Inventory and comparative analysis of typical regional policies for the development of my country's medical device industry

In recent years, my country's medical device industry has developed rapidly. The country has intensively issued a series of policy documents on the medical device industry, making important arrangements to improve the supply guarantee capabilities of medical devices and promote high-quality development of the industry. Based on their own characteristics, each province and city has forward-looking thinking and systematic planning, and has effectively explored industrial development paths and industrial policy innovation. This article summarizes and analyzes local medical device policies from the aspects of R&D innovation, review and approval, regulatory services, and market promotion.

一

R&D Innovation

Facing the entire product life cycle of medical devices, many places focus on technical research, clinical research, achievement transformation, and registration in the early development stage of the product. Corresponding policy support provisions will be introduced for all aspects of application, qualification certification, etc., focusing on the construction of an innovation ecosystem throughout the entire process from R&D and innovation to the implementation and transformation of results.

In terms of technical research, focus on model and product innovation. Guangdong Province encourages upstream and downstream medical device companies to engage in collaborative innovation, with a focus on supporting upstream and downstream companies in collaborative technological research. Upstream companies in key materials, core components (components) and other fields can enjoy the same policy treatment; Suzhou City, Shanghai City Qingpu District and other places support the innovation of "integration of medicine and industry" and encourage medical institutions and biomedicine and medical device companies to carry out joint applications and joint research; in addition, Sichuan Province encourages the integration and innovation of AI+ medical devices and supports the use of big data, cloud New technologies such as computing, artificial intelligence, and 3D printing can be used to develop intelligent complete sets of equipment. For innovative products such as the first version of medical and health equipment software that are successfully used, subsidies of up to 5 million yuan can be provided.

In terms of the transformation of scientific and technological achievements, special policies have been introduced to support transformation. Changping District of Beijing is exploring and promoting the construction of biomedical digital facilities, actively preparing to build a clinical medical achievement transformation platform in the capital and a collaborative innovation platform in specific disease fields, and undertaking the overflow of transformation results from major hospitals in Beijing.

In terms of qualification certification, policy guidance and financial support will be strengthened. Jinnan District, Tianjin City has increased support for innovative entities to obtain qualifications, and will provide medical device companies and institutions in the district that have newly obtained qualification certifications such as the International Laboratory Animal Assessment and Accreditation Committee (AAALAC) in the same year, each with a maximum of 1 million yuan. Rewards and compensation.

Table 1 Summary of policies in some regions in the field of R&D and innovation

Source: Firestone Creation compiled based on public information

II

Review and Approval< /p>

In terms of review and approval services, many places have focused on the development demands of enterprises, strengthened the construction of service platforms, highlighted system innovation, goal orientation, and transformation of service methods, promoted the expansion of review and approval resources, service optimization, and efficiency improvement, and assisted the industry. Improve quality and efficiency.

In terms of service platform construction, many places have actively strived for relevant national departments to set up local branches and continue to improve basic review and approval service capabilities. Suzhou strives to establish a national-level Suzhou review and scoring center; the Shanghai Free Trade Pilot Zone actively strives for the National Drug and Device Technical Review and Inspection Yangtze River Delta Sub-Center to establish a liaison service point in the "Blue Bay of Life"; Guangdong Province strives for the national establishment in Guangdong Drug and medical device review and inspection agencies, etc.

In terms of service optimization and improvement, many places have proposed specific innovative measures and work goals. Shanghai proposes joint processing of initial product registration, renewal registration and corresponding changes in production licenses; Sichuan Province conducts rapid review and approval of medical device varieties that comply with relevant regulations. At the same time, various regions have put forward clear requirements for optimizing the review and approval time limit. Guangdong Province and Jiangsu Province require that the review time limit for first registration be shortened from the statutory 60 working days to 40 working days; Sichuan Province requires provincial-level second-category innovative medical treatments For device products, the technical review time limit is reduced to 20 working days.

In terms of on-site inspection mechanisms, many places have innovated inspection and verification workflows for exemptions and exemptions. In Hebei Province and Sichuan Province, companies whose first-time registered medical devices pass system verification and meet other relevant requirements are exempt from on-site inspection of production licenses. Jiangsu Province has implemented a mutual recognition system for inspection results, orderly merging on-site inspections such as drug registration and enterprise production licensing, and reducing the frequency of on-site inspections.

Table 2 Summary of policies in some regions in the review and approval field

Source: Firestone Creation compiled based on public information

Three

Regulatory Services< /p>

Many places have accelerated the implementation of Unique Medical Device Identification (UDI), built UDI traceability platforms, strengthened the supervision of the entire life cycle of medical devices, promoted regulatory exchanges and relaxed market access restrictions.

