Source: China Medical Devices Author: Sai Jinhua

 

On July 25, the National Development and Reform Commission issued the "Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry" (hereinafter referred to as the "Plan").

 

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

 

The state takes innovation and upgrading as the top priority of the pharmaceutical industry, and specific to the medical device industry,5 categories and 26 small categories of medical devices will accelerate the transformation and upgrading, and become the focus of future national support for development.. Includes:

 

1. Key developmentDigital detector, superconducting magnet, high heat capacity X-ray tubeand other key components,Surgical precision positioning and navigation, data acquisition, processing and analysis, biological three-dimensional (3D) printingtechnology such.

 

2. DevelopmentPET-CT and PET-MRI of nuclear medicine imaging equipmentSuperconducting magnetic resonance imaging system (MRI), multi-slice spiral CT, color ultrasound diagnosis, image-guided radiotherapy, proton/heavy ion tumor therapy, medical robot, health monitoring, telemedicinesuch as high-performance medical equipment.

 

3, to promoteAutomatic biochemical analyzer, chemiluminescence immunoassay analyzer, high-throughput gene sequencer, five classification blood cell analyzerSuch as in vitro diagnostic equipment and supporting reagents industrialization.

 

4-DevelopmentHeart valves, pacemakers, fully degradable vascular stents, artificial joints and spine, cochlear implantssuch as high-end plant intervention products, andRehabilitation AidsHigh-end products.

 

5. Actively exploreMedical Devices Based on Traditional Chinese Medicine TheoryR & D.

 

This key task is clearly led by the Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Science and Technology, and the National Defense Science and Industry Bureau, with the participation of the Health and Family Planning Commission, the Food and Drug Administration, the Bureau of Traditional Chinese Medicine, the Ministry of Civil Affairs, the Disabled Persons' Federation, the Chinese Academy of Sciences, and the General Administration of Sports.

 

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

 

1) Strengthen the construction of high-end medical device innovation capacity, optimize the allocation of scientific and technological resources, and build a scientific and efficient scientific and technological innovation base with reasonable layout;

 

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

 

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

 

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

 

5) Promote coordinated regional development. The eastern coastal areas will build international advanced R & D centers and headquarters bases, develop medical devices with high added value and low resource consumption, and guide the orderly transfer of products that lack comparative advantages. The development of labor-intensive medical equipment products such as medical consumables in accordance with local conditions in the central region;

 

6) In central cities with talents and technological advantages, use the radiation effect of electronics, information and equipment industries to build high-end medical device research and development and industrialization bases;

 

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

 

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

 

9) According to the affordability of the medical insurance fund, timely include eligible, reasonably priced, and independent intellectual property rights drugs, medical devices, and diagnosis and treatment items into the scope of medical insurance payment in accordance with the prescribed procedures;

 

10) Establish and improve overseas sales and service systems, promote the export of medical devices such as PET-CT, X-ray machines, electrocardiographs, and B- ultrasound, and gradually increase the added value of exports;

 

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

 

12) Cultivate new industries and promote industrial development. Accelerate the digitization and digitization of medical device products, focus on the development of wearable, portable and other mobile medical and assistive device products, and promote the application of new technologies such as biological three-dimensional (3D) printing technology and data chips in implant interventional products.

 

In addition to key tasks, the Program proposes six major policy safeguards., including:To study and formulate innovative and excellent medical device product catalogues before the end of 2017; To formulate and improve the medical device equipment standards for medical institutions at all levels by the end of 2017; To promote the completion of the standardization of high-value medical consumables procurement codes by the end of 2016Wait.

 

The specific task division and schedule of these six policy measures are as follows:

 

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