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 model of medical device registrants. In addition to self-manufacturing products, medical device registrants may entrust enterprises with corresponding production conditions to produce products. The unit responsible for the entrusted production model of medical device registrants is the State Drug Administration, and the scope of promotion is nationwide. This will undoubtedly bring benefits to the medical device industry.

Medical device MAH as a disruptive reform in the industry

The medical device registrant system is the marketing authorization holder system in the medical device field. Under this system, qualified medical device registration applicants can individually apply for a medical device registration certificate, and then entrust the production to a qualified and productive enterprise, thereby realizing 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 licenses. 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 detrimental 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.

According to "Firestone Creation", there are a total of 45,403 domestic medical device-related companies, of which 16,000 are manufacturing companies, of which more than 90% are small and medium-sized enterprises, less than 10% of enterprises above designated size, and less than 400 companies with an annual output value of over 100 million. And most companies have low technology content, including 16,035 companies related to surgical instruments.

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 enterprise R&D companies to focus on product R&D, opening production to professional service companies, and strengthening innovation Colleagues reduce business costs.

According to statistics, companies that use outsourcing to produce Class II medical devices can save nearly 10 million yuan in three years, and can significantly reduce the company's product listing cycle. According to the first telecentric medical electrocardiograph using MAH, it only took 26 working days from the formal acceptance to the approval to market, which was 82% shorter than the legal working time limit.

In recent years, the domestic medical device market has developed rapidly, from 114.1 billion in 2010 to 370 billion in 2016, 448 billion in 2017, and 500 billion in 2018, with an annual growth rate exceeding 20%. The key development areas of medical equipment, such as diagnostic reagents, imaging equipment, and high-value consumables, are becoming rapidly deployed industrial areas in various regions. In this context, the medical device MAH system will continue to deepen.

Review of medical device MAH related policies

Launched in 2016 by drug marketing license holders. At the end of 2017, the medical device MAH was piloted in Shanghai and expanded to Guangdong and Tianjin in May 2018. In the beginning of 2019, Beijing-Tianjin-Hebei was included in the trial area. The launch of MAH is important for enterprises and government work. Etc. bring new opportunities and challenges.

In 2016, my country began a pilot drug marketing authorization holder system in ten provinces including Shanghai, Jiangsu, and Beijing, allowing drug marketing authorization holders to commission production.

On December 7, 2017, the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" was issued and implemented by the Shanghai Food and Drug Administration. The Shanghai Free Trade Zone takes the lead in piloting the Medical Device Marketing Authorization Holder System (MAH). Applicants for medical device registration in the Free Trade Zone can apply for a medical device registration certificate separately, and then entrust the production to qualified and capable manufacturing enterprises. .

On July 5, 2018, the Shanghai Food and Drug Administration issued an announcement “Expand the pilot reform of the medical device registrant system in this city to the entire city”, allowing medical device registration applicants within Shanghai to entrust Shanghai medical device manufacturers product.

On January 9, 2018, the State Food and Drug Administration issued the "Announcement on the Pilot Program of the Medical Device Registrant System by the Shanghai Food and Drug Administration (2018 No. 1).

On May 24, 2018, the State Council issued the "Further Deepening of China (Guangdong), (Tianjin), (Fujian) Pilot Free Trade Zone Reform and Opening-up Plan", clarifying the reform of the medical device registrant system, and it has been approved to expand from Shanghai to Guangdong and Two places in Tianjin. The scope of the "Separation of Licenses and Licenses" pilot program was further expanded.

On July 5, 2018, the Shanghai Food and Drug Administration issued the "Announcement on Extending the Reform of the Municipal Medical Device Registrant System to the City-wide Implementation" and decided to expand the pilot to the entire Shanghai.

In October 2018, Shenzhen Mindray Technology Co., Ltd. was awarded the first Class II medical device product registration certificate after the implementation of the Guangdong Medical Device Registrant System. The company’s syringe pump became a pilot project in accordance with the "Guangdong Medical Device Registrant System" Implementation Plan" is the first medical device product approved for marketing.

On February 22, 2019, the Chinese government website issued the "Approval of the State Council on Comprehensively Promoting the Comprehensive Pilot Program for the Expansion of the Service Industry in Beijing", agreeing to continue and comprehensively promote the comprehensive pilot of the expansion of the service industry in Beijing. The period is self-approved 3 years from the date. It is proposed to allow Beijing medical device registrants to entrust medical device manufacturers in the Beijing-Tianjin-Hebei region to produce medical devices, for the first time to explore the development of "registration + production" cross-regional industrial chain.

In August 2019, the "Notice on Expanding the Pilot Work of the Medical Device Registrant System" issued by the State Food and Drug Administration further expanded the pilot program of the medical device registrant system. The "Notice" clearly stated that the medical device registrant system will be piloted in 21 provinces, autonomous regions, and municipalities including Shanghai, Tianjin, and Guangdong. These other provinces and cities include Beijing, Hebei, Liaoning, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, etc.

On December 29, 2019, Shanghai, Jiangsu, Zhejiang, and Anhui Food and Drug Administrations jointly issued the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in the Yangtze River Delta Region", allowing medical device registration applicants in the Yangtze River Delta region to entrust the Yangtze River Delta Production enterprises in the region produce products, which also means that the pilot medical device registrant system will be commissioned across regions in the above four provinces and cities.

Consignment-produced medical devices refer to medical devices (including innovative medical devices and samples) classified into the second or third category according to the medical device classification rules, excluding the first category medical devices. Products that belong to the list of medical devices prohibited from commissioned production issued by the former State Food and Drug Administration are not included in the pilot scope in principle.