Good news! The State Council issued a document to assist the development of medical devices to new heights!

The general office of the State Council on the afternoon of March 11th, to the provinces, autonomous regions and municipalities, ministries and agencies directly under the State Council issued a "guidance" to promote the healthy development of the pharmaceutical industry, and vigorously promote and enhance the core competitiveness of China's pharmaceutical industry, promote the sustained and healthy development of medicine industry.

1. To strengthen the technological innovation, enhance the core competitive ability

To promote the innovation ability. Strengthen the reform of system of science and technology, improve the political research medicine collaborative innovation system. To strengthen the original drug, the first generic drugs, traditional Chinese medicine, new formulations, high-end medical equipment innovation ability construction, optimize the allocation of relevant resources, build a rational layout, scientific and efficient technology innovation base.

To accelerate the transformation and upgrading of medical devices. The key part focuses on the development of digital detectors, superconducting magnet, high heat capacity X ray tubes, surgical precision positioning and navigation, data acquisition, processing and analysis of biological three-dimensional (3D) printing technology.

The development of nuclear medical imaging equipment PET - CT and PET - MRI, superconducting magnetic resonance imaging system (MRI), the image of multi-slice spiral CT, ultrasound diagnosis and guided radiation therapy, proton / heavy ion cancer therapy, medical robot, health monitoring, remote medical treatment equipment with high performance.

To promote the full automatic biochemical analyzer and chemiluminescence analyzer, high-throughput gene sequencing, five classification blood cell analyzer immune in vitro diagnostic equipment and reagents industry.

The development of heart valve, cardiac pacemaker, biodegradable stents, artificial joints and spine, and other high-end products with cochlear intervention, and rehabilitation aids in high-end products. Actively explore the medical equipment research and development based on the theory of traditional Chinese medicine.

Two. To speed up the quality upgrading, promote the development of green and safe

To improve the quality standard system. Perfect the standard system of national drug "in" Pharmacopoeia of the people's Republic of China is the core of the implementation of the drug, medical device standards, improve action plan, promote the upgrading of the quality standard of basic drugs, high risk drugs, pharmaceutical excipients, packaging materials and basic, universal and high risk medical instruments, improve the traditional Chinese medicine, national medicine medicine and the technical specifications of pharmaceutical production and quality control standards, improve the standard of rationality and operability, strengthen the authority and seriousness of the standard.

Accelerate the improvement of public service platform, measurement standards, inspection, certification and accreditation, to encourage the construction of the third party quality reliability evaluation platform, promote enterprises to increase investment, improve product reliability.

The implementation of the green transformation and upgrading. Strict management of resource utilization, the implementation of energy system optimization project, technology and equipment to promote energy-saving and land saving, the elimination of backward technology and equipment, strengthen the management of medical consumables recycling high value, improve the utilization efficiency of energy resources and the level of clean production. Strengthen environmental risk management, investigation and management of environmental safety risks, to prevent the occurrence of environmental emergencies.

Three. Optimize the industrial structure, enhance the level of intensive development

The adjustment of industrial structure. Intensifying enterprise organization structure adjustment, promote cross enterprise, cross domain mergers and acquisitions, support for pharmaceutical and chemical, medical devices and equipment, Chinese herbal medicine and traditional Chinese medicine, drugs and preparation of raw materials, production and circulation enterprises combination, formed the integration of upstream and downstream enterprises, solve the small, scattered and disordered.

To promote the coordinated development of regional. Give full play to the advantages of regional resources, constructing new pattern of coordinated development of the eastern and western. The use of funds, the eastern coastal areas of technology, personnel and other advantages, the construction of the international advanced research and development center and headquarters base, the development of high added value, low resource consumption of biological drugs, pharmaceutical formulations and medical devices, to guide the lack of comparative advantage products orderly transfer.

Play the central region of East and west of the regional advantages, according to the carrying capacity of resources and environment, and actively undertake the eastern industrial transfer, relying on the center of the city to carry out high-end pharmaceutical product development and industrialization, to develop medical supplies and other labor-intensive medical products.

