Regulatory requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union
Abstract
Understanding and observing regulatory norms is essential for the development and commercialization of medical devices. To assure the operation, safety, and effectiveness of medical devices while minimizing adverse effects, strict regulatory criteria are required as their use grows. The ability to offer the essential direction for proper registration by pertinent authorities, manufacturers, and importers has been made possible by recent recommendations. Medical device rules are now being implemented in many nations. Converging rules are essential to reduce regulatory barriers and speed up access to high-quality, secure, and effective medical devices since different countries and regions have different laws governing medical devices. The Global Harmonisation Task Force (GHTF), which strives to harmonise medical device regulatory regulations, is comprised of the majority of nations. Medical device regulations that are more uniform will make high-quality products more widely available. This article discusses the definition of a medical device in each of these areas, and it does so in the order of their proportion of the global market share. In this article, we looked at how major economies throughout the world regulate medical devices. This article's objective is to give a thorough review of the legal systems that govern the registration of medical devices in the European Union, the United States, and the Kingdom of Saudi Arabia. The current article discusses the classification of medical devices in the Kingdom of Saudi Arabia, the United States, and the European Union, as well as the registration procedure for medical devices.
Keywords:
Global Harmonisation Task Force (GHTF), Saudi Food and Drug Authority (SFDA), United States Food and drug Administration (USFDA), European Commission, Medical devices
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References
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2. How to Determine if Your Product is a Medical Device [Internet]. USFDA; 2022 Sept 29 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
3. Medical Device Registration in Saudi Arabia [Internet]. Operon Strategist; 2018 July 05. [cited 2023 Apr 21]. Available from:
https://operonstrategist.com/medical-device-registration-in-saudi-arabia/
4. SFDA medical device registration in Saudi Arabia [Internet]. Emergo by UL; 2023 [cited 2023 Apr 21]. Available from:
https://www.emergobyul.com/
5. How to Study and Market Your Device Medical devices marketed in the United States are subject to the regulatory controls (/regulatory-controls-medical-devices) in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21-Code of Federal Regulations [Internet].USFDA; 2022 Oct 03[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device
6. A History of Medical Device Regulation & Oversight in the United States [Internet]. USFDA; 2019 Jun 24[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
7. Chen YJ, Chiou CM, Huang YW, Tu PW, Lee YC, Chien CH. A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan. Vol. 52. Therapeutic Innovation and Regulatory Science. SAGE Publications Inc.; 2018. .p.62-9.
8. SFDA Medical Device Registration in Saudi Arabia (2022 Guide) [Internet]. Pharmaknowl Consulting; 2023 Apr 24 [cited 2023 Apr 21]. Available from:
https://pharmaknowl.com/sfda-medical-devices-registration-saudi-arabia/
9. Low. Classication of Medical Device and Premarket Approval Process [Internet]. RegDesk; 2023 Mar 30 [cited 2023 Apr 21]. Available from:
https://www.regdesk.co/resource-library/saudi-arabia/2/5
10. Saudi FDA Products Classification Guidance [Internet]. SFDA; 2023[cited 2023 Apr 21]. Available from:
www.sfda.gov.sa
11. Medical Devices Regulatory Services in Saudi Arabia Overview [Internet]. Global Medical Device Regulatory Services; 2008 [cited 2023 Apr 21]. Available from:
https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-saudi-arabia
12. Seidenfaden M. Market Access of Medical Devices Saudi Arabia [Internet]. Johner Institute; 2020 Aug 06. [cited 2023 Apr 21]. Available from:
https://www.johner-institute.com/articles/regulatory-affairs/and-more/saudi-arabia-is-it-worth-having-your-medical-devices-authorized/
13. Prüfungsarbeit W, Des Titels E, Samadi F. Regulatory requirements of Medical Devices in MENA countries. DGRA Master of Drug Regulatory Affairs; 2015 Feb.p. 23-25.
14. Classify Your Medical Device [Internet]. USFDA; 2020 Feb 07 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
15. Medical Device Classification Product Codes Guidance for Industry and Food and Drug Administration Staff Document [Internet]. Regulation.gov; 2013 Apr 11 [cited 2023 Apr 21]. Available from:
http://www.regulations.gov
16. Premarket Notication 510(k) [Internet]. USFDA; 2022 Oct 03 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
17. 510(k) Submission Process [Internet]. USFDA; 2022 Oct 03 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
18. 510(k) Submission Programs [Internet]. USFDA; 2019 Sep 12 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs
19. PMA Approvals General Information Searching the Releasable PMA Database PMA Files for Downloading Monthly PMA/ PDP Decisions and Summary Statistics Other Resources General Information [Internet]. USFDA; 2021 Dec 16 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals
20. Overview of IVD Regulation [Internet]. USFDA; 2021 Oct 18 [cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
21. Device Labeling Introduction to Medical Device Labeling [Internet]. USFDA; 2020 Oct 23[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
22. Guidance on Requirements for Medical Device Listing and Marketing Authorization [Internet]. SFDA; 2020 [cited 2023 Apr 21]. Available from:
https://www.sfda.gov.sa/sites/default/files/2020-07/MDS-G5.pdf
23. FDA’s Role in Regulating Medical Devices [Internet]. USFDA; 2018 Aug 31 [cited 2023 Apr 22]. Available from:
https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices
24. Postmarket Requirements (Devices) Spotlight Guidance Documents (Medical Devices and Radiation-Emitting Products) Radiation-Emitting Products. National Evaluation System for Health Technology (NEST), Recalls & Alerts List of Device Recalls [Internet]. US FDA; 2018 Sep 27[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices
25. Device Registration and Listing [Internet]. USFDA; 2022 Oct 05[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
26. Post-Approval Studies Program Guidance Document: Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Order. GAO Report: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing Post-Approval Studies Database Go to the Database [Internet]. USFDA; 2022 Oct 06[cited 2023 Apr 21]. Available from:
https://www.fda.gov/medical-devices/postmarket-requirements-devices/post-approval-studies-program
27. Food And Drug Administration Compliance Program Guidance Manual Program 7382.845 Subject: Inspection of Medical Device Manufacturers Implementation [Internet]. Registrar Corp; 2023 [cited 2023 Apr 21]. Available from:
https://www.registrarcorp.com/fda-food/food-safety/
28. Regulation (Eu) 2017/ 745 of the European Parliament and Of the Council - of 5 April 2017 – on medical devices, amending Directive 2001/ 83/ EC, Regulation (EC) No 178/ 2002 and Regulation (EC) No 1223/ 2009 and repealing Council Directives 90/ 385/ EEC and 93/ 42/ EEC. Official Journal of European Union; 2017 May 05.p.1-117.
