On May 21, 2025, Rui Enni, together with DNV and Zhongjian Huatongwei, held a special seminar on "Challenges and Opportunities of Active Medical Aesthetics Products under MDR Regulations" at Shenzhen Xili (Huatongwei Laboratory).During the meeting, Mr. Wang Hailong, the founder of Rui En Ni, brought the clinical trial design points and case sharing of MDR Annex XVI products to many students. The product definition of MDR Annex XVI is: products for unexpected medical purposes; The products listed as examples in this appendix are classified as non regulatory products under MDD, so this type of product needs to undergo clinical trials to verify its safety and effectiveness under MDR. After the meeting, Mr. Wang Hailong provided detailed answers to many students' questions about the clinical trial of Annex XVI type products, and received high praise from many students!      

CMEF (full name: China International Medical Equipment Fair) was founded in 1979. After more than 40 years of accumulation and precipitation, the exhibition has now developed into a medical equipment fair in the Asia Pacific region that integrates the entire medical equipment industry chain, product technology, new product launches, procurement and trade, brand promotion, scientific research cooperation, academic forums, and education and training. Its aim is to promote the healthy and rapid development of the medical equipment industry. The exhibition covers the entire medical device industry chain, integrates product technology, new product launches, procurement and trade, brand communication, scientific research cooperation, academic forums, education and training, and is an internationally leading global comprehensive service platform.  This time, Rui Enni and its subsidiary Guangzhou Zhuyi Tong will join forces at booth 8.1C07 in Hall 8. Welcome everyone to visit the booth for exchange, guidance, and cooperation negotiations!!  

CMEF (full name: China International Medical Equipment Fair) was founded in 1979. After more than 40 years of accumulation and precipitation, the exhibition has now developed into a medical equipment fair in the Asia Pacific region that integrates the entire medical equipment industry chain, product technology, new product launches, procurement and trade, brand promotion, scientific research cooperation, academic forums, and education and training. Its aim is to promote the healthy and rapid development of the medical equipment industry. The exhibition covers the entire medical device industry chain, integrates product technology, new product launches, procurement and trade, brand communication, scientific research cooperation, academic forums, education and training, and is an internationally leading global comprehensive service platform.  This time, Rui Enni and its subsidiary Guangzhou Zhuyi Tong will join forces at booth R05 in Hall 14. Welcome everyone to visit the booth for exchange, guidance, and cooperation negotiations!! And I will bring you the regulatory sharing of Saudi SFDA in Conference Room 13A (starting from 14:15 on September 12th).