In terms of device identification, in addition to Class III medical devices, Class II medical devices in Hainan, Fujian, Sichuan, Beijing, Tianjin and other provinces and cities have successively carried out unique identification of medical devices. Tianjin has completed the use of UDI for all Category III and Category II medical devices produced in the city, first-level Beijing-Tianjin-Hebei joint procurement imports and domestic varieties not produced in this city, and encourages the use of UDI coding for Category I medical devices. In addition, Tianjin, Shenzhen and other provinces and cities have established online UDI traceability platforms to improve the efficiency of medical device supervision. Shenzhen City has established the "Shenzhen Medical Device Unique Identification Traceability Platform" to provide technical support for the implementation of UDI and to clearly and intuitively display the full life cycle flow of UDI.

In terms of regulatory exchanges, Guangdong Province emphasizes drawing on advanced international management experience, strengthening research on international regulatory laws, promoting overseas on-site inspections of imported key components and key raw materials used in the production of medical devices, and ensuring the quality and safety of medical device products. .

In terms of market access, Beijing is actively seeking policy support related to pilot projects for medical device service stations and pilot innovation pilots for the supervision of innovative products such as artificial intelligence medical devices to relax market access restrictions.

Table 3 Summary of policies in some regions in the field of regulatory services

Source: Firestone Creation compiled based on public information

Four

Marketing

Focusing on volume procurement, innovative product applications, product integration innovation, product competitiveness, etc., many places have proposed corresponding support measures to promote the development of independent innovative medical device products and cultivate the backbone of local brands with international influence. enterprise.

In terms of bulk procurement, many places have chosen medical consumables with larger clinical usage, higher purchase amounts, more mature clinical use, clear classification catalogs, and no supporting equipment to give priority to explore and carry out bulk procurement to promote the health of the industry. To develop in an orderly manner and reduce the medical expense burden of the people. Tianjin City has proposed that by the end of the "14th Five-Year Plan", more than 500 drug varieties will be purchased in bulk, and more than 5 categories of high-value medical consumables will be purchased. Hebei Province independently carries out or participates in cross-regional procurement alliances such as the "Beijing-Tianjin-Hebei" Procurement Alliance to carry out centralized bulk procurement of medical consumables that are outside the scope of centralized mass procurement by national organizations.

In terms of the application of innovative products, many places have proposed supporting innovative products to enter medical insurance, hospitals, Internet connection, etc., to accelerate the promotion and use of products. Jiangsu, Zhejiang, Sichuan and other regions have proposed measures to optimize the online review process of pharmaceutical and equipment recruitment platforms and improve the procurement process; Suzhou, Shanghai, Sichuan, Hangzhou, Ningbo and other regions have proposed to prioritize innovative products into the medical insurance catalog; Beijing has accelerated the formation of artificial intelligence Regarding the charging model for medical device products, commercial insurance pilots for medical insurance payment for innovative products have been launched; Zhejiang Province, Shanghai and other regions have actively explored pilots for purchasing services for artificial intelligence-assisted diagnostic systems.

In terms of cultivating new business formats, many places have proposed promoting the integrated development of new generation information technology and medical device industries. Beijing supports the upgrading and transformation of artificial intelligence-enabled medical equipment, builds smart hospitals, cultivates digital medical benchmark companies, and establishes medical device marketing service platforms; Hangzhou builds medical and health big data centers and open infrastructure to encourage new digital health services.

In terms of market development, many places focus on improving the international competitiveness of their products. Beijing promotes the establishment of a medical device marketing service platform to help companies develop markets; Shanghai, Tianjin, and Suzhou allow companies to obtain approvals from the United States (FDA), Europe (EMA), Japan (PMDA) and other agencies, and implement them in relevant foreign markets Medical device companies selling medical devices will be provided with subsidies, of which Shanghai can provide one-time financial support of up to 10 million yuan.

Table 4 Summary of policies in some regions in the field of marketing

Source: Firestone Creation compiled based on public information

Five

Summary

In recent years, the state has significantly increased its emphasis on the medical device industry, providing greater support at the policy level, encouraging the domestic medical device industry to accelerate innovation, become bigger and stronger, and accelerate the realization of import substitution; at the same time, relevant departments are also constantly Deepen institutional reform to promote and ensure the healthy development of the medical device industry. Against this background, in the coming period, the industrial support policies of various regions will continue to focus on expanding industrial scale, supporting key enterprises, supporting innovative products, innovating administrative management, etc., giving full play to the advantages of the local medical device industry, highlighting key points, supplementing Eliminate shortcomings, improve the ecology, strive to integrate the industrial chain, improve the value chain, and achieve high-quality innovative development of medical devices.