Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science
Nanomaterials and nanotechnology are emerging as promising strategies for medical devices due to their advantageous properties, including the ability to effectively interact with biomolecules and tissues, as well as enhance therapeutic efficacy and biocompatibility. This has resulted in approved and...
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| Format: | Article |
| Language: | English |
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KeAi Communications Co., Ltd.
2025-06-01
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| Series: | Bioactive Materials |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2452199X25000659 |
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| author | Chubing Lin Xin Huang Yueguang Xue Shasha Jiang Chunying Chen Ying Liu Kuan Chen |
| author_facet | Chubing Lin Xin Huang Yueguang Xue Shasha Jiang Chunying Chen Ying Liu Kuan Chen |
| author_sort | Chubing Lin |
| collection | DOAJ |
| description | Nanomaterials and nanotechnology are emerging as promising strategies for medical devices due to their advantageous properties, including the ability to effectively interact with biomolecules and tissues, as well as enhance therapeutic efficacy and biocompatibility. This has resulted in approved and candidate devices in fields, such as orthopedics, dentistry, wound care, and neurology. However, the overall progress in translating medical devices using nanomaterials has been relatively slow, highlighting the urgent need to advance regulatory science. Regulatory authorities and organizations, such as the National Medical Products Administration in China and the European Union, have issued essential guidance documents for these devices' safety and efficiency evaluation. These documents include special requirements and considerations for physicochemical characterization, biological evaluation, and other aspects. Although some evaluation paths have been defined, ongoing advancements in technologies and methods are expected to enhance safety evaluation practices, reduce burdens on the medical device industry, and accelerate the clinical translation of medical devices using nanomaterials. Herein, we review the current state of regulatory science related to medical devices using nanomaterials, suggest the feasibility of using in vitro alternative methods to advance regulatory science, and offer forward-looking insights to inspire new ideas and technologies for accelerating clinical translation. |
| format | Article |
| id | doaj-art-dedcdb0c8a1f4cc3b1adbc3a53587db8 |
| institution | OA Journals |
| issn | 2452-199X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | Bioactive Materials |
| spelling | doaj-art-dedcdb0c8a1f4cc3b1adbc3a53587db82025-08-20T02:12:10ZengKeAi Communications Co., Ltd.Bioactive Materials2452-199X2025-06-014835336910.1016/j.bioactmat.2025.02.017Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory scienceChubing Lin0Xin Huang1Yueguang Xue2Shasha Jiang3Chunying Chen4Ying Liu5Kuan Chen6School of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, ChinaSchool of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, ChinaSchool of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, ChinaThe 990th Hospital of the Jointservice Support Force of the PLA, Zhumadian, Henan province, 463000, ChinaCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, ChinaCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, China; Corresponding author.Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100076, China; Corresponding author.Nanomaterials and nanotechnology are emerging as promising strategies for medical devices due to their advantageous properties, including the ability to effectively interact with biomolecules and tissues, as well as enhance therapeutic efficacy and biocompatibility. This has resulted in approved and candidate devices in fields, such as orthopedics, dentistry, wound care, and neurology. However, the overall progress in translating medical devices using nanomaterials has been relatively slow, highlighting the urgent need to advance regulatory science. Regulatory authorities and organizations, such as the National Medical Products Administration in China and the European Union, have issued essential guidance documents for these devices' safety and efficiency evaluation. These documents include special requirements and considerations for physicochemical characterization, biological evaluation, and other aspects. Although some evaluation paths have been defined, ongoing advancements in technologies and methods are expected to enhance safety evaluation practices, reduce burdens on the medical device industry, and accelerate the clinical translation of medical devices using nanomaterials. Herein, we review the current state of regulatory science related to medical devices using nanomaterials, suggest the feasibility of using in vitro alternative methods to advance regulatory science, and offer forward-looking insights to inspire new ideas and technologies for accelerating clinical translation.http://www.sciencedirect.com/science/article/pii/S2452199X25000659NanomaterialsMedical deviceRegulatory scienceSafety and efficiency evaluationIn vitro alternative |
| spellingShingle | Chubing Lin Xin Huang Yueguang Xue Shasha Jiang Chunying Chen Ying Liu Kuan Chen Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science Bioactive Materials Nanomaterials Medical device Regulatory science Safety and efficiency evaluation In vitro alternative |
| title | Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science |
| title_full | Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science |
| title_fullStr | Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science |
| title_full_unstemmed | Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science |
| title_short | Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science |
| title_sort | advances in medical devices using nanomaterials and nanotechnology innovation and regulatory science |
| topic | Nanomaterials Medical device Regulatory science Safety and efficiency evaluation In vitro alternative |
| url | http://www.sciencedirect.com/science/article/pii/S2452199X25000659 |
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