On July 7,the State Council issued the "Notice on Doing a Good Job in the Duplication and Promotion of the Sixth Batch of Reform Pilot Experiences in the Pilot Free Trade Zone." The "Notice" pointed out that the locality and relevant departments of the pilot free trade zone, combined with the functional positioning and characteristics of the respective pilot free trade zones, made every effort to promote the practice of system innovation, and formed the sixth batch of reform pilot experiences in the pilot free trade zones, which will be replicated nationwide. Promotion.
      Among them, Article 36 refers to the entrusted production mode of medical device registrants. In addition to self-produced products, medical device registrants may entrust enterprises with corresponding production conditions to produce products. The unit responsible for the production model entrusted by the medical device registrant is the State Drug Administration, and the scope of promotion is nationwide. This will undoubtedly bring benefits to the medical device industry.
      The medical device registrant system is the marketing authorization holder system in the field of medical devices. Under this system, qualified medical device registration applicants can individually apply for a medical device registration certificate. Then it is entrusted to enterprises with qualifications and production capacity to produce, so as to realize the "unbinding" of medical device product registration and production license.
      Previously, China’s medical device industry implemented a “bundled” model of product registration and production license. Registrants must set up their own factories to produce products. If they want to commission production, both parties must have both the medical device registration certificate and production license. This not only increases the number of enterprises Costs extend the time to market for products, and are also not conducive to corporate innovation. Especially for small and micro enterprises with R&D capabilities, on the one hand, production control capabilities cannot be formed overnight, on the other hand, the investment in medical device production is huge and difficult to afford. Therefore, the "medical device registrant system" is also regarded as a disruptive reform of the industry.
      The launch of the medical device MAH can effectively solve the dilemmas of limited funds, compliance and lack of production personnel faced by start-ups in the early stage, allowing innovative R&D companies to focus on product R&D, opening production to professional service companies, and strengthening innovation Colleagues reduce business costs.