National key development: 5 categories of 26 small class medical devices

The first key task listed in the “Proposal” to promote the healthy development of the pharmaceutical industry is to “strengthen technological innovation and improve core competitiveness”.

The country regards innovation and upgrading as the top priority of the pharmaceutical industry. Specific to the medical device industry , the five major categories of 26 small-scale medical devices will accelerate the transformation and upgrading, and become the focus of future national support development, including:

1. Focus on the development of key components such as digital detectors, superconducting magnets, high-heat capacity X-ray tubes, precise positioning and navigation, data acquisition and processing, and bio-three-dimensional (3D) printing.

2. Development of nuclear medicine imaging equipment PET-CT and PET-MRI, superconducting magnetic resonance imaging system (MRI), multi-slice spiral CT, color ultrasound diagnosis, image guided radiotherapy, proton/heavy ion tumor treatment, medical robot, health High-performance medical equipment such as monitoring and telemedicine .

3. Promote the industrialization of in vitro diagnostic equipment and supporting reagents such as automatic biochemical analyzer, chemiluminescence immunoassay analyzer, high-throughput gene sequencer , and five-class blood cell analyzer.

4, the development of heart valves, cardiac pacemakers, fully degradable vascular stents, artificial joints and spine, cochlear implants and other high-end implant intervention products, as well as high-end products in rehabilitation aids.

5. Actively explore the development of medical devices based on the theory of traditional Chinese medicine.

The key tasks were clearly led by the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Science and Technology, and the National Defense Science and Technology Bureau. The Health Planning Commission, the Food and Drug Administration, the Chinese Medicine Bureau, the Ministry of Civil Affairs, the Disabled Persons' Federation, the Chinese Academy of Sciences, and the General Administration of Sports participated.

Other key tasks related to the promotion of the pharmaceutical industry directly related to medical devices include:

1) Strengthen the construction of high-end medical device innovation capabilities, optimize the allocation of scientific and technological resources, and create a rational, scientific and efficient scientific and technological innovation base;

2) Implement medical device standards to improve the action plan and promote the upgrading of quality standards for basic, versatile and high-risk medical devices;

3) Strengthen the management of high-value medical consumables recycling;

4) Promote cross-industry and cross-sector mergers and acquisitions of enterprises, support the strong combination of pharmaceutical and chemical, medical equipment and equipment, production and distribution enterprises, form an upstream and downstream integrated enterprise group, and truly solve the problems of small, scattered and chaotic;

5) Promote regional coordinated development. The eastern coastal areas will build internationally advanced R&D centers and headquarters bases to develop medical devices with high added value and low resource consumption, and guide the products that lack comparative advantage to be transferred out in an orderly manner. The central region will develop labor-intensive medical device products such as medical consumables according to local conditions;

6) In the central cities with talents and technological advantages, use the radiation effects of industries such as electronics, information and equipment to build high-end medical device R&D and industrialization bases;

7) Promote the establishment of a source code open system for communication protocols, fault feedback, detection and maintenance of medical equipment , and encourage the development of third-party professional maintenance and after-sales service teams;

8) Closely link up medical reform and create a good market environment. Promote the sharing of equipment for all types of medical institutions, promote mutual recognition of inspection results among medical institutions, reduce duplication of inspections, and reduce the medical burden of patients;

9) According to the medical insurance fund's ability to withstand, timely submit the drugs, medical devices and medical treatment items that meet the conditions, reasonable prices and have independent intellectual property rights into the scope of medical insurance payment according to the prescribed procedures;

10) Establish and improve overseas sales and service systems, promote the export of medical equipment such as PET-CT, X-ray machine, electrocardiograph, B-ultrasound, etc., and gradually increase the added value of exports;

11) Actively carry out international comparisons of measurement related to medical devices;

12) Cultivate emerging formats and promote the development of industrial intelligence. Accelerate the digitization and intelligence of medical device products, focus on the development of mobile medical and auxiliary device products such as wearable and portable, and promote the application of new technologies such as bio-three-dimensional (3D) printing technology and data chip in implant intervention products.

In addition to the key tasks, the Program proposes six policy safeguards, including: research and development of innovative and excellent medical device catalogues by the end of 2017; and development and improvement of medical device standards at all levels of medical institutions by the end of 2017; Before the promotion of high-value medical supplies procurement coding standardization and so on.

Harbin Huasil Company produces electro-hydraulic operating tables, gynecological laboratories, examination beds, ENT examination beds, head frames, leg supports, imported head frames Mayfield, traction frames, gel pads, body pads, shadowless lamps and other products. Huasil processing imported surgical bed accessories, imported brands such as Mitutoyo, Mayfield, Maikewei, Mediland and Yakemeide.

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