Kazakhstan
Kazakhstan has recently adopted new rules on clinical trials for medicines and medical devices, including clinical and laboratory examination of in vitro diagnostic medical devices. The new Order of the Minister of Healthcare of the Republic of Kazakhstan dated...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and healthcare products, has published detailed guidance dedicated to audits in the context of the Medical Device Single Audit Program (MDSAP). ...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices has published final guidance on labeling requirements for laparoscopic power morcellators. The present document constitutes a final version of the appropriate guidance...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance dedicated to the requirements related to the importation of medical devices for special purposes, such as demonstration or training. The present document constitutes an amended version of...
Asia
The Ministry of Health, Labour and Welfare of Japan (MHLW), the Japanese regulating authority responsible for medical device circulation, issued updated guidance dedicated to biocompatibility testing of medical devices. Biocompatibility Testing Standards According...
