MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the off-label use of medical devices. The scope of the guidance covers only the medical devices...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices has published detailed guidelines dedicated to sponsorship with regard to placing medical devices on the Australian market. Regulatory Background According...
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...
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