As Medical device application in disease prevention, diagnosis or treatment is evolving to a greater extent; there is a need for regulation to monitor its quality, safety and efficacy. The present article attempts to study the medical device regulation available in eleven South-East Asian World Health Organization (WHO) member countries. The information searched from the available sources reveals that medical device regulation exists in seven countries. Most of the countries follow the International Organization for Standardization (ISO) 13485 for their quality standards in medical devices. Most countries also specified the time frame and authority to which adverse event is to be reported. Countries like India and Thailand have separate Adverse Event reporting forms for the medical device. The present study reveals that there is no separate web-based database for adverse event reporting of medical devices. Therefore, WHO South-East Asian Regulators Network (SEARN) under South East Regulatory Office (SERO) office may provide handholding support to these regions in developing a common software or tool for the management and analysis of signals arising from the adverse events.
Cite this article:
Vivekanandan Kalaiselvan, G. Aishwarya, Ashish Sharma. Medical device’s regulation in South-East Asian countries: Current status and gap areas. Asian Journal of Pharmaceutical Research. 2021; 11(3):173-9. doi: 10.52711/2231-5691.2021.00032
Vivekanandan Kalaiselvan, G. Aishwarya, Ashish Sharma. Medical device’s regulation in South-East Asian countries: Current status and gap areas. Asian Journal of Pharmaceutical Research. 2021; 11(3):173-9. doi: 10.52711/2231-5691.2021.00032 Available on: https://asianjpr.com/AbstractView.aspx?PID=2021-11-3-6
1. WHO | Medical Device – Full Definition. WHO. 2018. http://www.who.int/medical_devices/full_deffinition/en/. Accessed March 11, 2021.
2. Bhat BB, Prabhu PP, Lobo MJ, Anusha, Prathvi, Venkatesh Kamath B. Medical device industry in india: Past to present. Res J Pharm Technol. 2019;12(12):5959-5962. doi:10.5958/0974-360X.2019.01034.5
3. Medical Devices Market Global Opportunities and Strategies. https://www.thebusinessresearchcompany.com/report/medical-devices-market. Accessed March 11, 2021.
4. Com I. WHO Global Model Regulatory Framework for Medical Devices Including In vitro Diagnostic Medical Devices WHO Medical Device Technical Series.; 2017. http://apps.who.int/bookorders. Accessed March 11, 2021.
5. Chavhan AB, Bhoi DM. Pharmacovigillance: Drug Safety Monitoring. Asian J Pharm Technol. 2019;9(1):49. doi:10.5958/2231-5713.2019.00009.6
6. Overview of Device Regulation | FDA. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation. Accessed March 11, 2021.
7. Janarthanan S, RajuKamaraj. Medical Device regulation in U.S. Res J Pharm Tech. 2020;13(9). doi:10.5958/0974-360X.2020.00786.6
8. Santhosh S, Kamaraj R. 510(K) premarket notification. Res J Pharm Technol. 2018;11(12):5675-5780. doi:10.5958/0974-360X.2018.01028.4
9. Medical devices | European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices. Accessed March 11, 2021.
10. South-East Asia Regulatory Network (SEARN). https://www.who.int/southeastasia/activities/south-east-asia-regulatory-network-(searn). Accessed March 11, 2021.
11. WHO | South-East Asian Region. https://www.who.int/choice/demography/seasian_region/en/. Accessed March 11, 2021.
12. About us. https://www.searn-isp.org/SEARN/en/About/. Accessed March 11, 2021.
13. Directorate General of Drug Administration. Registration Guidelines for Medical Devices Bangladesh.; 2015. https://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/guidance-documents/127-medical-device-registration-guideline-2015/file.
14. Authority D regulatory. Medical Device Control Strategy 2018-2023.; 2018. http://www.mdb.gov.my/mdb/index.php.
15. Ministry of food and drug safety. Your Vision, Our Future Korean Medical Device.; 2019. https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72620&data_tp=A&file_seq=1.
16. Regulation on Management of Safety Information Including Medical Device Side Effects Etc.; 2016. https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=70111&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=2.
17. ministry of health and family welfare. Medical Device Rule Gazette Notification.; 2017. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNg==.
18. Indian pharmacopoeia commission. Guidance Document Materiovigilance Programme of India (MvPI) Version 1.2.; 2020. http://www.ipc.gov.in/images/Guideline_-_11-03-2020.pdf.
