In 2017, the diagnostic equipment type medical device won the registration card competition
Medical News Network March 1 hearing about the medical equipment registered in the CFDA in 2017, before we have talked about diagnostic reagents, orthopedic equipment and infusion equipment, and now we talk about another area: the diagnosis of medical equipment .
Registered approvals increased by 40 over the same period of last year
There were 62 registration approvals for diagnostic equipment in 2017, an increase of 40 from the 22 in 2016. Among them, the proportion of domestic manufacturers and imported manufacturers each accounted for 31% of the total, and the number of imported manufacturers increased by 25 over 2016 .
Figure 1: Registration Comparison of domestic and foreign manufacturers
X-ray machine approved the most
according to medical instruments Category, Diagnostic Equipment Medical devices can be subdivided into diagnostic ultrasound imaging equipment, magnetic resonance imaging systems, and diagnostic X-ray machines. In 2017 SPECT (Single Photon Emission Computerized Tomography) was added.
A total of 31 approvals for diagnostic X-ray machines were approved in 2017, accounting for 50% of the total, followed by ultrasound imaging equipment, 18 approvals and 12 NMR.
Figure 2: Comparison of diagnostic equipment medical equipment classification
Foreign companies compete for approval
Manufacturers, Siemens Group (offshore) received the largest number of approvals, a total of 7. Including:
Siemens Medical Solutions USA, Inc. (the United States Siemens Medical Systems Co., Ltd.) of the three ultrasound diagnostic systems, registration number: State injection into the 20173231079, State equipment into the 20173231080, State equipment into 20173231081, and a positron Emission and X-ray computed tomography system (registration number: Guo-li injection into the 20173332264), also includes Siemens Mobile (Siemens AG) 2 mobile C-arm X-ray machine (State equipment into 20173301082 and the country Into the 20173301083) and a digital radiography system (digital X-ray fluoroscopy system).
Siemens diagnostic equipment in the country registered in 2016, only single-photon emission computed tomography system and two ultrasound systems, increased in 2017 a variety of X-ray machines and ultrasound diagnostic system, we can see that Siemens layout power in the Chinese market This is in full accord with the rapid growth of the Chinese market in its earnings report.
Joint Medical (Shanghai United Film and Changzhou United Film), the number of approvals: 6, came in second.
Among them, there are four Shanghai Liangyu approval documents, including X-ray computed tomography equipment 2 (State registration of 20173301504 and equipment registration 20173301569), positron emission and X-ray computed tomography scanning system 20173331479) and a magnetic resonance imaging system (Guoliao 20173281565).
In addition, UNIKE set up its branch office in Changzhou in January 2016 to operate technology development, transfer and consultation. In 2017, Changzhou Liangyu's X-ray computed tomography equipment obtained two registration approvals (Guozhi injection 20173301562 and Guozizhidan 20173301300).
Philips (including Philips Medical Systems Nederland BV and Philips Medical Systems (Cleveland), Inc.) received 3 approvals and 2 medical magnetic resonance imaging systems (State Instruments into 20173285169 and State Instruments into 20173285269), X-ray Computer 1 CTL (GuoZhi injection into 20173302330) Philips did not have any approval on diagnostic equipment in 2016, and the new approval in 2017 also shows its emphasis on the domestic market.
Sirona Dental Systems GmbH, approved the number of: 3, respectively, for oral surface tomography X-ray machine (State injection into 20173302420), oral and maxillofacial surface tomography X-ray machine into the ( 20173301301) and oral and maxillofacial cone beam computer tomography equipment (Guo-li injection 20173302421).
This enterprise Formerly Siemens Dental, the company has over 130 years of history and is headquartered in Benzheim, Germany and is dedicated to digital dental solutions including CAD / CAM for CEREC and inLab All-ceramic repair system, oral comprehensive treatment units, digital dental X-ray diagnostic system and dental treatment equipment and sterilization equipment.
Shenzhen Anke High-tech Co., Ltd., the number of approvals: 2, are X-ray computed tomography system (Guoliao Note 20173300126 and Guoliao Note 20173300685).
The company is a joint venture between Chinese Academy of Sciences and Analogic, a US-listed Nasdaq hi-tech medical device company established in 1986. The company is mainly engaged in the development, production and operation of high-end medical electronic devices. At present, the products cover medical imaging, medical information, medical electronics and treatment And other four areas.
HOYA Co., Ltd. (TAG Heuer), the approval number: 2, are electronic ultrasound endoscopy (Guo Liu injection 20173222328 and Guo Lu note into 20173222329), is a production from laser devices to contact lenses and other optical products in Japan The company, headquartered in Tokyo.
Fujifilm Co., Ltd. (Fuji Photo Film Co., Ltd.), the number of approvals: 2, are electronic ultrasound endoscopy (state injection into 20173222263 and state equipment into the 20173222265. Fuji comprehensive video, One of the manufacturers and suppliers of document processing products and services.
General Electric Medical Systems (China) Co., Ltd., Approval number: 2, both color Doppler ultrasound diagnostic instruments (Guoluqi 20173231302 and Guolujian 20173231432). General Electric 2016 magnetic resonance imaging system was approved.
Shanghai Siemens, the number of approvals: 2, are X-ray computed tomography equipment, approval for the domestic manufacturers. (Guoluqi 20173301353 and state equipment, registration 20173301355).
Lightlab Imaging Inc. Approved Quantities: 2, Optical Interferometric Tomography System (Guo-li injection 20173222408) and single-use endovascular imaging catheter (Guo-li injection 20173772288).
The company is based on optical interference tomography (OCT) and other intravascular ultrasound product development based international enterprises.
Shenzhen Siemens, approved the number of: 2, magnetic resonance imaging system (Guoluqi 20173281472 and Guoliao Note 20173283120).
Xuzhou Kaixin Electronic Equipment Co., Ltd., approved the number of: 2, Ophthalmology A / B ultrasonic diagnostic apparatus (Guoluqi 20173230925) and ophthalmic A-type ultrasonic measuring instrument (Guoliang 注准 20173233195). The company is committed to ultrasound technology In the field of medical applications and product innovation.
