Research on Classification of Medical Devices with Nanomaterials
The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | zho |
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Editorial Office of Chinese Journal of Medical Instrumentation
2025-05-01
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| Series: | Zhongguo yiliao qixie zazhi |
| Subjects: | |
| Online Access: | https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240600 |
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| _version_ | 1850207595207327744 |
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| author | Qian DONG Li YI Liyin WEN Rui LIU Jinglong TANG Jiong ZHU |
| author_facet | Qian DONG Li YI Liyin WEN Rui LIU Jinglong TANG Jiong ZHU |
| author_sort | Qian DONG |
| collection | DOAJ |
| description | The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China’s medical device regulation. |
| format | Article |
| id | doaj-art-2255c1925d534da99aa534695cb4a631 |
| institution | OA Journals |
| issn | 1671-7104 |
| language | zho |
| publishDate | 2025-05-01 |
| publisher | Editorial Office of Chinese Journal of Medical Instrumentation |
| record_format | Article |
| series | Zhongguo yiliao qixie zazhi |
| spelling | doaj-art-2255c1925d534da99aa534695cb4a6312025-08-20T02:10:28ZzhoEditorial Office of Chinese Journal of Medical InstrumentationZhongguo yiliao qixie zazhi1671-71042025-05-0149333633910.12455/j.issn.1671-7104.2406002024-0600Research on Classification of Medical Devices with NanomaterialsQian DONG0Li YI1Liyin WEN2Rui LIU3Jinglong TANG4Jiong ZHU5National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing, 102629The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China’s medical device regulation.https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240600nanomaterialsmedical deviceclassification |
| spellingShingle | Qian DONG Li YI Liyin WEN Rui LIU Jinglong TANG Jiong ZHU Research on Classification of Medical Devices with Nanomaterials Zhongguo yiliao qixie zazhi nanomaterials medical device classification |
| title | Research on Classification of Medical Devices with Nanomaterials |
| title_full | Research on Classification of Medical Devices with Nanomaterials |
| title_fullStr | Research on Classification of Medical Devices with Nanomaterials |
| title_full_unstemmed | Research on Classification of Medical Devices with Nanomaterials |
| title_short | Research on Classification of Medical Devices with Nanomaterials |
| title_sort | research on classification of medical devices with nanomaterials |
| topic | nanomaterials medical device classification |
| url | https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240600 |
| work_keys_str_mv | AT qiandong researchonclassificationofmedicaldeviceswithnanomaterials AT liyi researchonclassificationofmedicaldeviceswithnanomaterials AT liyinwen researchonclassificationofmedicaldeviceswithnanomaterials AT ruiliu researchonclassificationofmedicaldeviceswithnanomaterials AT jinglongtang researchonclassificationofmedicaldeviceswithnanomaterials AT jiongzhu researchonclassificationofmedicaldeviceswithnanomaterials |