Medical Devices
CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality
We are very pleased to announce that CIRS Europe has been shortlisted for two Export Industry Awards by the Irish Exporters Association: Export Innovation of the Year; and Services Exporter of the Year (sponsored by Business Post). The Irish Exporters Association is the voice of the Export Industry in Ireland. It announced that 70 entries had been shortlisted for the 2023 Export Industry Awards across ten categories.
On May 10, 2023, we celebrated the grand opening of CIRS Kexin Biotech.* It has taken more than one year of industrial surveys but we were proud to finally open the new company on May 10, 2023.
On May 9, 2023, Hangzhou C&K Testing Technic Co., Ltd. (C&K Testing), a wholly-owned subsidiary of CIRS Group celebrated its tenth anniversary.
Our Global Cosmetics Regulation Conference held on April 25, was a resounding success, with delegates from across the cosmetics industry in attendance. We had a packed schedule with presentations from our Europe, South Korea, and US teams on cosmetics regulations in China, South Korea, the US, and the EU. The speakers provided an overview of the regulatory frameworks, including recent updates and challenges. The presentations were insightful and gave attendees a better understanding of the different regulations across various regions. The feedback from the attendees has been overwhelmingly positive, with many commenting on how insightful, and beneficial they found both the presentations as well as the opportunity to network with other professionals in the industry, in order to share experiences, and discuss the challenges and opportunities they currently face. We look forward to making this an annual event and bringing together professionals from the cosmetics industry to share insights and best practices.
CIRS Testing Korea (YU) has been accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 and is qualified to provide physical and chemical properties testing as well as hazardous substances analysis, which are necessary for substance registration and K-BPR notification.
In this webinar, we will summarize the regulation updates and regulatory activities in 2022, to assist the companies keep up with the new regulation updates and know more about how to register the medical device under the new regulations.
Policy Interpretation – How to Enter the "Fast Track" of Priority Approval? ——This policy was implemented on January 1, 2017 1. Scope of priority approval Projects those are applicable to the priority approval of "fast track" a. Applications for registration of domestic Class III medical devices. b. Applications for registration of imported Class II and Class III medical devices. Projects those are not applicable to the "fast track" of Priority Approval a. Filing of Class I medical devices; b. Applications for registration renewal and registration change; c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices. 2. The conditions for applying for priority approval (1) Diagnose or treat rare diseases, with obvious clinical advantages. (2) Diagnose or treat malignant tumors, with obvious clinical advantages. (3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments. (4) Dedicated to children, with obvious clinical advantages. (5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China. (6) Medical devices listed in major national science and technology projects or national key research and development programs. (7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate. 3. When is the priority approval application submitted? Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.
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.