Under the background of the state's strong support for pharmaceutical innovation, China's medical device industry has also entered a new stage
of development.
According to a research report, since 2013, the market scale of China's medical device industry has been expanding, and it is expected that by 2022, the scale of China's medical device market will reach 1,252.
9 billion yuan, and in 2025, it will reach 1,841.
4 billion yuan
.
At present, under the continuous expansion of the market, medical device companies are also continuously improving
the quality, innovation and technical content of products.
Affected by this, more new results
have emerged.
It is reported that a large number of enterprises have recently obtained medical device registration certificates for their products
.
Lepu Medical Microcatheter obtained the Class III medical device registration certificate
On November 30, Lepu Medical announced that the disposable pressure microcatheter independently developed by the company has recently obtained the registration approval of the State Medical Products Administration and obtained the registration certificate
of Class III medical devices.
This product is expected to measure the pressure of coronary artery lesions in adult patients during coronary angiography and/or interventional procedures, and is suitable for primary lesions with a visual measurement of 40% to 80% stenosis and a diameter of ≥ 2.
5 mm in the reference vessel of the stenosis segment by coronary angiography, and is intended for use by qualified and experienced medical technicians in medical institutions
.
Approval for the establishment of ultrasound diagnostic equipment for medical endoscopy
On November 30, EU-10, the ultrasound diagnostic equipment for endoscopy of the company, which opened a medical announcement, has been approved by the National Medical Products Administration and recently obtained a medical device registration certificate
.
This product is used in medical institutions for endoluminal ultrasound imaging of the digestive tract (esophagus, stomach, duodenum, rectum, colon) and bronchi.
According to the announcement, EU-10 adopts advanced broadband ultrasonic imaging technology and all-digital transmission control technology, which further improves image resolution and penetration depth, better image quality, and enhances the anti-interference ability in the signal transmission process, with the characteristics
of small design and light weight, independent touch operation.
It is worth mentioning that EU-10 also covers endoscopic ultrasound diagnostic equipment in the digestive and respiratory fields, and can be combined with a variety of endoscopic ultrasound probes in the medical digestive and respiratory fields to meet the clinical application
of multiple departments.
Two kits of Aferon have obtained medical device registration certificates
On November 29, Aviron announced that Hunan Zhuorun Biotechnology Co.
, Ltd.
, a subsidiary of its holding subsidiary, recently received two medical device registration certificates issued by the Hunan Provincial Food and Drug Administration, namely fibrin (original) degradation product determination kit (chemiluminescence method) and high-sensitivity troponin I determination kit (chemiluminescence method).
Among them, fibrin (proto) degradation product determination kit is widely used in the diagnosis and treatment of coagulation hemostasis and thrombotic diseases; It is also used for the monitoring
of thrombotic diseases, bleeding-prone diseases, diseases with significantly increased fibrinolytic activity, and thrombolytic therapy.
The high-sensitivity troponin I assay kit can achieve high sensitivity, high accuracy and high specificity detection of troponin I, which is helpful for detecting micro-careful muscle injury that is easy to be missed in the past, early diagnosis of acute myocardial infarction, more reasonable screening of high-risk patients with cardiovascular disease, and optimizing clinical treatment decisions and prognosis assessment
.
MeCan Bio's "Automatic Chemiluminescence Immunoassay Analyzer" obtained the medical device registration certificate
On November 29, MeCan Biologics announced that Ningbo Meikang Shengde Biotechnology Co.
, Ltd.
("Sidley Biotechnology"), a wholly-owned subsidiary of the Company, recently obtained the "Medical Device Registration Certificate" issued by the Zhejiang Provincial Drug Administration, which is: "Automatic Chemiluminescence Immunoassay Analyzer"
.
The product uses acridine-based direct chemiluminescence in conjunction with supporting detection reagents for the qualitative or quantitative detection
of analytes in serum, plasma, whole blood and urine samples derived from humans.
3 reagents and new products in the new industry obtained medical device registration certificates
On November 29, the new industry announced that the company recently received three "Medical Device Registration Certificates"
issued by the Guangdong Provincial Drug Administration.
The product names are "Pepsinogen II Assay Kit (Chemiluminescence Immunoassay)", "Glycocheric Acid Assay Kit (Chemiluminescence Immunoassay)", and "Microalbumin Assay Kit (Chemiluminescence Immunoassay)"
.
It is understood that the acquisition of the medical device registration certificate of the above reagent new products will enrich the "gastric function", "liver function" and "kidney function" project categories in the company's chemiluminescence detection products, which will have a positive impact on the company's development, but will not have a significant impact
on the recent production and operation and performance.
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