Take Guangzhou, Shenzhen and Zhuhai as pilots! “Unbundling” medical device product registration and

  The Southern Network News reporter learned from the Provincial Food and Drug Administration that on August 16, the State Drug Administration approved the "Guangdong Province Medical Device Registrar Pilot Work Program" (hereinafter referred to as the "Program"), marking the beginning of Guangdong The provincial “medical device registrant system” was officially implemented.

  The "Program" proposes that in the future, medical device registration applicants in the three pilot areas of Guangzhou, Shenzhen and Zhuhai can entrust Guangdong medical device manufacturers to produce products.Medical device R&D institutions and researchers are allowed to apply for medical device marketing approval, and breakthroughs have been made in exploring the management model of “unbundling” separation of medical device product registration and production license.

  “Bundling” registration management is not conducive to R&D innovation

  The medical device registrant system means that the qualified medical device registration applicant can apply for the medical device registration certificate separately, and then entrust it to the production enterprise with qualification and production capacity.Thereby achieving the "unbundling" of medical device product registration and production license. The medical device registrant system is the system of listing license holders under the current medical device regulations.

  In the past ten years, China's medical device innovation and entrepreneurship has been highly active, new products and new formats have emerged. The average annual growth rate of the medical device market from 2001 to 2016 is 22.37%, far exceeding the global medical device industry by 7%-8%. Speed up.

  Among them, Guangdong's medical device industry has a good foundation and medical device innovation is active.According to statistics from 2017, Guangdong enterprises have received 155 medical devices approved by the State Food and Drug Administration, accounting for about one-fifth of the national total number.The number of products entering the General Administration's special examination and approval procedures accounted for one-fifth of the total number of the country; the number of products entering the General Administration's priority approval procedures accounted for one-third of the national total number; the province's output value was about 130 billion yuan, accounting for nearly one-third of the national total number; There were 51 innovations in the three categories, a year-on-year increase of 50%.In the new round of competition in the medical device industry, Guangdong faces a more complex market environment and more arduous transformation challenges. It needs to rely on global resource allocation elements and rely on institutional innovation to promote development.

  On June 1, 2014, the newly revised Regulations on the Supervision and Administration of Medical Devices and the implementation of supporting regulations were promulgated.Although the requirement to apply for registration by the enterprise that obtained the production license has been changed, the product registration is first processed and the production license is processed. However, the law still requires that the applicant must be an enterprise, and the manufacturer must set up the factory to produce the product. Entrusted production, essentially “bundling” product registration and production licenses.

  With the gradual improvement of China's market economic system, the continuous development of the pharmaceutical industry's innovative research and development capabilities, and the growing demand for safe, effective and accessible drugs by the people, the drawbacks of this "bundling" registration management have become increasingly prominent.It has affected the responsibility and enthusiasm of innovative R&D and continuous improvement of product quality, and limited the rational allocation of innovation factors, which has become one of the factors restricting the further development of China's medical device industry.

  In August 2015, the State Council issued the "Opinions on Reforming the Examination and Approval System for Pharmaceutical Medical Devices" (Guo Fa [2015] No. 44) unveiled the curtain of deepening the reform of China's drug regulatory system. The system of holders of drugs and medical devices listed on the market is one of the important contents.

  On October 8, 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices", which also clarified the direction of reform and proposed to strengthen the life cycle management of pharmaceutical medical devices. Promote the full implementation of the listing permit holder system.We will promptly summarize the pilot experience of the drug listing permit holder system, promote the revision of the drug management law, and strive to open it nationwide as soon as possible.

  Product “Incubation” period The applicant for the registration of the medical device in the free trade zone can entrust production

  The reform measures related to the “medical device registrant system” in this “Program” mainly include five items. First, applicants for medical device registration in the China (Guangdong) Pilot Free Trade Zone and medical device registration applicants in Guangzhou, Shenzhen, and Zhuhai can be entrusted to produce medical samples from Guangdong medical device manufacturers.This means that when the product is still in the “incubation” phase, the applicant for medical device registration in the FTZ is allowed to commission production, regardless of whether the sample enters the special approval process for innovative medical devices.

  At the same time, registrants are allowed to produce or entrust other companies to produce medical devices. After obtaining the registration certificate, if the registrant has the corresponding production capacity, it can produce it after handling the medical device production license;If the registrant does not have the corresponding production capacity, he may entrust other enterprises to produce and handle the relevant procedures for entrusted production. If the trustee does not have the corresponding production qualification, he may submit the registrant's medical device registration certificate for production license.

  In the sales process, the "Program" proposes that the registrant can sell the medical device by himself, without having to apply for a medical device business license or filing, or entrust a medical device operating enterprise with the corresponding conditions to sell the medical device.When entrusting the sale of medical devices, the registrant shall be responsible for the quality of the medical devices entrusted for sale, sign a commission agreement with the entrusted business enterprise, clarify the rights, obligations and responsibilities of both parties, and strengthen the management of the entrusted business operations to ensure that it is sold in accordance with legal requirements.

  For existing medical device manufacturers that already hold registration certificates, registration and production “peeling” can be achieved. The "Program" proposes that medical device manufacturers that have obtained medical device registration certificates in the province can refer to the relevant provisions of the "Program".

In addition, the group company is encouraged to become a registrant. The medical device manufacturing enterprise group company can concentrate the medical device registration certificates of each holding subsidiary to the group company.The group company integrates the products according to the production and processing capabilities of each holding subsidiary, so that each subsidiary becomes a production base with characteristics, advantages and scale. The group company implements a unified quality management system for each subsidiary, and the group company in charge of the quality of the products .

  According to the person in charge of the provincial food and drug administration, the pilot reform in the “Program” will help strengthen the registrant's life cycle responsibility, encourage innovative R&D and continuous improvement of quality, and further promote the accumulation and optimization of scientific research talents, R&D institutions and innovative enterprises. Market allocation of innovative resources to accelerate the listing of medical devices.At the same time, it is conducive to improving the regulatory system for the registration of medical devices, promoting the standardization of evaluation, and establishing an effective cross-regional post-event supervision method. (All Media Reporter / Wang Jiaxin Correspondent / Shi Yaoxuan)