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On January 16, 2023, CIRS Group announced the opening of a new office in Shanghai, as it continues its expansion into the global market. Located in the heart of Pudong – Shanghai's central business district – the Shanghai Office will devote itself to providing timely and sound product compliance services and solutions to clients in Shanghai and the surrounding areas.
For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values. If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.
In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product. It must: clarify the hemostatic mechanism of the declared product in detail, describe how the product affects the hemostatic process, the advantages of the product in the hemostatic process, and confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable. The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.
On September 18, 2020, the National Medical Products Administration issued the Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China No.104 of 2020. The purpose was to further implement the State Council's Opinions on Reforming the Review and Approval System for Pharmaceutical and Medical Devices and Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices. As well as to implement the reform of "streamlined administration and delegated power, improve regulations, and upgrade services" and the requirements for optimizing the business environment, comprehensively deepening the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs. This article explains the announcement which covers the production of products with an imported medical device registration certificate in China:
Based on the current level of knowledge, biological tests can be exempted if the following conditions are satisfied: Material chemical composition verification data are provided. The production process does not affect the chemical composition of the material, verification data can be submitted in the form of a material list of raw materials. The materials used in surgical instruments that come into contact with patients (directly or indirectly) are only composed of metals. Metal materials are verified to meet the relevant national, industrial and international standards for metallic materials for surgical implants or materials for surgical instruments, as well as the brand specified in applicable national and industrial standards for specific products. For example, the material brand specified in YY/T 0176 General Technical Conditions for Medical Scissors.
1 Whether the non-Chinese clinical trial data of the product must fully meet the requirements of the corresponding Chinese guidelines or not? 2 Can I select similar products as the control products according to Chinese regulations? 3 Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data ? 4 Are the medical devices required to carry out clinical trials in China?
A single-group target value design can be considered when test device is technically mature and the disease for which it is intended is well understood, or when it is objectively infeasible to set up a control group We recommend choosing RCT trial design for clinical trial, according to technical development and clinical application status of intracranial drug-coated balloon dilatation catheter, which does not conform to the basic principle of single-group target value design.
When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify the applicability of anticoagulants and their impact on the test.
Registration applicants are required to provide research data on measurement accuracy and inform users in the instructions.
Recently, CIRS Group once again successfully helped clients complete a regular registration under MEE Order No. 12. And the results have been notified on the MEE website.
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