Guideline for Application of Accessories and Spare parts_EFDA
Guideline for Application of Accessories and Spare parts_EFDA
Guideline for Medical Devices Bundling for Marketing authorization application
Guidance on criteria for bundling or grouping of medical devices
Guideline for Medical device Post-approval Change Notification EFDA
Guideline for Medical device Post-approval Change Notification_EFDA
Guideline for Marketing Authorization of Low risk Medical devices_EFDA
Guideline for Marketing Authorization of Low risk Medical devices_EFDA
EFDA_Guidelines for IVD Registration Requirements
EFDA_Guidelines for IVD Registration Requirements
EFDA_Guidelines for Non-IVD Registration Requirements
EFDA_Guidelines for Non-IVD Registration Requirements
Guidelines For Registration Of Medical Devices or Supplies
Medical supplies such as surgical dressings, surgical ligatures and sutures are standardized in many pharmacopeias and other monographs. The provisions of the medical supplies acts of many countries stipulate that this category of products comply with the quality specifications set for them. In view of this international trend, the Drug Administration and Control Authority of…
Guideline for Registration of Medical devices 2014
The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia was established to safeguard the health and safety of patients, users, and other persons by ensuring that manufacturers of medical devices follow specified procedures during the design, manufacture, and marketing as described in Proclamation No. 661/2009 for the regulation of medicines and…