移动 CT 脑卒中救护车，是为帮助脑卒中患者跑赢时间，提高脑卒中患者急救成功率所配置的专业救护车。本车采用进口依维柯底盘专业改装而成，配备全球唯一可移动式小型工作 CT，可进行平扫、轴扫、螺旋扫、动态扫描；可无线传输图像，配备碳纤维可透射线扫描板，简单、快速的工作模式使移动 CT 满足对脑卒中诊断的紧迫时间要求，为诊断提供清晰准确的影像依据。CT 影像通过远程设备传输到医生处进行诊断，配合车内各项血气分析及监护装备，脑卒中患者第一时间可在移动 CT 脑卒中救护车内进行血气分析，并进行溶栓或初步治疗，极大缩短确诊时间，加快溶栓及治疗进度。移动 CT 脑卒中救护车将扫描、诊断、溶栓提前到了院前，极大地降低了死亡率及致残率。
F A Q
Is it legal for manufacturers to cope with issues of initial registration without an agent ?
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.
How long is the NMPA review process for the initial registration of the medical device ?
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.
In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?
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.
Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?
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.