Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific
While some sort of regulatory convergence and harmonisation are often needed for achieving regulatory reliance, in reality, regulatory reliance as a strategy towards convergence and harmonisation has never been more significant in Asia-Pacific (APAC). A sustained, rapid and large-scale provision of...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Global Health |
| Online Access: | https://gh.bmj.com/content/7/8/e009798.full |
| _version_ | 1811283773771218944 |
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| author | Li Zhang Zhenyu Zhang Ming Xu Yangmu Huang Xiangning Feng |
| author_facet | Li Zhang Zhenyu Zhang Ming Xu Yangmu Huang Xiangning Feng |
| author_sort | Li Zhang |
| collection | DOAJ |
| description | While some sort of regulatory convergence and harmonisation are often needed for achieving regulatory reliance, in reality, regulatory reliance as a strategy towards convergence and harmonisation has never been more significant in Asia-Pacific (APAC). A sustained, rapid and large-scale provision of medical devices, including articles and apparatus used in diagnosis, care, treatment or prevention of disease and softwares, etc, across national boundaries, is the key to winning the fight against future pandemics and improving people’s well-being in such a populous and geographically diverse region. The COVID-19 pandemic highlighted the value of regulatory reliance to enable easier access to medical devices that have gone through regulatory approvals in countries with mature regulatory systems based on the Quality Management System and product assessment guidelines of the International Medical Device Regulators Forum. This analysis focuses on why regulatory reliance is needed, how much has been achieved, its impact on the development of the medical device industry and challenges to be addressed in the region. By drawing on the experience from the Singapore Health Sciences Authority–Thai Food and Drug Administration regulatory reliance pilot and Vietnam’s inclusion of Korea Ministry of Food and Drug Safety and China National Medical Products Administration as reference markets for fast review/approval, it aims to explore next viable steps and future trend of the APAC regional regulatory harmonisation mechanism through regulatory reliance in the post-COVID-19 era. |
| first_indexed | 2024-04-13T02:18:42Z |
| format | Article |
| id | doaj.art-f6b25adfc5764005a72ff771a07b7fc8 |
| institution | Directory Open Access Journal |
| issn | 2059-7908 |
| language | English |
| last_indexed | 2024-04-13T02:18:42Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Global Health |
| spelling | doaj.art-f6b25adfc5764005a72ff771a07b7fc82022-12-22T03:07:04ZengBMJ Publishing GroupBMJ Global Health2059-79082022-08-017810.1136/bmjgh-2022-009798Regulatory reliance for convergence and harmonisation in the medical device space in Asia-PacificLi Zhang0Zhenyu Zhang1Ming Xu2Yangmu Huang3Xiangning Feng4Department of Nephrology, Chinese PLA General Hospital, Beijing, China1 Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USADepartment of Medical Ultrasound, Division of Interventional Ultrasound, The First Affiliated Hospital, Sun Yat-sen University, ChinaDepartment of Global Health, School of Public Health, Peking University, Beijing, ChinaDepartment of Global Health, Peking University School of Public Health, Beijing, ChinaWhile some sort of regulatory convergence and harmonisation are often needed for achieving regulatory reliance, in reality, regulatory reliance as a strategy towards convergence and harmonisation has never been more significant in Asia-Pacific (APAC). A sustained, rapid and large-scale provision of medical devices, including articles and apparatus used in diagnosis, care, treatment or prevention of disease and softwares, etc, across national boundaries, is the key to winning the fight against future pandemics and improving people’s well-being in such a populous and geographically diverse region. The COVID-19 pandemic highlighted the value of regulatory reliance to enable easier access to medical devices that have gone through regulatory approvals in countries with mature regulatory systems based on the Quality Management System and product assessment guidelines of the International Medical Device Regulators Forum. This analysis focuses on why regulatory reliance is needed, how much has been achieved, its impact on the development of the medical device industry and challenges to be addressed in the region. By drawing on the experience from the Singapore Health Sciences Authority–Thai Food and Drug Administration regulatory reliance pilot and Vietnam’s inclusion of Korea Ministry of Food and Drug Safety and China National Medical Products Administration as reference markets for fast review/approval, it aims to explore next viable steps and future trend of the APAC regional regulatory harmonisation mechanism through regulatory reliance in the post-COVID-19 era.https://gh.bmj.com/content/7/8/e009798.full |
| spellingShingle | Li Zhang Zhenyu Zhang Ming Xu Yangmu Huang Xiangning Feng Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific BMJ Global Health |
| title | Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific |
| title_full | Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific |
| title_fullStr | Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific |
| title_full_unstemmed | Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific |
| title_short | Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific |
| title_sort | regulatory reliance for convergence and harmonisation in the medical device space in asia pacific |
| url | https://gh.bmj.com/content/7/8/e009798.full |
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