WHO: Majority of Nations Lack Device Regulatory Framework

More than half of the world’s countries do not have a comprehensive national regulatory regime for medical devices, although some of those do have device-specific regulations, according to a World Health Organization (WHO) survey. Of 114 ministries of health that responded to the survey on medical devices, 32 percent had a national policy on health technology and 57 percent did not. Ten percent said they had a policy, but it is not part of the national health program. However, 67 percent of respondents said they have an authority responsible for implementing and enforcing device-specific requirements in their country, according to a preliminary report on the survey.
International Medical Device Regulatory Monitor