Solution to Unify the Review of Domestic Second Class Medical Device / 中国医疗器械杂志

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.

Feasibility Research of Determined Oxygen Permeability of Finished Soft Contact Lens / 中国医疗器械杂志

<p><b>OBJECTIVE</b>A method for determined oxygen permeability (Dk) of finished soft contact lens.</p><p><b>METHODS</b>Oxygen permeability(Dk) of 10 group finished soft contact lens was determined by polarographic method, and the values were linearly calibrated using the measured and established Dk values of the specified reference materials.</p><p><b>RESULTS</b>Only one Dk value fell outside of the requirement of GB 11417.3-2012 tolerance for Dk (± 20%).</p><p><b>CONCLUSION</b>It is great practicability when determined the oxygen permeability (Dk) of finished soft contact lens by polarographic method which were linearly calibrated using the measured and established Dk values of the specified equal thickness reference materials without the measured lens customized 4 different thickness.</p>

How to improve the accreditation validity of medical devices testing laboratory / 中国医疗器械杂志

The safety and effectiveness of medical devices are directly related to human health. Therefore, how to improve the accreditation validity of medical devices testing laboratory has been the focus of attention from every corner of society. With respect to the characteristics of medical devices testing laboratory, this paper represented the existing issues during the accreditation and evaluation of testing laboratory, put forward some improvement suggestions on how to improve the validity of testing laboratory evaluation based on the practical experience.

Spectrophotometric study of Poloxamer in contact lens care solution / 上海交通大学学报（医学版）

Objective To determine the contents of Poloxamer in contact lens care solution by spectrophotometric method,and investigate the effect of the other lubrication composition on the measurement. Methods Five brands of contact lens care solution with hydroxypropyl methyl cellulose(HPMC)were obtained.The interference of HPMC in contact lens care solution was removed by heating and rapid filtering,and the contents of Poloxamer was determined by KI-I_2 spectrophotometry. Results For the pre-treated contact lens care solution,the tested wavelength was 500 nm and the development time was 120 min.Favourable linearity was observed when Poloxamer ranged between 0.001 mg/mL and 0.020 mg/mL,with standard curve of Y=0.050 91X+0.017 15 and r~2=0.998 2.Precision(n=6)test revealed that RSD was 1.331 4%,and RSD of daytime repeatability experiment was 2.971 3%.The recovery rates of 80%,100%and 120% samples ranged between 90%to 105%. Conclusion KI-I_2 spectrophotometry is a convenient,stable and reliable method,and may sere as a mass control method for nonionic surfactant Poloxamer content in contact lens care solution.