WHO/Europe takes steps for better regulation of medical devices in the Region

WHO/Jerome Flayosc

To start applying new WHO global guiding principles for the regulation of medical devices in the WHO European Region, WHO/Europe organized a 3-day workshop in Yerevan, Armenia, on 3–5 October 2017.

The guiding principles for regulating medical devices, and a progressive, stepwise approach to regulating their quality, safety and performance, are set out in the WHO global model regulatory framework for medical devices. WHO launched the model in May 2017.

The 3-day seminar in Yerevan focused on the implementation of the model in 5 countries of the Region: Armenia, Georgia, Kazakhstan, Kyrgyzstan and Ukraine. It brought together 23 experts working on medical device regulation in these countries. At the seminar, each of the participating countries developed a roadmap for regulation and outlined specific activities for the coming years.

In his opening statement, Sergey Khachatryan, Deputy Minister of Health for Armenia, commented that learning from other countries about challenges in regulating medical devices and ways of overcoming them would be useful.

Hakob Topchyan, Director of the Scientific Centre of Drug and Medical Technology Expertise of Armenia, stressed the importance of “a strong regulatory function in countries and collaboration among countries within the new Eurasian Economic Union to fight the importation of counterfeit medical devices”.

Medical devices are used in nearly all medical procedures, from common ones such as measuring blood pressure and conducting minor surgery to implant pacemakers, to complex procedures such as robotic surgery. They are used in diverse settings ranging from homes to remote clinics to advanced medical facilities. Today, there are an estimated 2 million different kinds of medical devices on the world market.

The regulation of medical devices is essential to ensure their quality and safety. The 53 countries in the Region are in various stages of regulation – some have yet to develop and implement regulatory controls for medical devices, while others are in the process of improving their regulatory frameworks.