A few days ago, the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the Health and Family Planning Commission, and the State Administration of Drug Administration jointly issued the "Guide to the Development Planning of the Pharmaceutical Industry" (hereinafter referred to as the "Guide"), which aims to accelerate the transformation of the pharmaceutical industry from large to strong during the 13th five-year Plan.

 

The "Guide" proposes to focus on promoting the development of six major areas in the pharmaceutical industry, including biological drugs, new varieties of chemical drugs, high-quality traditional Chinese medicine, high-performance medical devices, new auxiliary materials and pharmaceutical equipment. Of the six major fields, the latter three are related to medical devices, accounting for exactly half.

 

Specific to the various medical equipment sub-fields, the key development targets are as follows:

 

1. medical devices

 

1. Medical imaging equipment.

 

Focus on the development of high-field superconducting magnetic resonance and Junior College superconducting magnetic resonance imaging system, high-end CT equipment, multi-modal fusion molecular imaging equipment PET-CT and PET-MRI, high-end color Doppler ultrasound and intravascular ultrasound, vascular digital subtraction X-ray machine (DSA), high-definition electronic endoscope, etc.

 

To improve the production level of core components, the focus includes CT tube, magnetic resonance superconducting magnet and radio frequency coil, PET crystal detector, ultrasonic single crystal probe, two-dimensional array probe and other new probes, X-ray flat panel detector, endoscope three-chip camera system, etc.

 

2, in vitro diagnostic products.

 

Focus on the development of high-throughput biochemical analyzer, immune analyzer, blood cell analyzer, the whole laboratory automation test analysis line (TLA) and related reagents, single molecule gene sequencer and other molecular diagnostic instruments, new real-time detection equipment (POCT).

 

Strengthen the integration and innovation of in vitro diagnostic equipment, testing reagents, information management software and data analysis systems, and accelerate the establishment of testing reagent standards, the development of reference materials for traceability and the development of new reagents.

 

3. Treatment equipment.

 

Focus on the development of high-energy linear accelerators and image-guided radiotherapy devices, orthopedic and laparoscopic surgery robots, hemodialysis equipment and consumables, artificial liver blood purification equipment and consumables, ophthalmic laser treatment systems, high-end treatment ventilators, mobile ICU emergency systems, defibrillators, Chinese medicine treatment equipment, etc.

 

4. Implantation of interventional products and medical materials.

 

Focus on the development of fully degradable coronary stents, heart valves, degradable occluders, reusable interventional catheters, artificial joints and spine, 3D printed orthopedic implants, tissue and organ induction regeneration and repair materials, cardiac pacemakers, implantable left ventricular assist devices, brain pacemakers, cochlear implants, dental implants, ophthalmic artificial crystals, functional dressings, degradable rapid hemostatic materials and medical adhesives.

 

5, mobile medical products.

 

Development and application of health care big data, focusing on the development of telemedicine systems, wearable physiological information monitoring equipment, home, old-age and rehabilitation equipment with cloud services and manual functions, and health management information systems that can provide health consultation, online appointment triage, case follow-up, inspection results query and other applications.

 

Development of new electrophysiological sensors, flexible display devices, high-performance batteries and other core general-purpose components used in wearable medical devices.

 

2. packaging system and drug delivery device

 

Accelerate the upgrading of packaging system products, develop new materials with high applicability and good quality and performance, phase out varieties with high quality risks, focus on accelerating the conversion of injection packaging from low borosilicate glass bottles to neutral borosilicate glass bottles, develop new materials such as cycloolefin polymers and styrene thermoplastic elastomers used in syringes, infusion bags, blood bags and other products, and high barrier materials for moisture-prone and oxidizable drugs, improve the quality level of pharmaceutical grade polypropylene, polyethylene and halogenated butyl rubber.

 

Develop new packaging systems and drug delivery devices, provide specific functions, meet the technical requirements of preparations, improve patient compliance, ensure drug use, focus on the development of special drug delivery devices for aerosols and powder mist, self-administration syringes, pre-filled syringes, automatic drug mixing devices and other new syringes, multi-chamber bags and infusion packaging with the function of removing insoluble particles, and a chemical packaging system with memory function and quality monitoring function, children's packaging and elderly-friendly packaging for commonly used drugs in families.

