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...
Africa
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules prescribing the collection of samples to be...
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...