19. WHO. National Regulatory Authority.; 2015. https://www.who.int/medical_devices/countries/regulations/idn.pdf?ua=1.
20. Indonesia Medical Device Registration | Asia Actual LLC. https://asiaactual.com/indonesia/medical-device-registration/. Accessed October 13, 2020.
21. Medical Device Bill. http://origin.searo.who.int/maldives/documents/medical_devices_bill.pdf.
22. Authority NR. Maldives.; 2015. https://www.who.int/medical_devices/countries/regulations/mdv.pdf?ua=1.
23. Definition of Medical Device - Food and Drug Administration, Myanmar. https://www.fda.gov.mm/?p=920. Accessed September 16, 2020.
24. department of drug adminstration. Directive on Health Technology Product and Equipment.; 2020. http://www.dda.gov.np/content/health-technology-product-an-medical-device-directive-2074.
25. Cosmetic Devices and Drug Regulatory Authority (CDDA)- Sri Lanka. Guideline for Registration of Medical Devices in Sri Lanka.; 2011. https://nmra.gov.lk/images/PDF/guideline/guidelines_upload_2019_07_30/device_guideline_doc_05.pdf.
26. Case Reporting Form. https://nmra.gov.lk/index.php?option=com_contact&view=reporting&Itemid=191&lang=en. Accessed December 23, 2020.
27. Thailand government. Medical Device ACT, B.E. 2551 (2008).; 2008. https://www.fda.moph.go.th/sites/fda_en/Shared Documents/Med ACT_2008.pdf.
28. Thailand Medical Device Registration (Thai FDA) | Morulaa. https://morulaa.com/thailand-food-and-drug-administration-thai-fda/. Accessed October 13, 2020.
29. Food and drug Administration Ministry of Public Health. Guidance for Medical Device Industry.; 2018. http://thaihpvc.fda.moph.go.th/thaihvc/Public/News/uploads/hpvc_1_2_0_100728.pdf.
30. Mohiuddin A. An A-Z Pharmaceutical Industry: Bangladesh Perspective. Asian J Res Pharm Sci. 2019;9(1):17. doi:10.5958/2231-5659.2019.00004.3
31. Umar BU, Haque M. Adverse drug reactions in Bangladeshi health care setup: An update. Res J Pharm Technol. 2015;8(11):1598-1602. doi:10.5958/0974-360X.2015.00287.5
32. Gomez AL, Venkatesh DN, Neelakandan N. A comparative study of medical device regulations in India: Before and after the implementation of medical device rules 2017. Res J Pharm Technol. 2020;13(9):4423. doi:10.5958/0974-360x.2020.00782.9
33. George B. Registration of Medical Devices. Indian Soc Clin Res. 2010;1(3):90-93. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146078/.
34. M. D, N. J, M. V. Materiovigilance Programme of India – An Overview. Res J Pharm Technol. 2021;14(2):1137-1141. doi:10.5958/0974-360X.2021.00204.3
35. Cell S. Central Drugs Standard Control Organization. 2013:1-108. http://www.cdsco.nic.in/html/GCP1.html.
36. Raghotham S, Balamuralidhara V, Malhotra S. ‘SUGAM’ pathway for pharmaceutical products in India: An easy approach. Res J Pharm Technol. 2018;11(10):4635-4639. doi:10.5958/0974-360X.2018.00847.8
37. Khairnar A, Gade PR. Interventional improvement in hospital based intensive monitoring of adverse event. Res J Pharm Technol. 2011;4(9):1443-1448.
38. export.gov. https://www.export.gov/apex/article2?id=Nepal-Medical-Equipment-and-Drugs-and-Pharmaceuticals. Accessed October 18, 2020.
39. Guidance for Adverse Event Report from “Achieving Guidance in Clinical Trial Safety Information among Stakeholder” Forum for Ethical Review Committee in Thailand (FERCIT). https://www.fda.moph.go.th/sites/FDA_EN/SitePages/Medical.aspx?IDitem=index.
40. List of Countries without Formal Regulatory Approval Process | RegDesk. https://www.regdesk.co/countries-no-medical-device-regulations/. Accessed October 18, 2020.
41. Timor-Leste: Better Medical Supply Management Improves Lives. https://www.worldbank.org/en/news/feature/2015/01/08/timor-leste-better-medical-supply-management-improves-lives. Accessed October 18, 2020.
42. Uppsala Monitoring Centre. Being a member of the WHO Programme for International Drug Monitoring. 2014:2. https://www.who-umc.org/media/1434/being-a-member.pdf.