Feb 8, 2021
Africa
The Tanzania Medicines & Medical Devices Authority (TMDA), the country’s regulating authority responsible for healthcare products, has published a draft regulation on good storage and distribution practices with regard to medicines and medical devices. Regulatory...
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Feb 8, 2021
Russia
An order of the Minister of Healthcare of the Russian Federation has been published. The order implements the administrative regulation the Roszdravnadzor shall follow when issuing establishment licenses to the entities engaged in manufacturing and maintenance of...
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Jan 24, 2021
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...
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Jan 24, 2021
EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document describing the rules on healthcare institution exemption for medical devices. It is important to mention...
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Jan 24, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to the key performance aspects in the context of the applicable standards for...
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