WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

The document presents the "WHO Global Model Regulatory Framework for Medical Devices," which includes in vitro diagnostic (IVD) medical devices. Medical devices play a crucial role in achieving high health standards, enabling everything from basic procedures like bandaging to complex surgeries and diagnoses. The document emphasizes the importance of medical devices in various settings, from home use to advanced medical facilities.

The WHO Global Model Regulatory Framework aims to guide countries in developing and implementing regulatory controls for medical devices. Recognizing that many nations may lack the resources or expertise to transition from an unregulated market to a comprehensive regulatory system, the framework recommends a stepwise approach. This approach starts with basic regulatory controls, such as publishing laws and resourcing regulatory authorities, and progresses to expanded controls, like inspection of registered establishments.

The framework provides definitions for "medical devices" and "IVDs." A medical device encompasses a broad range of instruments, appliances, software, and other related articles intended for specific medical purposes, such as diagnosis, treatment, or prevention of diseases. IVDs are devices used for in vitro examination of specimens from the human body, primarily for diagnostic or monitoring purposes.

The document also outlines the principles of good regulatory practice and the necessary conditions for effective medical device regulation. It discusses the roles and responsibilities of a country's regulatory authority and introduces techniques of reliance and recognition for regulatory practices.

Furthermore, the framework touches upon additional topics relevant to medical device regulation, such as disposal, donations, reprocessing of single-use devices, refurbishing electromedical devices, and addressing substandard and falsified products.