Medical network - on July 5, June 19, the state administration of drug safety deputy bureau telephoto red, general instrument registration division, supervision, standard tube center, inspection center, head of the centre for review and related personnel, with the Chinese institute of biomedical engineering experts and representatives of research and development enterprise, medical device innovation and development conference held in Beijing union.
As the name implies, this conference focuses on the innovation and policy incentives of the medical device industry, such as reviewing and approving relevant policies. The two main products discussed in the conference are "neuro - control technology" and "in vitro diagnostic techniques".
On June 28, ma, the director of the commission's disciplinary inspection commission, conducted a survey on the CFDA equipment registry and surveillance department. Horse racing, two department to implement all work of the medical equipment examination and approval and supervision, to medical equipment examination and approval and the characteristics of the dominant power is concentrated in the regulatory process, carefully developed preventive measures.
On July 4, the CFDA website posted a list of key medical devices approved by the general administration of China in the first half of 2017.
A series of information shows that CFDA's approval for medical device registration reform will be accelerated in the second half of this year.
Value in the first half of this year has ended, and the second half of the year has just begun, the blue parker equipment to the state and the local food and drug administration approved in the first half of this year's important product, as well as into the innovation and the preferred channel for examination and approval of medical apparatus and instruments product inventory.
The "lucky" obtain the special examination and approval or examination and approval of the green channel priority products, or belong to the innovation of medical equipment, some products fill the blank of domestic initiative, either won the support of major national scientific research projects focus on product, or is a manufacturing enterprise and its previous product quality credit withstand test.
All in all, these products, arguably the first half of 2017, have been approved by state and local food and drug administration, or decided to examine and approve important products listed in the market, which is also worthy of the attention of the industry.
Details of the product list are below:
CFDA approves listed 7 major medical devices
According to the CFDA news, in the first half of this year, administration approved the total seven key medical apparatus and instruments, the common characteristics of the products is innovative products of domestic initiation, or able to break the foreign manufacturers monopoly.
Include:
1. Disposable nailing internal stapling device
Registered applicant: Beijing yihe hengrui medical technology co. LTD
2, intervene in artificial biological heart valves
Registered applicant: suzhou jicheng medical technology co. LTD
3. Percutaneous involvement of artificial heart valve system
Registered applicant: hangzhou qiming medical equipment co. LTD
4. Variable Angle dual-probe single photon emission computed tomography equipment
Registered applicant: Beijing yongxin medical equipment co. LTD
5. Total degradation of the sinus drug stent system
Registered applicant: pu yi (Shanghai) biotechnology co. LTD
6. Cryogenic cryosurgery system and disposable sterile cryoablation needle
Registered applicant: hai jaya (Beijing) medical equipment co. LTD
7. Pulmonary artery flap duct
Registered applicant: Beijing baiyan medical technology co. LTD
Three medical devices enter the CFDA priority approval channel
According to the CFDA, in the first half of this year, the general administration issued a total of 3 priority approval applications for medical devices in the first half of this year, and a total of 3 medical device registration projects were approved for priority approval.
Include:
1. Drug eluting balloon catheter
Applicant: liaoning boundless biotechnology co. LTD
Agree reasons: clinical urgent need, and there are no medical instruments licensed to register with variety products in our country. (can be used for coronary bifurcation lesions)
2. Hollow fiber membrane hemodialysis filter
Applicant: chengdu European medical equipment co., LTD
Agreement: to be included in the state key research and development plan
3. Hemodialysis/filtration device
Applicant: guangzhou jihua medical equipment co. LTD
Agreement: to be included in the state key research and development plan
Guangdong: 26 medical equipment priority approval
In addition, the guangdong provincial drug administration issued a review of the first half of the second category of medical devices in the first half of this year, and a total of 26 types of instruments were given priority approval.
Include:
1. Automatic glycosylated hemoglobin analyzer
Applicant: shenzhen renoir technology industry co., LTD
Agree to reason: one year is evaluated by ShengJu quality credit class A, and this year is not in production during the rectification or involved in processing, no medical instrument quality announcement unqualified medical device manufacturing enterprise.
