Ethiopia Medical Device Regulations

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EFDA – Ethiopian Food and Drug Administration

http://www.fmhaca.gov.et/

EFDA is the National Regulatory Body of Ethiopia which is under the Ministry of Health. The Authority is responsible to ensure the quality, safety and/or efficacy of medicines, food, cosmetics and medical devices. ... EFDA was established under the Ethiopian Food and …

Guideline for Registration of Medical devices 2014 – EFDA

http://www.efda.gov.et/publication/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 …

Regulation of Medical Device and its …

https://www.ethiobiomedical.com/2020/01/17/regulation-of-medical-device-and-its-registration-procedures-in-ethiopia/

Prior to their placement on the market in the territory, Ethiopia regulates medical devices just like any …

Medical Device Registration in Ethiopia - Thema Med

https://www.thema-med.com/en/medical-device-registration-ethiopia/

Medical Device Registration in Ethiopia redazione 2023-01-02T17:10:44+01:00. Regulatory Authority. Food, Medicine and Healthcare Administration and Control Authority of …

Medical Device Guidelines – EFDA

http://www.fmhaca.gov.et/doc-category/medical-device-guidelines/

Medicine and Medical Device Import, Export and Wholesale Control Directive 872/2022 By EFDA February 22, 2022 Medicine and Medical Device Import Export and Wholesale …

Ethiopia Medical device registration

https://operonstrategist.com/ethiopia-medical-device-registration/

ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes which is an ISO standard, it was published for …

Ethiopia Medical Device Registration - FMHCACA Approval

https://arazygroup.com/medical-device-registration-ethiopia/

LOCAL FEES (New Application): Medical Devices and IVDs (all classes) New product registration: USD 65 (including dossier pre-screening and evaluation) Minor …

EFDA Guidelines on Low-Risk Medical …

https://www.regdesk.co/efda-guidelines-on-low-risk-medical-devices/

May 7, 2021. Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published guidelines …

Change Control: Ethiopian Guidance for …

https://www.regdesk.co/change-control-for-medical-devices-in-ethiopia/

May 20, 2020. The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft …

Medical Device Registration in Ethiopia - omcmedical.com

https://omcmedical.com/medical-device-registration-in-ethiopia/

Determine the device classification. Appoint an Authorized Representative. The Local Representative should hold a license (issued by the Ministry of Trade) and a certificate of …

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