Medical Device Sector Regulatory Convergence is a concerted public-private effort to systematically pursue and maximize alignment of medical device sector-specific technical regulations, standards and conformity assessment criteria to internationally harmonized global standards.
According to the WHO, more them two million different types of medical devices circulate on the world market, categorized into more than 22,000 groups of generic devices. The regulation of medical devices contributes to the reduction of potential risks arising from their use and allows the population access to safe, effective and high quality medical devices, contributing to better public health outcomes.
On the control of these products , it is important to implement a globally aligned approach that, at the same time, contributes to the access of safe products and do not impede innovation or create unnecessary barriers to trade.
In this section you will find useful information on the following topics:
WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
International Medical Device Regulators Forum
Medical Device Single Audit Program (MDSAP)