Medical network - on April 24, April 21, the CFDA release information of the public, a total of 1 medical devices will receive special examination and approval, it will enter the eight priority for examination and approval. 

 

A medical devices to be put into priority for examination and approval 

 

On April 21, the CFDA medical instrument technical evaluation center "audit result of the public medical device is preferred for examination and approval of application no. 3 (2017)", if not unexpected, and a domestic medical equipment is a national priority for examination and approval. 

 

According to public information, the product name, called "drug-eluting balloon catheter, applicant is liaoning art nebula-rich complex biological technology co., LTD. Application center thought, the product is "urgent clinical needs, and their varieties in our country, there is no registration of medical apparatus and instruments; can be used for coronary bifurcation lesions". 

 

The blue equipment query CFDA related data, parker similar imported products not retrieved, domestic name didn't retrieved the same product. 

 

But there's a name similar to that of domestic equipment in approved on May 25 last year. This product is made by Beijing medical technology co., LTD registered first, its name is called "drug-eluting peripheral catheter balloon expansion", the CFDA requirements after the registration is approved, the product and complete the following work: after the products listed in 12 months target vascular patency rate as the main the registration at the end of observation research, followed up for at least 1 year, submit statistical analysis reports in continuation of the time of registration. 

 

According to understand, liaoning art nebula-rich complex biological, founded in 2004, is entirely founded by university of science and technology personnel of enterprises, mainly engaged in cardiovascular stents and other three kinds of interventional medical equipment research and development, production and sales. 

 

It is reported, this is since this year the CFDA preferred examination and approval of 3 medical equipment products. In the preceding two paragraphs products are included in the national key research and development, respectively is chengdu European competitions medical instrument co., LTD. Application of the hollow fiber membrane hemodialysis filtration apparatus ", guangzhou medical devices co., LTD. And China to apply for "hemodialysis/filtration device". 

 

Eight innovative medical devices to be put into special examination and approval 

 

On the same day, the center also released the innovation medical instrument special approval to apply for review the results of the public no. 3 (2017), and there were eight innovative medical devices to be put into special channels for examination and approval, if no objection, will take effect. The eight product and the applicant is as follows: