The reform of the medical device registrant system has accelerated and accelerated much faster than expected. Thanks to this reform, the existing so-called domestic and imported medical device competition pattern in the industry has also been changed, and a large number of imported medical devices will be Direct localization, and faster approval for listing, and reduce production costs, so that sales can be reduced.
The new path of localization of foreign-invested enterprises will be opened, and can the import of 'domestic alternative imports' be the same?
On July 5, the Shanghai Food and Drug Administration issued an announcement to extend the pilot reform of the medical device registrant system to the city, allowing the applicants for medical device registration in Shanghai to entrust Shanghai medical device manufacturers to produce products.
The Shanghai Food and Drug Administration also said that the bureau is actively promoting reforms, achieving full coverage of the pilot product categories at an early date, and expecting that the medical device registrant system will be applicable in Jiangsu, Zhejiang and Shanghai, breaking geographical limitations and promoting it to the country in a timely manner.
Shanghai has only begun to pilot the medical device registrant system in the Pudong Free Trade Zone since the end of last year. After only half a year, the reform pilot has been extended to the citywide. Not long ago, the State Council approved Tianjin, Guangdong Free Trade Zone pilot medical device registration. People system.
The reform of the medical device registrant system is beyond the imagination. Behind this is the booming aspirations of the industry.
The Shanghai Food and Drug Administration had previously only piloted the Pudong Free Trade Zone. Up to now, six products of three companies have been approved. Nine products of the three companies have entered the priority registration test channel, and 57 companies have participated in the pilot intention. Some companies are interested in registering a research and development center in Shanghai.
The medical device registrant system directly attacks and solves the long-term pain points of the industry. The benefits are multifaceted.
Large enterprise groups are able to optimize and integrate internal resources, reduce duplication of investment and reduce waste;
Innovative medical device companies can focus on R&D, registration, and complete outsourcing of production.
Medical institutions, research institutes and doctors, etc., can also participate, release research and development enthusiasm, and share the fruits of product listing;
R & D, manufacturers with weak brand capabilities can also transform this, focusing on commissioned production, becoming Foxconn in the medical device industry.
Similarly, even greater benefits will be given to foreign medical device companies and imported products.
Medtronic commissioned Jabil Technology to manufacture the surgical power system and became the second pilot approved product for the reform of the medical device registrant system in Shanghai. Further disclosures show that Medtronic’s benefit in this pilot reform is simply too too much.
Jabil Technology is working on a ENT surgical instrument for Medtronic. The previous model adopted by this product was: The product was dismantled into pieces for export to Singapore, reassembled, and sold back to China by import.
Since the medical device registrant system unbinds the registration and production links, the product does not need to travel far across the ocean, but directly changed to domestic registration.
As a result, it is reported that not only the product production chain has been shortened, the production logistics cost has been reduced, and the time to market for the product has also been greatly advanced. In the past, the import registration was one year from the application to the certificate; A month or so.
The medical device registrant system opened a new model for the local conversion of imported products (localization of imported products) for Medtronic, and this model can be implemented by other foreign-invested enterprises in Shanghai.
Under the medical device registrant system, foreign-owned machinery enterprises no longer need to relocate their products to the oceans, and do not need to invest heavily in self-built factories in China, or they need to adopt a curve model that cooperates with domestic machinery enterprises (such as Medtronic and Weigao, On the contrary, the production process has been shortened, the cost has been reduced, the time to market has been greatly advanced, and the price of the products after the listing has also been reduced. Moreover, the products listed in China will be 'domestic' products. Instead of the 'import' product appearance.
This reform, once a large number of foreign-funded machinery enterprises have participated in it, it is conceivable that the localized production of imported medical equipment will be greatly accelerated.
This is a very likely event. Compared with domestic local machinery enterprises, the research and development capabilities of foreign machinery companies are generally stronger, and they are more focused on R&D. They are more inclined to get used to outsourcing production links. The medical device registrant system provides a better optimization path.
The change in the appearance of a large number of imported medical devices has directly changed to domestically produced in China. Because of the lower cost, the selling price has also been reduced. Is the so-called distinction between domestic and imported important? 'Domestic alternative imports', 'domestic priority procurement 'Whether the policy, can you benefit from the local national machinery enterprise?
The situation in the medical device industry is in the forefront. Purchasing globalization, global production, global sales, investment globalization... weakening of domestic and import, whether it is local or foreign machinery, important Only in: Product innovation, quality, price!