2. Cardiac fatty acid binding protein (h-fabp) determination kit (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
3. Total c-reactive protein (CRP) determination kit (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
4. D - Dimer (d-dimer) determination of kit (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
5. Cardiac calcium protein I (cTnI) determination of kit (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
6. Calcitonin (PCT) determination of kit (fluorescence immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
7, N terminal brain sodium peptide (nt-probnp) testing kits (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on reasons: same as above
8. Determination of myocardial calcium protein I/creatinine kinase/myoglobin three-in-one test kit (fluorescent immunochromatography)
Applicant: shenzhen renoir technology industrial co. LTD
Agree on the reason: the same
Full digital color doppler ultrasonic diagnosis system
Applicant: shantou ultrasonic instrument research institute limited
Agree on reasons: same as above
10. Full-digital color doppler ultrasound diagnosis system
Applicant: shantou ultrasonic instrument institute co. LTD
Agree on reasons: same as above
11. Full-digital color doppler ultrasound diagnosis system
Applicant: shantou ultrasonic instrument institute co. LTD
Agree on reasons: same as above
12. Chemiluminescence apparatus
Applicant: shenzhen yahui long biotechnology co., LTD
Agree on reasons: same as above
Hand-held neuromuscular stimulator
Applicant: guangzhou long zhijie technology co. LTD
Agree on reasons: same as above
14. Balanced functional assessment and training system
Applicant: guangzhou long zhijie technology co. LTD
Agree on reasons: same as above
Use sterile sterilization kits at once
Applicant: shenzhen cooper technology development co. LTD
Agree on reasons: same as above
16. Disposable non-invasive medical temperature sensor
Applicant: shenzhen cooper technology development co. LTD
Agree on reasons: same as above
The peritoneal dialysis takes over
Applicant: shenzhen cooper technology development co. LTD
Agree on reasons: same as above
Use zebra guides at once
Applicant: shenzhen cooper science and technology development co., LTD
Agree on reasons: same as above
19. Colloidal gold test paper analyzer
Applicant: zhuhai lizhu reagent co. LTD
Agree on reasons: same as above
20. Automatic vaginal disease analyzer
Applicant: zhuhai lizhu reagent co. LTD
Agree on the reason: the same
21. Deglutition dysfunction electrical stimulator
Applicant: guangzhou long zhijie technology co. LTD
Agree on reasons: same as above
22. D-dimer detection kit (magneto immunoassay)
Applicant: dongguan boshi biotechnology co. LTD
Reason for agreeing: unknown
23. D-dimer/hs-crp test kit (magneto immunoassay)
Applicant: dongguan boshi biotechnology co. LTD
Reason for agreeing: unknown
24. Calcitonin (PCT) test kit (magnetic sensitive immunoassay)
Applicant: dongguan boshi biotechnology co. LTD
Reason for agreeing: unknown
25. Cardiac fatty acid binding protein (h-fabp) test kit (magneto immunoassay)
Applicant: dongguan boshi biotechnology co. LTD
Reason for agreeing: unknown
26. Lipoprotein related phospholipase A2 (Lp - PLA2) test kit (magneto immunoassay)
Applicant: dongguan boshi biotechnology co., LTD
Reason for agreeing: unknown
39 innovative medical devices enter the CFDA special approval channel
On the basis of the CFDA news, in the first half of this year, administration released a total of 5) innovation medical instrument special approval to apply for review the results of the public, a total of 39 medical device registration shall be special examination and approval of project formulation.
Include:
Via the catheter aortic valve system
Applicant: peijia medical technology (suzhou) co. LTD
2. Bioabsorption of the coronary arterial rapamycin eluting stent system
Applicant: Shanghai baixin biotechnology co. LTD
3. Interventional magnetic resonance system
Applicant: Shanghai airifeng medical technology co. LTD
4. Low energy pulse ultrasonic therapeutic apparatus
Applicant: Beijing wanli force medical equipment co. LTD
5. SPACO OMX6i medical electron linear accelerator
Applicant: guangdong energy accelerator technology co. LTD
6. Cryogenic cryosurgery system (including disposable sterile cryoablation needle)
Applicant: hai jaya (Beijing) medical equipment co. LTD
7. Skin photomicrograph
Applicant: guangzhou baihe electronic technology co. LTD
8. Peripheral vascular stent system
Applicant: suzhou yinluo medical equipment co. LTD
9. Cryofocus cryoablation system (including cryoablation equipment, cryoablation catheter)
Applicant: kangfo biotechnology (Shanghai) co. LTD
10. Shockwave therapeutic apparatus
Applicant: shenzhen huikang precision instrument co., LTD
11. Left atrial closure system
Applicant: hangzhou nuomao medical technology co. LTD
12. Drug eluting peripheral vascular stent system
Applicant: zhejiang guichuang medical equipment co. LTD
13. Hydrogen and oxygen aerosol
Applicant: Shanghai Hui medical technology co., LTD
14. Human SDC2 gene methylation test kit (fluorescent PCR)
Applicant: guangzhou kangli Ming biotechnology co. LTD
15. Neurosurgical robot navigation and positioning system
Applicant: huake precision (Beijing) medical technology co. LTD
