World Health Organization (WHO) has asked member countries to ensure implementation of essential principles of safety and performance regulations in purchase of medical devices to use in the hospitals. According to WHO report on Global Model Regulatory Framework for Medical Devices, growing interest in medical devices in the global health community and the lack of regulatory systems for medical devices in many countries, WHO decided to develop this document.
It said many WHO member states have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks to ensure the quality and safety of medical devices available in their countries. It said that many countries have neither the financial resources nor the technical expertise to transition successfully from an unregulated market to a comprehensive medical devices law in a single programme. Instead, the WHO model recommends a progressive, or stepwise, approach to regulating the quality, safety and performance of medical devices as it provides guidance for a staged development of the regulatory system. —APP