Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advance...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-10-01
|
| Series: | Applied Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3417/14/20/9304 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850205768780873728 |
|---|---|
| author | Carolina Amaral Maria Paiva Ana Rita Rodrigues Francisco Veiga Victoria Bell |
| author_facet | Carolina Amaral Maria Paiva Ana Rita Rodrigues Francisco Veiga Victoria Bell |
| author_sort | Carolina Amaral |
| collection | DOAJ |
| description | Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). |
| format | Article |
| id | doaj-art-a5041d93b7914df5aef854c000ac9abc |
| institution | OA Journals |
| issn | 2076-3417 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Applied Sciences |
| spelling | doaj-art-a5041d93b7914df5aef854c000ac9abc2025-08-20T02:11:01ZengMDPI AGApplied Sciences2076-34172024-10-011420930410.3390/app14209304Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market AccessCarolina Amaral0Maria Paiva1Ana Rita Rodrigues2Francisco Veiga3Victoria Bell4Social Pharmacy and Public Health Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalSocial Pharmacy and Public Health Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalSocial Pharmacy and Public Health Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalDrug Development and Technology Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalSocial Pharmacy and Public Health Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalMedical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA).https://www.mdpi.com/2076-3417/14/20/9304medical deviceregulatory frameworkEuropean UnionUnited States of AmericaJapan |
| spellingShingle | Carolina Amaral Maria Paiva Ana Rita Rodrigues Francisco Veiga Victoria Bell Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access Applied Sciences medical device regulatory framework European Union United States of America Japan |
| title | Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access |
| title_full | Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access |
| title_fullStr | Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access |
| title_full_unstemmed | Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access |
| title_short | Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access |
| title_sort | global regulatory challenges for medical devices impact on innovation and market access |
| topic | medical device regulatory framework European Union United States of America Japan |
| url | https://www.mdpi.com/2076-3417/14/20/9304 |
| work_keys_str_mv | AT carolinaamaral globalregulatorychallengesformedicaldevicesimpactoninnovationandmarketaccess AT mariapaiva globalregulatorychallengesformedicaldevicesimpactoninnovationandmarketaccess AT anaritarodrigues globalregulatorychallengesformedicaldevicesimpactoninnovationandmarketaccess AT franciscoveiga globalregulatorychallengesformedicaldevicesimpactoninnovationandmarketaccess AT victoriabell globalregulatorychallengesformedicaldevicesimpactoninnovationandmarketaccess |