Dec 22, 2021
Africa
The Egyptian Drug Authority (EDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The scope of the guidance covers both...
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Sep 27, 2021
Africa
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the procedures and processes associated with medical device product registration. The initial article on the matter...
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Sep 9, 2021
Africa
The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a detailed guidance document describing the most important aspects associated with the registration of medical devices in order for them to be...
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May 18, 2021
Africa
The Ethiopian Food and Drug Authority (EFDA), the country’s regulating agency responsible for medical devices, has published a guidance document dedicated to medical device bundling in the context of marketing authorization application. Regulatory Background ...
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May 12, 2021
Africa
Tanzania Medicines and Medical Devices Authority (TMDA), the country’s agency responsible for healthcare products, has published a draft regulation prescribing the rules and procedures for laboratory analysis of medical and non-medical products. The new draft...
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May 11, 2021
Africa
Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority, has published guidance dedicated to post-approval change notification for medical devices. The document constitutes the initial version of guidelines developed by the authority. The...
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