29. Galgon RE. Understanding medical device regulation. Vol. 29, Current Opinion in Anaesthesiology. Lippincott Williams and Wilkins; 2016.p.703-10.
30. Kolankari P, Chakole U, Kulkarni M, Shariff AR. European Union-Medical Device Regulations Implications, and way forward [Internet]. 2020. [cited 2023 Apr 23]. Available from:
https://www.capgemini.com/wp-content/uploads/2020/06/PoV-EU-MDR-Implications-and-way-forward-18June.pdf
31. Europe CE Marking Regulatory Process for Medical Devices [Internet]. Emergo by UL; 2023 [cited 2023 Apr 22]. Available from:
https://www.emergobyul.com/resources/europe-ce-marking-regulatory-process-medical-devices
32. Sethi R, Popli H, Sethi S. Medical Devices Regulation in United States of America, European Union, and India: A Comparative Study. Pharmaceutical Regulatory Affairs. 2017;06(01).
33. European Union Medical Device Regulations [Internet]. RegDesk; 2023 [cited 2023 Apr 23]. Available from:
https://www.regdesk.co/resource-library/european-union/
34. Clemens N. “Happy Trials to You” The European Medical Device Regulation 2017/745/EU: Changes and Impact on Stakeholders [Internet]. wcg; Vol. 14. 2018 [cited 2023 Apr 21]. Available from:
www.firstclinical.com
35. Medical Devices: Guidance Document-Classification Of Medical Devices Guidelines Relating To The Application Of The Council Directive 93/42/EEC On Medical Devices. European Commission DG Health and Consumer Directorate B, Unit B2 “Cosmetics and Medical Devices”; 2010 Jun.p.1-51.
36. Germundsson F. MDR 2017/745-New EU Regulation for Medical Devices: A Process Description For EHR Manufacturers On How To fulfil The Regulation Frida Germundsson Nicole Kvist Kth Royal Institute Of Technology School Of Engineering Sciences in Chemistry, Biotechnology And Health [Internet]. KTH; 2023 [cited 2023 Apr 23]. Available from:
http://www.kth.se
37. Candarone Poster T. Labelling Regulatory Requirements for Medical Devices. US Department of Health and Human Services. Public Health Service US FDA; 1989. p. 1-42.
38. Manu M, Anand G. A review of medical device regulations in India, comparison with European Union and way-ahead. Perspectives in Clinical Research. Wolters Kluwer Medknow Publications. 2022;13:3-11.
39. Medical Device User Fees [Internet]. USFDA. 2022 Oct 05 [cited 2023 Apr 23]. Available from:
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees#fees
40. Premarket Approval (PMA) [Internet]. USFDA; 2019 May 16 [cited 2023 Apr 23]. Available from:
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
41. Medical Device Exemptions 510(k) and GMP Requirements [Internet]. Maryland USA: USFDA; 2023 May 22 [cited 2023 Apr 23]. Available from:
Medical Device Exemptions 510(k) and GMP Requirements (fda.gov)
42. GNK G, B. N, Vidhya LT. Medical Device Regulation in Us, Europe, China And India. Int J Drug Reg Affairs [Internet]. 2018Feb.14 [cited 2023Apr.2];5(2):17-5. Available from:
https://ijdra.com/index.php/journal/article/view/198
43. Payment Process FDA [Internet]. USFDA; 2017 Dec 23 [cited 2023 Apr 23]. Available from:
https://www.fda.gov/medical-devices/device-registration-and-listing/payment-process
44. Medical device - [Internet]. Wikipedia; 2022 Apr [cited 2023 Apr 23]. Available from:
https://en.wikipedia.org/wiki/Medical_device
45. Cheng Michael. Medical device regulations: global overview and guiding principles. Geneva Switzerland: World Health Organization; 2003.p.43.
46. Brolin S, Zhang L, Hamp S. Global Regulatory Requirements for Medical Devices. Mälardalen University Department of Biology and Chemical Engineering.p.5-61
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Bhaskar, R., M. Ola, S. S. Saharan, and V. Nikam. “Regulatory Requirements for Medical Device Registration in Kingdom of Saudi Arabia, US and European Union”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 75-85, doi:10.22270/ijdra.v11i2.605.
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