to use international standards as a basis for their national medical device technical regulations. International standards also define the rules for conformity assessment which is the various mechanisms by which industry can demonstrate compliance to standards.
In this section you will find useful information on the following topics:
Standardization and Conformity Assessment
Standards Development Organizations, Committees and Standards for Medical Technology
Use of International Standards by Medical Device Regulators