The second BodyTom® mobile CT in the Chinese People's Liberation Army General Hospital was successfully installed

2019-03-01 08:00

On February 28, 2019, the second BodyTom® of the Chinese People's Liberation Army General Hospital (Beijing 301 Hospital) was successfully installed in our hospital area! So far, 301 Hospital has installed 2 BodyTom® and 1 CereTom®, a total of 3 mobile CT equipment.

BodyTom® is used in the operating room of the inpatient building. Before the mobile ct configuration, it is an ordinary operating room; after the configuration, the hospital makes full use of the characteristics of the mobile ct to make it shuttle between the various operating rooms to meet the needs of hybrid operating rooms; at the same time, BodyTom® can perform preoperative and surgical procedures. Middle and post-operative tests can provide surgeons with more realistic pathological data; in addition, surgical patients no longer need to be transferred to the radiology department on the first floor of the outpatient building for testing, avoiding transfer risks and improving the quality of surgery.

The Chinese People’s Liberation Army General Hospital (301 Hospital) is a large-scale modern comprehensive hospital integrating medical treatment, health care, teaching, and scientific research. It has an annual emergency volume of more than 4.9 million people, accommodates 198,000 people, and operates nearly 90,000 cases. More patients provide better medical services. 301 Hospital always attaches importance to personnel training and the introduction of advanced technology and equipment, and has never stopped in the pursuit of making greater contributions to China's medical industry.

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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.

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.

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.

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.