Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study-Reference-Cited by-同舟云学术

Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study

Published:2023-05-21 Issue:5 Volume:57 Page:987-996
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Fufa Kebede,Marew Tesfa,Ashenef Ayenew^ORCID

Funder

Addis Ababa University

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s43441-023-00534-0.pdf

Reference28 articles.

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2. Sarah H, Maloney C, Phillips SD, et al. The evolving landscape of medical device regulation in east, central, and southern Africa. Glob Health Sci Pract. 2021;9:136–48.

3. GSMA-mHealth. Understanding medical device regulation for mHealth: a guide for mobile operators, GSMA connected living programme, Feb 2012. https://www.gsma.com/iot/wp-content/uploads/2012/03/gsmaunderstandingmedicaldeviceregulationformhealthreport1.pdf. Accessed 8 Feb 2021.

4. Peter L, Hajek L, Maresova P, et al. Medical devices: Regulation, risk classification, and open innovation. J Open Innov Technol Mark Complex. 2020;6:42. https://doi.org/10.3390/joitmc6020042.

5. WHO. Medical devices: Managing the mismatch: an outcome of the priority medical devices project. Geneva: World Health Organization; 2017. http://apps.who.int/iris/bitstream/10665/44407/1/9789241564045_eng.pdf. Accessed 07 June 2019.