Heavyweight reform landed, minimally invasive medical became the first big winner!
Pharmaceutical Network February 28 hearing much-anticipated medical device registrant system reform of the first floor product.
February 8, Shanghai Telecentric Medical Technology Co., Ltd. ("telecentric medical") single-channel ECG recorder by the Shanghai Food and Drug Administration issued the second category of medical device product registration certificate, becoming the first in accordance with " China (Shanghai) Pilot Free Trade Area within the registration system of medical device pilot program "approved the listing of medical devices.
This is also the first product in China to enjoy the new policy of the medical device registrant system.
Shanghai Food and Drug Administration for the product can be described as the green light all the way: January 3 to receive product registration applications, February 8 issued a medical device registration card, February 12 release of medical device manufacturing license review and approval of the work a total of It takes 23 working days (excluding telepathy correction data 5 working days not included) It is said that the legal working time is shortened more than 80%.
As we all know, the state should promote the reform of the registrant system in the medical device industry. Shanghai Free Trade Zone is the first pilot area.
The system of medical device registrants is also to release registration and production licenses for medical device products. Medical enterprises, R & D institutions and scientific researchers can apply for medical device registration certificates separately and then entrust them to qualified and production-oriented enterprises .
This is a move to reduce pressure on both sides of R & D and manufacturing.
R & D companies only need to focus on R & D, without having to invest huge sums of money, invest time and effort to get to, set up factories, access to production licenses; and have to get the production license of the enterprise can also be commissioned by way of production, rapid manufacturing A new product, and to market it.
As a result, this system has been put under the expectation of breaking down the hegemony of state-owned enterprises, promoting innovative research and development of medical device products, promoting specialized division of labor and large-scale production, etc. However, this road still seems to take some time to realize.
Telecentric Medical has been taken to single-channel ECG recorder commissioned by the Shanghai Micro-invasive Electrophysiology Medical Technology Co., Ltd. (referred to as 'minimally invasive electrophysiology'), which has been awarded the medical device manufacturing license.
It is worth noting that telecentric medicine is also a wholly owned subsidiary of minimally invasive electrophysiology.
In 2016 November, Minimally invasive electrophysiological decision was made to invest RMB 5 million to establish telecentric medicine, and the same month, the Shanghai FTZ Bureau issued "Business License" to Telecentric Medical.
The purpose of minimally invasive electrophysiology The establishment of telecentric medicine aims to develop an electrocardiogram patch service primarily for the diagnosis of cardiac arrhythmias. The target market for telecentric medicine is the telemedicine telemedicine market in mobile medicine.
The latest single-channel ECG to get the registration card can also be said to be Telecentric's first business product.
As for the minimally invasive electrophysiology, was established in 2010, listed on the new board last year, its main business heart Electrophysiology interventional equipment research and development, production and sales.
Minimally invasive electrophysiology was originally established as a wholly-owned subsidiary of Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd. ("Minimally Invasive Instruments") in 2015. In 2015, Minimally Invasive Instruments reduced the 100% equity of the Company to RMB 45 million Minimally invasive (Shanghai) Medical Science Investment Co., Ltd. ("Wechoice Investment"
Subsequently, minimally invasive electrophysiology and after 2 replenishment, from wholly foreign-owned enterprises into Sino-foreign joint ventures. The company equity structure is as follows:
H-share listed company Micro-invasive Medical Science Co., Ltd. (referred to as 'minimally invasive medical') is the parent company of the minimally invasive electrophysiological holding parent company and the actual controller of minimally invasive electrophysiology.
Get registration card telecentric medicine and engaged in the production of minimally invasive electrophysiology are in fact a minimally invasive medical.
Minimally invasive success eats the first 'crab' and becomes medical instruments Registrar system reform winner.Company internal resources to large integration, catch the priority approval of the fast batch trains, saving investment funds, but also in time for many competitors at home and abroad to push the product to the market.
The success of minimally invasive, means the same as minimally invasive large enterprise Group, its existing R & D-oriented enterprises, there are production-oriented enterprises, but also can be as minimally invasive, enjoy the medical device registrant system benefits.
However, at the same time, it is a minimally invasive enterprise that is a victory for large enterprise groups. However, it can not simply say that it is the victory of the entire medical device industry.
The medical device registrant system should benefit more medical device enterprises and medical practitioners in a broader scope, and also need other cooperation and division of labor to develop new modes of production.
The medical device industry should open up the chains, encourage innovation, encourage division of labor, require the integration of internal resources of large enterprises, and also require the alliance of powerful enterprises across different industries. Enterprises, institutions and individuals that need no background should also be involved in sharing the fruits of reform and victory .
Earlier preliminary statistics show that in the Shanghai Free Trade Zone already had more than 20 varieties of medical devices plan to declare the reform pilot products.
How to divide the work? Who can eat crab? What kind of progress can be achieved in this innovation?
