Abstract
Many European medical device manufacturers are unfamiliar with the regulatory requirements, approvals, and timelines needed to market it in the Middle East. Due to the lack of publicly available information and regulatory frameworks, there is a huge difficulty for European manufacturers to market their products in the Middle East effectively. This paper’s main purpose is to summarize the regulatory requirements, outline a workflow as a vital component of successful strategic marketing, minimize the existing difficulty, and, thus, provide a model of maximum operational efficiency.
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References
Ammann, C.: Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. AAPS Pharm. Sci. Tech. 12(4), 1264–1275 (2011)
Devarajan, S., Mottaghi, L.: Middle East and North Africa Data Book [eBook]. World Bank Group, Washington, DC (2014). Available from: https://openknowledge.worldbank.org/handle/10986/20354. License: CC BY 3.0 IGO. Accessed 26 April 2017
European Commission: Guidelines relating to the application of the council directive 93/42/EEC on medical devices MEDDEV 2.4/1 Rev. 9 of June 2010. European Commission DG Health and Consumer Directorate B, Unit B2 “cosmetics and medical devices”. Off. J. Eur. Union OJ (L169), 1 (2010)
Lamph, S.: Regulation of medical devices outside the European Union. J. R. Soc. Med. 105(1_suppl), 12–21 (2012)
National Health Regulatory Authority: Medical Devices Registration/Importation Guideline. NHRA, Bahrain (2015)
Registration and Drug Control Department, Ministry of Health and Prevention, United Arab Emirates: Medical Device Registration Guideline. Ministry of Health, UAE (2011)
Saudi Food and Drug Authority (SFDA): MDS-G3 Guidance for Medical Device Authorized Representatives. SFDA, Kingdom of Saudi Arabia (2017)
Saudi Food and Drug Authority: MDS-G4 Guidance for Overseas Manufacturers. SFDA, Kingdom of Saudi Arabia (2017)
Wong, J., Kaiyu, R.T.: Handbook of Medical Device Regulatory Affairs in Asia, 1st edn. Pan Stanford, Hoboken (2013)
World Bank: The Little Data Book 2016 [eBook]. World Bank, Washington, DC (2016). Available from: https://openknowledge.worldbank.org/handle/10986/23968. License: CC BY 3.0 IGO. Accessed 26 April 2017
World Health Organization: Annex 2 stability testing of active pharmaceutical ingredients and finished pharmaceutical products, Technical Report Series, No. 953, WHO (2009)
Legislation
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Off. J. Eur. Union, OJ (L169), 1
Directive 2007/47/EC of the European parliament and of the council of 5 Sept 2007. Off. J. Eur. Union, OJ L247, 21
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Al-Khateeb, R. (2019). European Class III Medical Devices: Strategic Considerations for Marketing in the Middle East. In: Sakas, D., Nasiopoulos, D. (eds) Strategic Innovative Marketing. IC-SIM 2017. Springer Proceedings in Business and Economics. Springer, Cham. https://doi.org/10.1007/978-3-030-16099-9_16
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