To guide the development of industrial agglomeration. In the center of the city has the advantages of talent and technology, the use of electronic information and radiation effects, and other industrial equipment, construction of high-end medical equipment development and industrialization base.

Four. To deepen international cooperation, expand international development space

The optimization of export structure. To establish and perfect the overseas sales and service system, promote the PET - CT, X - ray machine, ECG, ultrasound and other medical equipment exports, and gradually increase the added value of exports.

To promote the international registration of certification. The introduction and cultivation of familiar with the overseas laws and regulations and the market environment of international pharmaceutical registration personnel, improve the ability of international registration. Actively carry out international comparison of measurement related to medical devices. To encourage foreign enterprises to apply for a patent, the formation of overseas patentlayout effectively.

Five. Cultivate new industry, promote the development of intelligent industry

To speed up the medical products focus on the development of digital and intelligent, wearable and portable mobile medical instruments and auxiliary products, promote bio three-dimensional (3D) printing technology, chip data and other new technologies in the application of interventional implantation.

To carry out intelligent medical service. To play a leading role in the quality of health care resources, encourage social forces to participate in the integration of online and offline resources, standardize medical networking and application of health management program (APP).

To guide medical institutions using information technology, intelligent equipment, grassroots, remote and underdeveloped areas, to carry out remote pathological diagnosis, imaging diagnosis, expert consultation, guidance, monitoring operation guidance remote medical service.

Six to strengthen financial support.

To explore the medical equipment manufacturing enterprises, financial and Finance Leasing Company

Eight. The perfect government procurement mechanism

In accordance with the principle of fair competition, open and transparent, perfect the bidding mechanism, gradually to pharmaceutical products into the procurement of public resources trading platform.

Category procurement, set up a scientific evaluation factors, promote the drug and high value standard encoding the procurement of medical supplies, to ensure reasonable prices, security of supply, quality and safety. Standardize the order of competition, breaking the medical product market segmentation and local protection.

According to the regional health planning, formulate and improve medical institutions at all levels with standard, strict control of the super standard, high-grade equipment of fiscal funds procurement is not reasonable.

Strictly implement the provisions of the "government procurement law" of the people's Republic of China, domestic medicines and medical equipment to meet the requirements of the project, the government procurement principle to purchase domestic products, and gradually increase the level of domestic equipment configuration of public medical institutions.

Nine. Deepen the reform of approval

To establish a more scientific and efficient drug and medical device review and approval system. And strictly control the market oversupply, low level repetition, backward production technology products, to speed up the clinical need for innovative medicines, medical equipment products review, guide the orderly development, scientific reporting of the applicant.

To speed up the standardization of clinical application technology to develop a new diagnostic technique. On the innovation of medical devices were identified as genetic testing products, in accordance with the innovative medical device approval process priority review to speed up the innovation of medical services into the health care system, to promote the new technology into clinical use.

Ten. To speed up the construction of talent team

The in-depth implementation of talent development strategy, focusing on drug innovation, medical core hardware and software development, traditional Chinese medicine, pharmaceutical products, international registration and other needs, improve the talent introduction, training, incentive mechanism, create a good environment and makes the best possible use of the.

Continue to implement the "thousand person plan" to attract overseas engineering, product innovation, international registration and other aspects of high-level talents and teams in innovation and entrepreneurship.

Support enterprises and universities, medical institutions of medical engineers training practical talents. Encourage the establishment of training platform for entrepreneurship and Innovation Center talents, strengthen collaborative innovation.

Eleven. Strengthen industrial cooperative supervision

To strengthen the drug and medical device used in the process of management, strengthen the monitoring of adverse drug reactions, the implementation of enterprise products after the listing of the main adverse reaction monitoring responsibility.

Strengthen the drug and medical device regulatory legal system construction, increase flight inspection, promptly investigate and punish illegal enterprises. Strict supervision of safety and environmental protection, and resolutely shut down does not meet the requirements of pharmaceutical enterprises.