Medical device registrant system, it is very fierce

Medical Network August 13th A very similar policy, in the pharmaceutical industry in 10 provinces pilot, the time is so long, but the response is flat.

However, when it was put into the field of medical devices, it was only piloted in one city, but it was very enthusiastic in a short time.

This is the 'registrant system' that the entire medical circle is concerned about. Why is this concern, mainly the common research, production, and sales models in the past, and it is very likely that it will change due to the implementation of this system.

The Shanghai Free Trade Zone is the first pilot of this system. But soon, the pilot has expanded to Shanghai, China.

A few days ago, the Shanghai Food and Drug Administration met to inform the 'results' of the pilot:

This system was only started in the self-retained area in December last year. It was only expanded to the whole Shanghai pilot in July this year. From the initial pilot to today, it is only eight or nine months, but there are already 10 companies. The products entered the priority registration detection channel, and 9 of the 4 companies passed the registration test; 6 products of 3 companies were approved according to the “Pilot Program”; 57 enterprises participated in the pilot intention.

The three pilot cases that have been approved are for the group commissioned, non-associated entities to cross-regional entrustment, and the listed products have expanded the production site through this pilot, covering the second category of medical devices and in vitro diagnostic reagents.

with drug In comparison, in the field of medicine, a few companies in the 10 provinces are also trying the registrant system, but most of them are also commissioned within the group, and there are almost no inter-submissions.

The medical device 'acquisition certificate' is actually easier than medicine, especially the second-class medical equipment, the provincial bureau can approve. Compared with the 'acquisition certificate', building a factory may be a more difficult matter, and it is considered a 'heavy asset'.

After the implementation of the registrant system, there is no production condition to 'take the certificate'. This is a major loosening of the developers, so that many companies with R&D and marketing capabilities are ready to go, and they can only kick off the production companies directly and develop products directly. And do marketing, the production of this piece is entrusted to a third party.

In this way, R&D is in its own hands, the brand is in its own hands, and marketing is in its own hands, becoming a 'factory' and dealer without a factory. proxy The era of business destiny is in the hands of production companies, and it has never returned.

This, we must redefine the role of the production enterprise, the agent. From the Shanghai pilot data, the industry's attention and very high. This change will eventually affect a large number of medical personnel, whether it is manufacturers, or agent distribution Business, and research and development institutions.

A Shanghai, for a short period of time, is so hot. After expanding to 31 provinces and cities across the country, what trend will this trend be converging?

In fact, the pilot of this system has already broken through the scope of Shanghai.

In May this year, the State Council issued the “Deepening of China (Guangdong), (Tianjin), (Fujian) Free Trade Pilot Zone Reform and Opening Program.” For the Guangdong and Tianjin Free Trade Zones, the State Council separately proposed:

Allow Guangdong Free Trade Zone medical instruments Registered applicant entrusted medical equipment production in Guangdong Province enterprise product;

Applicants for medical device registration in the Tianjin Pilot Free Trade Zone are allowed to commission Tianjin medical device manufacturers to produce products.

That is to say, in addition to the Shanghai pilot, the medical device registrant system has been extended to Tianjin and Guangdong. Tianjin and Guangdong do not mention the word 'pilot', and the one is 'allowed'.

It has been split and spread. It is really thirty years of Hedong, thirty years of Hexi, capable medical research and development institutions and agent dealers, must be squid jumping dragon gate, serf turned over to be the master, holding the two key links of technology research and development and marketing, Let some manufacturers become 'Foxconn'.

Medical device manufacturers that lack research and development capabilities and marketing capabilities will face major challenges. If the orders for commissioned production are not grabbed, the possibility of being eliminated is high.

R & D and marketing have to 'call', and in this upcoming big and medium, where are you going, it is time to seriously think.