Medical network on January 4 - on January 3, 2017, total bureau of national drug safety announcement, a few days ago, the bureau for examination and approval again a high-end medical equipment products to fill the domestic blank.
According to the blue parker instrument, this also is in 2016, the state administration of drug safety shall be a separate announcement, fill the blank of the domestic medical equipment/notarized break the monopoly of 9 cases of products to be imported.
Compared with the previous, after entering 2016, the drug safety administration of examination and approval of innovative medical devices products significantly speeding up, the newly approved domestic blockbuster innovation medical instrument quantity will increase dramatically.
Since 2013, the administration of special announcement, the approved domestic blockbuster YiXie product list:
The following for the administration of drug safety approved in 2016, domestic blockbuster YiXie product details:
Pulmonary valve pipe products approved by the public
January 3, 2017
Recently, the state administration of drug safety after examination and approval of kernel medical technology co., LTD, Beijing registered pulmonary artery with disc pipes.
The product by the heart heart side pipe near and far end of pipe, into the end flow to end the parts inside the same (8-17 mm). Close to the heart with a native client pipeline in bovine jugular vein group in the 3 leaf valve, valve on the far side pipe using bovine pericardial tissue heart, through the cell, remove immunogenicity and series of tissue calcification resistance modification, then through the bionic structure design and sewing process. The product by the artificial biological pulmonary valve and without stents creatures of great vessels, used for cardiac surgery implants, surgical reconstruction of right ventricular outflow tract or replace the previously implanted loss pipeline, treatment of right ventricular outflow tract malformation or pathological changes of the patients.
Approval of the product for the first time, filled the domestic medical equipment in the field of high-end artificial biological heart valve blank, for the majority of children with complex congenital heart disease.
Orthopaedic surgery navigation and positioning system is approved
Published on November 24, 2016
On November 14, 2016, the state administration of drug safety after examination and approval of the days of air medical technology co., LTD., Beijing orthopaedic surgery navigation and positioning system (model: TiRobot) medical device registration.
The device by the host, mechanical arm, surgery planning and control software, optical tracking system, master station and navigation and positioning kit, used in spine surgery and trauma orthopaedics open or percutaneous surgery assisted by mechanical arm to complete surgical instruments or implant positioning.
The orthopaedic surgery navigation system consists of six degrees of freedom mechanical arm and compatible with 2 d and 3 d medical image such as patent technology, each performance index has reached the international level, similar product is suitable for using orthopaedic trauma hollow screw fixation and spinal screw fixation of the patients, can effectively ensure the accuracy of screw placement, shorten the operation time, reduce the X-ray radiation damage, reduce the injury patients.
In front of the domestic market, the products are mainly for the United States and Germany imported products.
Innovative products intraocular lens
Published on November 24, 2016
On November 21, 2016, the state administration of drug safety after examination and approval of aibo noble (Beijing) medical technology co., LTD. Registration of intraocular lens.
This product is a type posterior chamber intraocular lens, folding, loop form for L, main and supporting parts are made from a material such as ethyl acrylate polymer, add uv absorber and blue light absorber. High surface after the product has "convex", "high order aspheric", "complex surface form independent separation" and "edge thickness" and "hydrophobic with heparin modified acrylate material" wait for a characteristic, is the first in the domestic intraocular lens, for domestic equipment in the field of high-end intraocular lens a big step forward.
Suitable for adults with no crystal eyes and vision correction of primary corneal astigmatism after remove cataracts, aimed at improving eyesight, reduce the residual powder luminosity and reduce dependence on far sight glasses.
Domestic innovative PET/CT were allowed to register
Published on October 20, 2016
Recently, the state administration of drug safety after examination and approval the MingFeng medical systems co., LTD., production of "positron emission and X-ray computed tomography (ct) imaging device". The product by the scanning plane (including PET frame, PET detector, data acquisition system and computed tomography (CT) frame, X-ray tube assembly, high voltage generator, CT detector, limited beam splitter), diagnosis bed, power cabinets, computer image processing system and a control box.
This product combines X-ray computed tomography (CT) and positron emission computed tomography (PET) system, provide the physiological and anatomic information of registration and fusion. The product gamma photon localization precision, digital signal processing and sampling method is advanced, the generated image at the same time, including the functions of human organs and tissues or anatomical information, information can be used for tumor, brain diseases, and cardiovascular disease diagnosis, treatment and curative effect evaluation and so on.
The product approved, marking China's large-scale high-end medical imaging equipment development and production levels on a new step, break the present situation of the imported similar products mainly.
Three domestic to detect mycobacterium tuberculosis drug resistance in vitro diagnostic reagents for the first time
September 7, 2016
On September 2, 2016, the state administration of drug safety after examination and approval of the xiamen to good biological technology co., LTD production of "mycobacterium tuberculosis fluoroquinolone drugs resistant mutation detection kit (fluorescence PCR melting curve method)" and "mycobacterium tuberculosis streptomycin resistance mutation detection kit (fluorescence PCR melting curve method)" and "mycobacterium tuberculosis ethambutol resistant mutation detection kit (fluorescence PCR melting curve method)". Three products are made by amplification of reagents, reference reagent and extraction reagent.
The above three in vitro diagnostic reagents is domestic similar products approved for the first time, were used to detect mycobacterium tuberculosis of fluoroquinolone drugs resistance, resistance or ethambutol streptomycin drugs drug resistance, can be used for clinical auxiliary diagnosis of tuberculosis. The products listed, is conducive to timely diagnosis and treatment of mdr-tb patients, so as to better control and treatment of tuberculosis.
Drug-eluting peripheral catheter balloon expansion is approved
Published on May 30, 2016
Recently, the state administration of drug safety approval of Beijing first rita medical technology co., LTD. Production of "drug-eluting peripheral catheter balloon expansion".
The product type for whole exchange catheter balloon expansion, with paclitaxel drug-coated balloon surface, used in femoral and popliteal artery angioplasty (PTA) in the bellows. In the process of a balloon catheter, drug taxol release of coating to target lesion blood vessel walls, the inhibition of neointimal hyperplasia. Clinical test results show that the effectiveness is better than that of uncoated catheter balloon expansion.
This product is the first domestic for peripheral artery catheter drug-eluting balloon expansion, provides a new treatment option for clinical doctors and patients.
Implantable vagus nerve stimulation pulse generator sets and implantable vagus nerve stimulation electrode wires suite is approved
May 23, 2016
On May 16, 2016, the state administration of drug safety after examination and approval of the Beijing product chi medical equipment co., LTD., production of "implantable vagus nerve stimulation pulse generator suite" and "implantable vagus nerve stimulation electrode wire suite" two products.
"Implantable vagus nerve stimulation pulse generator kit" by the pulse generator, test the resistance, torque screwdriver, and control the magnet. "Implantable vagus nerve stimulation electrode wire suite" by the electrode, making tunnel tools (including piercing tools and casing) and clamp.
The above two products, patients with intractable epilepsy for drugs cannot effectively control can have the effect of control seizures, vagus nerve stimulation is the first domestic product for the treatment of epilepsy.
