Yesterday (July 5), the Shanghai Food and Drug Administration issued the "Notice on Extending the Pilot Program for the Reform of the Medical Device Registrant System in the City to the Whole Citywide Implementation" (hereinafter referred to as the Announcement). The reform of the trade pilot zone and the reform of the Shanghai Municipality, the various reform pilot tasks are fully implemented within the scope of the Pudong New Area, or the requirements for the promotion of trials in Shanghai. On the basis of the previous pilots, it was decided to The pilot was extended to the whole city, and the trial of the reform of the medical device registrant system was extended to the whole city, allowing medical device registration applicants in Shanghai to entrust Shanghai medical device manufacturers to produce products. The so-called "medical device registrant system" means that a qualified medical device registration applicant can apply for a medical device registration certificate separately, and then entrust it to a qualified and productive production enterprise to realize the registration and production license of the medical device product. “Unbundlingâ€, the medical device registrant system is the system of listing license holders under the current medical device regulations. In the past, China's medical devices implemented a “bundling†model of product registration and production licenses, which affected the responsibility and enthusiasm for innovative R&D and continuous improvement of product quality, and limited the rational allocation of innovation factors, and also did not conform to internationally accepted rules. When the system comes out, enterprises no longer have to bear the operational pressures of production equipment, personnel, venues and other assets. They can invest more resources and energy into product R&D and innovation, which is conducive to accelerating the launch and landing of innovative products. From the perspective of the industry, this is also conducive to the structural adjustment of enterprises, breaking through the constraints of land resources and environmental resources, and promoting the division of labor and cooperation between the upstream and downstream of the medical device industry chain. In December 2017, the Shanghai Food and Drug Administration issued the “Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone†(hereinafter referred to as the pilot program), and the response of the industry enterprises was very enthusiastic. On February 27, 2018, the single-channel ECG recorder of Shanghai Yuanxin Medical Technology Co., Ltd., a subsidiary of MicroPort Medical, was approved and entrusted Shanghai Mini-Chuang Electrophysiology Medical Technology Co., Ltd. to become the first and second listed company. Class medical equipment products, which marked the official launch of the pilot reform of the medical device registrant system in the Shanghai Free Trade Zone. According to the report of Wenhui Daily, at present, six products of three enterprises in Shanghai have been approved according to the “Pilot Programâ€. Nine products of the three companies have entered the priority registration inspection channel, and seven of the two companies have passed the registration test, 57 The enterprises have participated in the pilot intent, and the three pilot cases that have been approved are for the entrusted group within the group, the inter-regional entrustment of non-associated entities, and the expansion of production sites by the pilot products through this pilot, covering the second category of medical devices and in vitro diagnostic reagents. . However, the Shanghai Food and Drug Administration found in the pilot that due to the limited scope of the pilot, it is difficult to give full play to the advantages of resource allocation in the region. Many enterprises with pilot intentions can only participate in the pilot through the establishment of a separate company in the free trade zone. Many companies are eager to expand the scope of the pilot to the city. Lin Feng, Director of the Equipment Registrar of the Shanghai Food and Drug Administration, said that the scope of the pilot project will be extended to the whole city, which will further solve the problem of regional restrictions on enterprises participating in the pilot, so that the enthusiasm of enterprises will be further enhanced, and the pilot types will be enriched. It will further promote the differentiated division of labor and cooperation of various medical device enterprises in this city, and form the aggregation effect of each district park, and the effect of resource optimization and allocation will become more and more apparent. It is also known that the Shanghai Food and Drug Administration is also actively promoting the third-class products to be included in the pilot service and the docking with the National Bureau of the Laboratory, in order to achieve full coverage of the pilot product category at an early date.
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