Global trade and health: an Indonesian perspective on the asean medical device directive policy

https://doi.org/10.22146/bkm.60819

Nurul Hidayati(1*), Dedy Almasdy(2), Abdi Setya Putra(3)

(1) Public Health Sciences, Faculty of Medicine, Andalas University
(2) Department of Clinical Pharmacy, Faculty of Pharmacy, Andalas University
(3) Public Health Sciences, Faculty of Medicine, Andalas University
(*) Corresponding Author

Abstract


Purpose: Health care equipment international trade could serve a new strategic revenue for Indonesia. Since its implementation in 2015, AFTA has been a very strategic issue in creating export opportunities for its member countries. One of the sectors that becomes a priority for ASEAN integration is in the field of medical devices which is regulated in the ASEAN Medical Device Directive (AMDD) policy. Indonesia itself has officially ratified AMDD policy since 2018, but Indonesia will have been facing the problem of quality, innovation and diversification of medical devices. This study examines the competitiveness opportunities for domestic medical devices in ASEAN Free Trade Area.

Method: This study used a qualitative method where information was obtained from in-depth interviews and document review. The informants came from policy makers, implementing officers, and stakeholders.

Results: Indonesia has harmonized 26 out of 31 standards mandated by AMDD. Conformity assessment bodies in Indonesia that have been certified by the National Accreditation Committee have received international recognition. Indonesia has many potential exporting innovative medical devices to ASEAN countries. Fulfillment of medical devices is carried out through compulsory licensing and parallel import mechanism.


Keywords


ASEAN medical device directives; medical device; quality; export

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References

  1. Saini KS, Kaushik A, Anil B, Rambabu S. Harmonized Medical Device Regulations: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia. Journal of Young Pharmacists. 2010; 2: 101–106.
  2. Medina LA, Okudan Kremer GE, Wysk RA. Supporting medical device development: a standard product design process model. Journal of Engineering Design. 2013; 83–119.
  3. Usman N. Implementation of Domestic Medical Device Industry Development Policy. Jakarta: University of Indonesia; 2017.
  4. Sari HR. Downstream Policy Analysis of Medical Device Research Results at Gadjah Mada University Yogyakarta in 2018. Jakarta: University of Indonesia; 2018.
  5. Anand K, Saini K, Chopra Y, Binod S. To recognize the use of international standards for making harmonized regulation of medical devices in Asia-pacific. J Young Pharm. 2010; 2: 321–325.
  6. Bettcher DW, Yach D, Guindon GE. Global trade and health: key linkages and future challenges. Bull World Health Organ. 2000; 78: 521–534.
  7. Velásquez G, Correa C, Seuba Hernández X. Intellectual property rights, research and development, human rights and access to medicines: an annotated and selected bibliography. 2012.
  8. Jung Y, Kwon S. The Effects of Intellectual Property Rights on Access to Medicines and Catastrophic Expenditure. Int J Health Serv. 2015; 45: 507–529.
  9. Sampath PG. Reconfiguring Global Health Innovation. London: 2010;
  10. Yusuf AA. Intellectual property protection in the countries of Africa. International Journal of Technology Management. 1995; 10: 269–292.
  11. Handoyoa RD, Wibowob W, Erlandoc A, Nurkumalasari RP. The Impact of Preferential Trade Agreement (PTA) on the Export of ASEAN + 4. International Journal of Innovation, Creativity and Chang. 2020; 13: 197–204.
  12. Akhmadi H. Assessment of the Impact of Asean Free Trade Area (AFTA) on Exports of Indonesian Agricultural Commodity. AGRARIS: Journal of Agribusiness and Rural Development Research. 2017; 3: 9–14.
  13. IS grace. ASEAN Free Trade Area (AFTA), Regional Autonomy and Trade Competitiveness of Indonesian Agricultural Commodities. Agro Economic research forum. 2016; 21.
  14. Vanhnalat B, Kyophilavong P, Phonvisay A, Sengsourivong B. Assessment of the Effect of Free Trade Agreements on Exports of Lao PDR. International Journal of Economics and Financial. 2015; 5: 365–376.
  15. Dhruva SS, Redberg RF. Medical device regulation: time to improve performance. PLoS medicine. 2012. p. e1001277.
  16. Kramer DB, Tan YT, Sato C, Kesselheim AS. Ensuring medical device effectiveness and safety: a cross-national comparison of approaches to regulation. Food Drug Law J. 2014; 69: 1–23, i.
  17. National Standardization Body Regulation No. 6 of 2018 concerning SNI Review Guidelines. 2018.
  18. Xiaofang Y, Chunren W, Deyu L. Reviews on Medical Devices Standardization System in China. World Congress on Medical Physics and Biomedical Engineering May 26-31, 2012, Beijing, China. Springer, Berlin, Heidelberg; 2013. pp. 1529–1532.
  19. Directorate General of Pharmaceuticals and Medical Devices. List of Medical Device Info, Medical Device Info Application. 2020.
  20. Jefferys DB. The regulation of medical devices and the role of the Medical Devices Agency. ritish journal of clinical pharmacology. 2001; 52: 229–235.
  21. Ramakrishna S. Quality Management Systems for Medical Device Manufacture. 2015.
  22. Groennvold W. New Regulations on Notified Bodies and Conformity Assessment of High-Risk Medical Devices in Europe: Impact on Clinical Investigation from an Industry Perspective. International Journal of Clinical Research & Trials. 2017; 2: 1–13.
  23. National Accreditation Committee. History and Functions of KAN, National Accreditation Committee. 2017.
  24. Jain A, Ganesh N, Venkatesh MP. Quality standards for medical devices. Int J Drug Regul Aff. 2018; 2: 19–24.
  25. Guerra-Bretaña RM, Flórez-Rendón AL. Impact of regulations on innovation in the field of medical devices. Res Biomed Eng. 2018; 34: 356–367.
  26. Siahaan S, Utami BS, Gitawati R, Handayani RS, Faatih M, Isfandari S. Situation Analysis of Intellectual Property Rights in the Health Sector in Indonesia. Health Systems Research Bulletin. 2018; 21: 97–103.
  27. World Trade Organization. Trade-Related Aspects of Intellectual Property Rights. 1994.
  28. Wong CK-K, Liew VK-S, Arip MA. The impact of ASEAN free trade area on intra-ASEAN manufacturing trade. International Journal of Business and Society. 2017; 18: 633–643.
  29. Hapsari IM, Mangunsong C. Determinants of AFTA members' trade flows and potential for trade diversion. ARTNeT Working Paper Series; 2006. Report No .: 21.
  30. Krucoff MW, Brindis RG, Hodgson PK, Mack MJ, Holmes DR Jr. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective. JACC Cardiovasc Interv. 2012; 5: 790–796.
  31. Roback K. Medical Device Innovation: The integrated processes of invention, diffusion and deployment. Institutionen för hälsa och samhälle. 2006.



DOI: https://doi.org/10.22146/bkm.60819

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