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...
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...
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 ...
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...
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...
Africa Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published guidelines dedicated to the regulatory procedures for placing low-risk medical devices on the market. The document constitutes the initial...
