![EDA Guidance on Requirements for Unique Device Identification for Medical Devices: Basics](https://www.regdesk.co/wp-content/uploads/2021/12/cairo-1080x675.jpg)
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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![HSA Guidance on Medical Device Product Registration: Class C and D](https://www.regdesk.co/wp-content/uploads/2021/09/HSA-Guidance-on-Medical-Device-Product-Registration-Class-C-and-D-1080x675.png)
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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![HSA Guidance on Medical Device Registration: Basics](https://www.regdesk.co/wp-content/uploads/2021/09/singapore.jpg)
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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![EFDA Guidance on Medical Device Bundling](https://www.regdesk.co/wp-content/uploads/2021/05/Ethiopian-FDA-2-1080x675.png)
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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![Tanzanian Draft Regulation on Laboratory Analysis](https://www.regdesk.co/wp-content/uploads/2021/05/TMDA-Tanzania.jpg)
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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![EFDA Guidance on Post-Approval Change Notification](https://www.regdesk.co/wp-content/uploads/2021/05/Ethiopian-Flag-1-1080x675.jpg)
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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