16. GNAS gene mutation detection kit
Applicant: tianjin fine resistance gene biotechnology co. LTD
17. Human EGFR gene mutation detection kit (multiple fluorescent PCR)
Applicant: xiamen edade biological medicine technology co. LTD
A joint test kit for human cancer multigene mutation (reversible terminal termination sequencing)
Applicant: xiamen edade biological medicine technology co. LTD
19. Paclitaxel eluting PTCA balloon dilation catheter
Applicant: zhejiang batai medical technology co. LTD
The abdominal aorta laminated scaffold and delivery system
Applicant: minimally invasive pulse medical technology (Shanghai) co. LTD
21. Renal artery radiofrequency ablation catheter
Applicant: Shanghai micro-electric medical science and technology co., LTD
22. Collagen cartilage regeneration vector
Applicant: Ubiosis Co. Ltd
23. Lung cancer targeted drug gene mutation detection kit (high-throughput sequencing method)
Applicant: nanjing world and medical equipment co. LTD
24. Chip digital polymerase chain reaction (DPCR) analysis system
Applicant: nanjing kovitsi biotechnology co. LTD
25, left heart ear closure
Applicant: Shanghai shape memory alloy materials co., LTD
26. Biochemical immune quantitative analysis system
Applicant: basic egg biotechnology co. LTD
27. Sterile heart ear clip and conveying system
Applicant: Beijing meidi summit medical technology co. LTD
Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 gene mutation testing kits (semiconductor sequencing)
Applicant: tianjin norhe zhiyuan bio-information technology co. LTD
19. Gastric cancer methylation gene detection kit (PCR fluorescence probe method)
Applicant: bocheng (Beijing) technology co., LTD
The neonatal total galactose determination kit (fluorescence analysis)
Applicant: guangzhou fenghua biological engineering co. LTD
31. Product name: low-temperature plasma operating system
Applicant: Beijing nortes technology co. LTD
The measurement system of quantitative blood flow score
Applicant: bog medical imaging technology (Shanghai) co. LTD
Adsorbed blood dialysis system
Applicant: medtronic medical instrument (chengdu) co. LTD
The positron emission tomography and magnetic resonance imaging system
Applicant: Shanghai lianying medical technology co. LTD
35. Bioabsorbable coronary arterial rapamycin eluting stent system
Applicant: Beijing amet medical equipment co. LTD
36. Bioabsorption of the coronary arterial rapamycin eluting stent system
Applicant: shenzhen xinlitai biological medical engineering co. LTD
37. Near-infrared fluorescence imaging system
Applicant: Beijing digital precision medical technology co. LTD
38. Pre-implantation of preimplantation chromosome aneuploid test kit (semiconductor sequencing)
Applicant: orderkang medical technology (suzhou) co. LTD
39. Surgical sealant
Applicant: hangzhou yhui biotechnology co. LTD
Beijing: six innovative medical devices are specially approved
In addition, in the first half of this year, the Beijing municipal pharmaceutical administration issued six innovative medical device products, including six medical devices.
Include:
Portable automatic biochemical analysis system (microfluidic biochemical analyzer/sugar fat four test kits (microfluidic chip)
Applicant: bo o yi and health science and technology (Beijing) co. LTD
2. No shadow imager
Applicant: bo oyi and health science and technology (Beijing) co., LTD
Flexible smart ankle training system
Applicant: Beijing litek technology co. LTD
Near infrared fluorescence imaging system
Applicant: Beijing digital precision medical technology co. LTD
"Test kits for microbiological identification of airborne time mass spectrometry system" and "CYP2C19 and ABCB1 genetic testing kits" (microarray chip - flight time mass spectrometry).
Applicant: Beijing yixin botron biotechnology co. LTD
6. Non-invasive prenatal fetal chromosome aneuploidy analysis software
Applicant: anno yoda gene technology (Beijing) co. LTD
Zhejiang province: 6 medical devices specially approved, 1 innovative medical equipment listed
In the first half of this year, the zhejiang province food and drug administration issued several messages, a total of a medical device products by the province of the second category of innovative medical devices for examination and approval of special application review, special review proposed.
Include:
1. Exoskeleton walker
Applicant: ningbo summit robot co. LTD
Remarks: this product is a domestic initiative.
2, electric e « ” ‚ needle
Applicant: zhejiang sikorborui medical technology co. LTD
3. Heparin binding protein determination kit (immunofluorescence dry method)
Applicant: zhonghan shengtai biotechnology co., LTD
4. Pathological slice tissue imaging system
Applicant: hangzhou fini technology co. LTD
5. Humoral balance monitor
Applicant: zhejiang new blue technology co. LTD
6. Bladder stimulation electrode
Applicant: hangzhou promises medical technology co. LTD
In addition, the zhejiang province food and drug administration in yongchuan recently examined and approved the hangzhou science and technology co., LTD. Product innovation "brain electrical impedance tomography imaging" registered, the product is also the first in zhejiang province approved the second category of innovative medical devices.
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