Medical network - on November 8th, ministry of industry and the national development and reform commission, ministry of science and technology, ministry of commerce and national development planning commission, and drug safety administration jointly issued the pharmaceutical industry development planning guide (hereinafter referred to as the "guidelines"), to speed up the "much starker choices-and graver consequences-in" pharmaceutical industry from large to strong change.
The guide is put forward, to focus in the pharmaceutical industry to promote the development of the six areas, including biological medicine, chemical medicine varieties, high quality, high-performance medical equipment, new adjuvant material and pharmaceutical equipment. In six areas, three related to medical apparatus and instruments is behind, just share half.
Specific to each YiXie points area, key development object, respectively, as follows:
A, medical apparatus and instruments
1, medical imaging equipment.
Focus on developing high field superconducting magnetic resonance (NMR) and superconducting magnetic resonance imaging system, specialized high-end CT equipment, multimodal fusion PET - CT and PET - MRI molecular imaging equipment, high-end color doppler flow imaging (cdfi) and intravascular ultrasound, X-ray machine vascular digital subtraction angiography (DSA), hd electronic endoscope, etc.
Improve the level of core parts production, mainly including CT tube, superconducting magnets, magnetic resonance (NMR) and radio frequency coil, PET crystal detector, ultrasonic single crystal probe, two-dimensional array probe, such as the new probe, X-ray flat-panel detector, endoscopic three chip camera system, etc.
2, in vitro diagnostic products.
Focus on developing high flux, blood cell analyzer, biochemical analyzer, immune analyzer whole assembly line (TLA) and related laboratory automation test analysis reagent, the single molecule gene sequencing machine and other molecular diagnostic instrument, a new real-time detection equipment (POCT).
To strengthen the information management system of in vitro diagnostic equipment, reagent, software and data analysis system of integrated innovation, speed up the testing standards of reagent, resource development and the development of new reagents with standard substance.
3, treatment equipment.
Focus on developing high energy linear accelerator and imaging guided radiotherapy equipment, orthopaedic robot and laparoscopic surgery, hemodialysis equipment and consumables, artificial liver blood purification equipment and consumables, eye laser treatment systems, high-end treatment of breathing machine, mobile emergency ICU system, defibrillation apparatus, the doctor of traditional Chinese medicine treatment equipment, etc.
4, implanted in products and medicinal materials.
Focus on developing the whole degradation of coronary stents, heart valves, biodegradable closure, reusable catheter interventional therapeutic apparatus, artificial joints and spine, 3 d printing orthopedic implants and tissue organ regeneration and repair material, heart pacemakers, implantable left ventricular assist device, the brain pacemaker, cochlear implants, dental implants, artificial crystal, eye functional dressings, biodegradable rapid hemostatic materials and medical adhesives and so on.
5, mobile medical products.
Application development health data, focus on developing telemedicine system, wearable physiological information monitoring equipment, has the function of cloud services and artificial intelligence household, provide for the aged, rehabilitation equipment, can provide health advice, online booking triage, case follow-up, inspection results query applications such as health management information system.
Developing a new type of electrophysiological wearable medical devices using sensors, flexible display device, high performance battery such as the core of general parts.
Second, the packaging system and dosing device
To accelerate the development of product packaging system upgrades, application of new materials, high safety, quality, good performance to phase out quality safety risk big varieties, the key to speed up the injection packing by the low borosilicate glass bottles to neutral borosilicate glass transformation, development of syringes, infusion bags, bags and other products using the ring of olefin polymer, styrene thermoplastic elastomer and other new materials, easy tide can be oxidized drugs with high barrier material, improve the medical level of polypropylene, polyethylene and halogenated butyl rubber quality level.
Development of new packaging system and dosing device, with a specific function, meet the technical requirements, improve patient compliance, drug safety, special focus on developing aerosol mist and powder dosing device, self dosing syringe, potting syringes, automatic mix medicine device, such as the new syringe, multicellular bag and the removal of insoluble particles functional infusion packaging, with the function of memory function, the quality monitoring of intelligent packaging system, age and family five child safety packaging friendly packaging.
Three, pharmaceutical equipment
1, high-end equipment.
Key development slow controlled release, transdermal absorption, pink mist new preparation process equipment, large-scale bioreactors and subsidiary systems, protein separation and purification equipment efficiently, flexible sterile products production lines, production equipment, continuous solid preparation powder engineering equipment, advanced foreign optical detection equipment, high-speed intelligent packaging production line, applicable to special post industrial robots, etc.
2, equipment technology.
Improve pharmaceutical equipment integration, continuous, automation, informationization, intelligent level.
Systematic complete sets of equipment development, provide the overall solution.
Strengthen the on-line detection, on-line monitoring, the cleaning and disinfection of the reigning, high technology applications, such as a hermetic and isolation of improve equipment since diagnosis, adaptive and network communication ability, improve the openness and compliance of the equipment.
Expand the application of industrial Ethernet technology, digital signal processing technology and the programmable controller, for process control, optimization operation, intelligent management, create conditions.
In addition, the guide also suggested that during the period of "much starker choices-and graver consequences-in" in the field of medical apparatus and instruments to implement the following main tasks:
1, enhance the capacity of industrial innovation
To strengthen the core technologies and key components development of medical equipment, enhance the level of integrated innovation capability and manufacturing. Construction of medical device manufacturing innovation center.
Standard medical instrument clinical trial base (GCP) base construction and management.
2, YiXie upgrading product quality
The implementation of the national medical devices standards improve action plan and carry out with the international standard for standard, technical requirements, set in medical equipment inspection to promote enterprises to improve product design, manufacturing process and quality control, improve the stability and reliability of the medical equipment.
Promote fundamental, generality and high-risk medical devices quality standard upgrade, support medical equipment enterprises to raise the level of technology, to carry out the clinical quality authentication, improve the stability and reliability.
Encourage the development of well-known brands of medical equipment.
3, improve supply security capabilities
Encourage enterprises in the development of high performance medical devices at the same time, the existing products to carry out various forms of innovation, improve patients experience, and improve the patients compliance, meet the multi-level, personalized market demand, promoting China's return to tourists overseas purchase demand.
Development of domestic medical device products, improve product design, functional positioning and packaging forms, meet the demand of consumer self health management.
4, medical equipment automation production workshop construction
Support the construction of more than 10 according to the characteristics of discretization of medical equipment manufacturing automation production demonstration workshop, change most of the medical equipment is given priority to with artificial assembly, test condition, raise the level of mechanical assembly, automated materials distribution, quality inspection, and customized production, improve the stability and reliability of the medical equipment system.
5, improve the level of internationalization
To expand the export scale of medical equipment, with the aid of electronic information, equipment manufacturing industry in China, foster the competitiveness of the medical equipment products, set up overseas technical service network, vigorously develop the international market.
Six new forms, expand new areas of development
Driving home, provide for the aged, rehabilitation medical equipment development and application, to meet the need of the aging of the population.
Support gene sequencing, tumor immunotherapy, stem cell therapy, drug along with the development of new medical technology, such as diagnosis, improve the industry admittance policy, in order to strengthen the management of clinical application, to promote the technology to meet the needs of clinical, with international development pace.
Vigorously develop the third party maintenance service of medical equipment, encourage the production of medical equipment, pharmaceutical equipment companies to carry out extension services, to shift from products to provide the overall solution, construction of the third party inspection center, the image center, dialysis center and pathology, etc.
7, perfect price, procurement policy
Specification and to promote high value medical consumables procurement sunshine, improvement of large medical equipment allocation policy and medical service price project management, promote new medical equipment in a timely manner in accordance with provisions in clinical use. |