Renni's subsidiaries (Guangzhou Zhuyitong&Hunan Boshu) have received their second thank-you letter for the clinical trial project, following the first one from the adaptive hearing aid clinical trial project. This is the second thank-you letter received in six months. As a service organization, receiving a written thank-you letter from a customer is no different from the joy and sense of honor that a hospital feels when it receives a banner from a patient.The client is a high-tech enterprise located in Dongguan City, specializing in the research and development, production, and sales of medical beauty equipment. The customer has an independent production park and has a very positive value system for product quality and business operations. At the beginning of the cooperation between the two parties, through talks, they determined that their values and beliefs were in line, and thus reached a cooperation agreement. This client was our first customer to sign a registration and clinical contract for radiofrequency therapy equipment, but due to their rigorous pursuit of product quality, it became the third project in terms of implementation sequence for radiofrequency skin therapy equipment. Internally, we refer to it as customer number 3.During the implementation of client 3's project, several challenging and key points were identified, including the following:1) Compatible with registration requirements in China, Europe, and AmericaDue to the client's expected markets being China, the European Union, and the United States. At the beginning of the clinical trial design, the differences in skin color between European, American, and Chinese populations were taken into account, as well as the cost factors of the enterprise. When conducting clinical trials in China, in addition to type III and IV skin, subgroups were specifically set up to include subjects with type I and type II skin tones. This kind of clinical cross-border compatibility design, which is one of the few in China, not only reflects our cost saving awareness for customers, but also demonstrates our courage to innovate and our ability to meet sufficient challenges.2) Urgent enrollment requirementsDue to the relatively late start of the project and pressure from industry peers. Customer 3 is very urgent about the speed of joining the team, and the key is that this project also needs to include some sub group races (Type I and Type II skin colors). The pressure to enroll subgroups (type I and type II skin color) was entirely placed on clinical trial bases in first tier cities. In order to accelerate enrollment, we collaborated with professional recruitment companies, foreigner associations, and research centers to conduct recruitment across three cities: Shenzhen, Dongguan, and Guangzhou. Finally, with the strong cooperation of the research center, SMO company, and various parties, the enrollment of Chinese people was completed ahead of schedule (with a maximum of more than 20 cases enrolled in one day at a time), and the enrollment of subgroups (type I and type II skin color) was completed on schedule.3) Stable research processBased on the clinical trial experience accumulated from the radiofrequency skin therapy devices of customers 1 and 2, we have continuously optimized the clinical trial plan, improved SOP, cultivated the operation and implementation team, planned various contingency plans, and successfully completed the enrollment, implementation, and exit of the clinical trial with skilled clinical trial researchers and blind reviewers.4) Good clinical qualityDuring the clinical trial, client 3 commissioned relevant parties to conduct a comprehensive inspection of the clinical trial process at two research centers. Due to our rich clinical practice experience and extensive GCP experience prior to this, our inspection has achieved relatively good results.Based on the above main points, Customer 3 is very satisfied with the entire collaboration and clinical trial project. Of course, we were fortunate to receive a written thank-you letter from the customer unexpectedly. For service-oriented enterprises, this honor is a more generous and important reward and affirmation than economic rewards. Zhuyitong has several mature clinical trial experiences in radiofrequency skin therapy products, making it one of the most abundant clinical CROs in South China. At the same time, Zhuyitong has also conducted clinical trial projects on hair removal devices and subcutaneous fillers, gaining certain experience in the field of medical aesthetics.In the future, Zhuyitong will continue to strengthen self-learning, accumulate project experience, improve project management, and steadily advance on the path of clinical trials, striving to do better and for a longer period of time......

To all dear customersThe 88th China International Medical Equipment Fair (CMEF) will be held from October 28th to 31st, 2023, at the Shenzhen International Convention and Exhibition Center (Bao'an Hall).Rui Enni's booth is located at booth 10C52 in Hall 10 of the Comprehensive Exhibition Center (on the right side of the South Login Hall) (next to the elevator on the right side of Hall 10). At this exhibition, Rui Enni, together with Guangdong Huaguang and Guangzhou Zhuyi Tong, sincerely invites you to visit our booth to exchange guidance and learn from the event. At the same time, Rui Enni also collaborated with the Medical Device Branch of the China Association for Quality and Safety Promotion of Food and Drug Enterprises and the National Medical Products Exhibition to hold the third "Global Medical Device Regulations Forum" in Conference Room 14A on the second floor of Hall 14-16. Rui Enni and Zhuyitong respectively explained the topics of "IVDR Application Strategy and Regulatory Update" and "Clinical Trial Project Management of Medical Devices in China, Europe and America", bringing new technical content sharing to everyone. CMEF简介

The 88th China International Medical Equipment Fair (CMEF) successfully concluded on October 31, 2023 at the Shenzhen International Convention and Exhibition Center (Bao'an Hall).Ryan Ni has been invited to participate in the exhibition. We would like to express our sincere gratitude to the customers, colleagues, and friends who have been present at the event for their strong support of Ryan Ni. We also appreciate the high attention and recognition from relevant industry professionals. 　At the same time, Ruini also collaborated with the Medical Device Branch of the China Association for the Promotion of Quality and Safety of Food and Drug Enterprises and the National Medical Products Exhibition to hold the third "Global Medical Device Regulations Forum" in Conference Room 14A on the second floor of Hall 14-16. Ruini and Zhuyitong respectively explained two topics, "IVDR Application Strategy and Regulatory Update" and "Clinical Trial Project Management of Medical Devices in China, Europe, and America", providing students with different regulatory courses and learning experiences.