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National regulatory regime


…The baseline country survey on medical devices was designed to determine the availability of policies, guidelines, standards and services for the assessment, management and regulation of health technology in Member States and Associate Members. It is WHO’s intention to determine the key areas for the development of health technology programmes in regions and countries which require support, as well as to share knowledge and information among the participating countries.

Countries will benefit from receiving comparable information from all other Member States and Associate Members. The information has been compiled into a comprehensive database, facilitating networking and decision making at all levels: national, regional and global.

As of 31 May, 114 submissions have been received out of a total of 196 Member States and Associate Members. There has been significant interest in the survey and we expect to receive the rest of the submissions during the coming weeks.

Please note that these are the preliminary results. As the survey is still ongoing, it is not recommended to cite or use the information as a reference…

The majority of countries responding to the survey do not have a health technology national policy. This refers to an official written document approved at national level to guide the management of health technology related activities such as medical equipment management, planning, assessment or regulation…

Sixty seven percent of respondents claimed to have an authority responsible for implementing and enforcing medical devices specific product regulations in the country (…read more)

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