 

3. Pharmaceutical Equipment

 

1. High-end equipment.

 

Focus on the development of new preparation process equipment such as slow and controlled release, transdermal absorption, powder mist, large-scale bioreactors and auxiliary systems, high-efficiency protein separation and purification equipment, flexible sterile preparation production line, continuous solid preparation production equipment, advanced powder engineering equipment, foreign body optical detection equipment, high-speed packaging production line, industrial robots suitable for posts, etc.

 

2. Equipment technology.

 

Improve the level of integration, continuity, automation, informatization and industrialization of pharmaceutical equipment.

 

Develop systematic complete sets of equipment and provide overall solutions.

 

Strengthen the application of online testing, online monitoring, in-place cleaning and disinfection, high containment and isolation technologies, improve the self-diagnosis, self-adaptation and network communication capabilities of equipment, and improve the openness and compliance of equipment.

 

Expand the application of industrial Ethernet technology, digital signal processing technology and programmable controllers to create conditions for process control, optimized operation and management.

 

In addition, the "Guide" also proposed that during the 13th Five-Year Plan period, the following main tasks should be implemented in the field of medical devices:

 

1. Enhancing industrial innovation capacity

 

Strengthen the development of core technologies and key components of medical devices, and improve integrated innovation capabilities and manufacturing levels. Construction of medical device manufacturing innovation center.

 

Standardize the construction and management of medical device clinical trial base (GCP base).

 

2, medical product quality upgrade.

 

Implement the national medical device standard improvement action plan, carry out benchmarking with international standards, formulate technical requirements for in-use medical device inspection, promote enterprises to improve product design, manufacturing process and quality control, and improve the stability and reliability of medical equipment.

 

Promote the upgrading of basic, universal and high-risk medical device quality standards, support medical device enterprises to improve the level of process technology, carry out product clinical quality verification, improve stability and reliability.

 

Encourage the development of well-known brands of medical devices.

 

3, improve the supply guarantee capacity.

 

While developing high-performance medical devices, enterprises are encouraged to carry out various forms of micro-innovation on existing products, improve patient experience, improve patient compliance, meet multi-level and personalized market demand, and promote the return of overseas purchase demand of Chinese tourists.

 

Develop household medical equipment products, improve product design, functional positioning and packaging forms to meet consumer self-health management needs.

 

4, medical equipment automation production workshop construction.

 

Support the construction of more than 10 automated production demonstration workshops for the characteristics of discrete manufacturing of medical devices, change the situation of manual assembly and manual testing of most medical devices, improve the level of mechanical assembly, realize automated material distribution, quality inspection and customized production, and systematically improve the stability and reliability of medical devices.

 

5. Improve the level of international development

 

Expand the scale of medical equipment exports, with the help of my country's electronic information and equipment manufacturing industry foundation, cultivate the competitiveness of medical equipment products, establish an overseas technical service network, and vigorously explore the international market.

 

6. Expand new areas and develop new formats

 

Promote the development and application of household, old-age and rehabilitation medical devices to meet the needs of an aging population.

 

Support the development of new medical technologies such as gene sequencing, tumor immunotherapy, stem cell therapy, and drug companion diagnosis, improve industry access policies, strengthen clinical application management, promote various technologies to adapt to clinical needs, and keep up with international development.

 

We will vigorously develop third-party maintenance services for medical devices, encourage medical device and pharmaceutical equipment enterprises to carry out product extension services, shift from providing products to providing overall solutions, and build third-party inspection centers, imaging centers, dialysis centers and pathology centers.

 

7, improve the price, procurement and other policies

 

Standardize and promote the sunshine procurement of high-value medical consumables, improve the allocation policy of large-scale medical equipment and the management of medical service price items, and promote the timely entry of new medical devices into clinical use in accordance with regulations.

 

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