UNIFICATION OF STANDARDS FOR THE PRODUCTION OF MEDICAL DEVICES – CASE OF THE FREE TRADE AGREEMENT BETWEEN THE EUROPEAN UNION AND THE REPUBLIC OF KOREA
DOI:
https://doi.org/10.61837/mbuir010123135zKeywords:
EU, Republic of Korea, EFTA, Medical, MDSAPAbstract
The entry into force of the free trade agreement between the European Union and the Republic of Korea on July 1, 2011 (EFTA) eliminated customs duties on 98.7% of products and removed non-tariff barriers to the export of key goods between them. The agreement in question is in many respects a pioneering solution both due to the broad subject of regulation and the degree of liberalization of trade, but also due to the fact that it is the first free trade agreement concluded by the European Union with an
Asian country and the first so-called "next generation". Thanks to the implementation of the provisions of the agreement, the parties managed not only to reverse the negative balance of bilateral trade, but also to change the material structure of imports and exports of goods, among which medical devices play an increasingly important role, together with pharmaceutical products generate an annual trade surplus of EUR 60 billion. This article analyzes the functioning of the medical device market in the context of EFTA EU-Republic of Korea pointing to the need for the parties to take steps to harmonize medical device certification standards with particular emphasis on the potential of MDSAP
References
https://apps.who.int - Medical Device Regulations: global overwiew and guiding principles, Accessed on:2022-07-22
Chatterji, A.K.; Fabrizio, K.R.; Mitchell, W.; Schul man, K.A. Physician-industry cooperation in the medical device industry. Health Aff. 2008, 27, 1532–1543.
http://eias.org-EU-South Korea FTA a ten year per spective, Accessed on: 2022-07-22
https://www.fda.gov/medical-devices/medical-de vice-single-audit-program-mdsap/mdsap-au dit-procedures-and-forms, Accessed on:2022-08-02.
https://iris.paho.org - Model regulatory program for medical devices: An international guide, Ac cessed on: 2022-07-22
Lamph, S., Regulation of Medical Devices outside of the European Union, J R Soc Med. 2012 Apr; 105(Suppl 1): p.12.
Lee, M.J., Yoon, Y., Ryu, G.H., Bok, H.S., Yoon, K.C., Park, S.W., Lee, K.S. Innovative distribution prior ities for the medical devices industry in the Fourth Industrial Revolution. Int. Neurourol. J. 2018, 22, p.83–90.
Medical Equipment Maintenance Market Size, Re port, Trends (2022 - 27) (mordorintelligence.com).
Medical Device Act, article 2 (Act No. 14330, De cember 2, 2016).
Medical Device Act Enforcement Regulation (Prime Minister Decree No. 1354, January 4, 2017).
Ministry Food and Drug Safety. Statistical Data for Medical Device Production and Import and Export in 2016; MFDS: Osong, Korea, 2017; pp. 2–19.
Moultrie, J.; Sutcliffe, L.; Maier, A. A maturity grid assessment tool for environmentally conscious design in the medical device industry. J. Clean. Prod. 2016, 122, 252–265.
https://policy.trade.ec.europa.eu, Accessed on: 2022-07-22
Sang-Soo Lee, Eugene Salole, Medical Device Re imbursement Coverage and Pricing Rules in Ko rea: Current Practice and Issues with Access to Innovation, [in:] Value Health 17, (2014), p. 476.
https://www.statista.com/statistics/909739/ south-korea-medical-device-export-val ue-by-country/, Accessed on: 2022-07-22
Sujin Kwak (28 March 2013) “MFDS Reforms and Takes a New Step Forward”. Ministry of Food and Drug Safety. Archived from the original on 16 Au gust 2022, Accessed on: 2022-08-16
The Enforcement Decree of Medical Device Act (Presidential Decree No. 27209, May 31, 2016).
Zaheer-Ud-Din Babar, Pharmaceutical Prices in the 21st Century, p.156, Pharmaceutical Pricing Policies in South Korea, I.-H.Lee and K.Bloor.
