Practice and Exploration of Uniformity about Medical Device Evaluation Criterion

doi:10.19803/j.1672-8629.2021.11.01

Abstract

Abstract: Objectiv eTo outline the practice and exploration carried out by the Center for Medical Device Evaluation, NMPA(CMDE) in the unified evaluation criterion so as to provide a reference for relevant parties. Methods The existing problems in the system and the measures taken were analyzed, and the case of uniformity about medical device safety in CMDR was introduced. Results The CMDE further improved the quality management system, and carried out a number of useful explorations on the unified evaluation scale. Conclusion The unification of criterion is an important basis for ensuring the stability and repeatability of the evaluation, and the improvement of the system can effectively promote the unification of the evaluation criterion.

Key words: medical device, evaluation, criterion

CLC Number:

R994.1

ZHANG Shiqing, WANG Yingjun. Practice and Exploration of Uniformity about Medical Device Evaluation Criterion[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1001-1003.

References

[1] Zhang SQ, Qian H, Li YH.Discussion on quality management system construction for evaluation of medical devices[J]. Chinese Journal of Medical Instrumentation(中国医疗器械杂志), 2018, 42(4): 276-278.
[2] Zhang SQ, Sun JY, Xu L, et al.Discussion on science about medical device evaluation[J]. China Medical Device Information(中国医疗器械信息), 2020, 26(7): 1-4.
[3] Bai YL, Gao YF, Zhong HB, et al.Allogeneic and xenogeneic tissue repair materials: how to choose a suitable virus inactivation process[J]. Chinese Journal of Tissue Engineering Research(中国组织工程研究), 2019, 23(14): 2261-2268.
[4] Zhong HB, Bai YL, Zhao YT, et al.Influence of 75％ ethanol ultras-onic cleaning process on performance of human demineralized bone matrix[J]. Chinese Journal of Bone and Joint Injury(中国骨与关节损伤杂志), 2015, 30(12): 1296-1298.
[5] Wang JF, Ying ZF, Xu KW, et al.Develop avalidation test for pseudorabies viruses inactivation in keratoprosthesis by irradiation method[J]. Progress in Microbiology and Immunology(微生物学免疫学进展), 2018, 46(4): 40-43.
[6] Qing LF, Wei M, Yang PH, et al.Mechanism ofγ-irradiated food sterilization and microbial detection[J]. Food Research and Development(食品研究与开发), 2016, 37(5): 218-220.
[7] Zhao YT, Liu SY, Yin HQ, et al.Effects of terminal γ-ray irradiation sterilization on the viral inactivation and biomechanical property of the tendon allograft[J]. Chinese Journal of Bone and Joint(中国骨与关节杂志), 2018, 7(5): 389-393.
[8] Wang DW, Zhang B, Zhang L, et al.Analysis of evaluation standards and requirements for sterile medical devices packaging[J]. Plastics Packaging(塑料包装). 2020, 30(6): 1-4.
[9] Wang CR, Xu W.General aging theory and method for accelerated aging of medical devices[J]. China Medical Device Information(中国医疗器械信息), 2008, 14(5), 67-60.
[10] Pei XH.Selection of packaging materials for terminally sterilized medical devices[J]. China Medical Device Information(中国医疗器械信息), 2011, 17(8): 14-15.
[11] Jia JX.Discussion on verification for shelf life of non-active implantable medical device[J]. China Medical Device Information(中国医疗器械信息), 2011, 17(11): 14-17.

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