According to the World Health Organization, about 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. The World Health Organization documents are internacional references that contribute to achieve this goal.

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
Good Regulatory Practices
Good Reliance Practices
Post Market Surveillance

REGULATORY COALITION PRINCIPAL MEMBERS