At the beginning of the new year, the US and China Mutual Benefit successfully obtained the exclusive national agency rights for EOS. On this occasion, the company's product department, marketing department, maintenance department, and sales department formed a small team together with Didier, general manager of EOS Asia-Pacific region, to visit Beijing Jishuitan Hospital, Nanjing Gulou Hospital, Shanghai Ruijin and other installed hospitals. Installed customers consistently highly affirmed EOS' clinical significance and product quality!
Jishuitan Hospital, the number one orthopedic hospital in the country, has been operating well in the past two years since its installation in 2017. Director Cheng of the imaging department gave a detailed introduction to the use of EOS in the hospital: on average, more than 100 patients benefited every day. The application of EOS in orthopedic and lateral spine and lower limbs, sports injuries, orthopedics, joint replacement sitting, pediatric orthopedics, etc. Is outstanding.
Professor Qiu Yong, director of the Orthopedics Department of Nanjing Gulou Hospital, shared use cases with Mr. Didier, and compared images to show the positive significance of EOS in clinical applications. The department is currently doing relevant clinical research. During the period, Professor Image Keshi personally led a tour of the computer room, shared EOS's requirements for the installation site, and gave suggestions and guidance on professional issues such as how to apply in multiple departments.
Director Zhang of Ruijin Hospital and Teacher Zhu from the imaging department of Ruijin Hospital shared the use of EOS in the hospital: In addition to orthopedics, rehabilitation patients also have a great demand for EOS. Compared with the current diagnostic equipment, EOS has incomparable clinical advantages and characteristics. Product advantages such as weight-bearing position, full body length, ultra-low dose, and powerful 3D workstation will help clinicians make more accurate clinical diagnosis and pre-operative planning, throughout the entire treatment process of patient diagnosis, surgery, and rehabilitation, giving the patient maximum Security.
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.
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