Objective: To discuss the main points of revision of relevant regulations for sampling inspection of medical devices. Methods: New situation of medical device regulation, especially sampling inspection was sorted out. Shortcomings and problems of the current regulations for sampling inspection of medical devices were summarized. Feasibility and impact of major feasible aspects were analyzed. Results: Some suggestions for revising the Regulations for Sampling Inspection of Medical Devices were put forward. Conclusion: Regulator authorities should be well aware of the current changes in the regulatory situation of medical devices, timely summarize the lessons learned, adjust the positioning and take the initiative, put the revisions of the relevant regulations on sampling inspection of medical devices on the agenda.
Hao Qing, Zhang Xintao, Zhu Ning, Zhu Jiong, Li Xiao
. On Revision of Regulation for Sampling Inspection of Medical Devices under the New Situation[J]. Chinese Pharmaceutical Affairs, 2019
, 33(12)
: 1391
-1394
.
DOI: 10.16153/j.1002-7777.2019.12.009
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