2008 domestic medical equipment market "new" things eye-catching

Regulatory efficiency is the key to innovation – innovation, tools for innovation.

In 2008, China medical device regulatory authorities at all levels to implement the scientific development concept as a fundamental, explore new ideas, and actively explore new measures of supervision, including some work on the improvement of the medical devices regulatory work is of great significance. In the whole country, Zhejiang Province has been in the medical device regulatory work, this is not the same as the provincial supervisory innovation are inseparable. In June 2008, for use on medical device link, the Zhejiang Province food and Drug Administration issued the Zhejiang Province medical institutions of medical device use monitoring plan, comprehensive start to medical institutions use supervision of medical devices, and strive to pass 3 ~ 5 years, the progressive realization of the medical devices used in quality control. Plan from the legitimacy of the identification of products, whether implanted devices can be traced back to promote such as medical institutions in the internal management system implementation; to implanted medical devices, and other serious medical device adverse event occurrence, high incidence of varieties to focus and strengthen medical device adverse event of medical institutions and medical device safety accident reporting system implementation; to use the first aid equipment safety testing-breakthrough, improve medical institution self-evaluation capacity of medical device safety conditions. Supervision of the production chain, Zhejiang Province Taizhou's innovation capacity and intensity. It draws on pharmaceutical production quality Attorney system experience, focused on the regulation of medical equipment manufacturing enterprises in key position quality authorization system pilot. The system is based on medical device company existing organizational structure, quality system documents and human resource allocation, guide enterprises to carry out effective quality management, and strive to build enterprise authorized internal responsibility system from top quality and the level of bi-directional between the system of supervision and effectively strengthen the enterprise managers at all levels of law abiding consciousness, quality awareness, responsibility consciousness, enterprise standard operating quality management system. As the capital, to create national first-class monitoring performance, Beijing drug authority focuses on key areas of regulatory innovation. For example, in the medical device advertising review work great for 1014 volume for volume and a one-time pass rate is not high, the Council promoting medical device advertising review system reform, implementation of technical administrative separation, innovative medical equipment review method, really ensure that medical device advertising review "better and faster". In medical device technology review, its medical device technology review centres active in research, development of China's first in vitro diagnostic reagent management information system by national copyright-protected. In Beijing during the Olympic Games, Beijing's Xicheng branch innovative regulatory approach, "face to face, shoulder to shoulder, back to back, the work of the ad-hoc", overall strengthening of medical device regulation. "Face-to-face" that is passed to form of will on behalf of the Institute, on enterprises and medical institutions related to regulatory training, help businesses find and repair management vulnerability; "shoulder to shoulder" with the branch of the Department is comprised of the Joint Inspection Unit, on key lines, focus sheao regions for occasional, non-regular "bundled" check, improve the efficiency of supervision; "back-to-back" that is, give full play to the drug levels the role of the social supervision network, carrying out full coverage of the deities, found the problem in a timely manner; "point-to-point" i.e. the responsibility of departments and responsible leadership, enhancing the focus area, the main risk point of control. Innovative, pioneers, more than Zhejiang, Beijing and other places. 2008 Guangdong Province food and drug administration, the national lead in the establishment of medical device quality system review system, medical device regulatory focus from products to the product before the review process, the establishment of medical supervision over quality system management for the effective functioning of the mechanism, and introduced the Guangdong medical device manufacturing enterprise quality system review interim provisions on the scope of the review, review criteria, review the processing methods as well as the review of the requirements, and so expressly provided. Quality system review system, on the one hand, enables the quality system of checks in line with the production of the actual situation, you can discover quality system functioning, effective after the issue of regulating medical device manufacturing order; on the other hand, reinforces the product control and quality management association, to promote and standardize management, improve enterprise technology and production conditions is a powerful impetus. At the same time, the review system improves the quality check of legal effect, the effective suppression of third-party certificate authority is not responsible, the enterprise is not honest product quality risks. In fact, to improve regulatory effectiveness, are exploring a new supervisory initiatives: Jiangsu Province food and drug administration departments at all levels on all classified as integrity unit of the medical device manufacturing enterprise, in the reception, data review, product testing, field inspections, quality system assessment and other administrative approval given priority handling; the establishment in Zhangjiajie city, Hunan province medical devices regulatory electronic databases; tract in the County of Heilongjiang province on large medical device implementation of the "household register" management; Shandong linyi County uses "information technology" on the high risk of implanted medical devices achieve dynamic supervision; and so on. Innovation, not only in parts of the regulatory authorities to promote medical supervision as a power source, the army has become an increasing diversification of military tasks complete protection capacity of the hand. In 2008, the General Logistics Department of the Ministry of health drugs equipment examination to adapt military reform development trend, according to the actual forces, in the play to social advantages on the joint army and the exploration of the protection of, and formed a three-level maintenance system (i.e. the base maintenance system, intermediate maintenance system and base-level maintenance system, the army has minor repairs, maintenance, the theaters, the unit has established a professional repair agencies, have the ability to repair, for larger failure by that the coordination of local manufacturers timely maintenance support); at the same time, launched our first to increase the efficiency of the forces of medical equipment maintenance as the target, to information technology as a means of integrated service assurance platform — "the army's medical equipment maintenance service hotline," "the army's medical device remote video repair information system", in the army units, management, maintenance organisations and suppliers between bridges the information. This innovative, not only will the troops went out of the previous failure to bring medical equipment maintenance, and a new military joint security integration. Efficiency enhancement due to reforms, problem solvingIs innovation. In the advocate scientific development in 2008, China medical device regulation can be described as "new" means a lot.

2008 medical device research and development of the "new" sound capture people healthy and rapid development of industry, the core driving force is the research and development.

Grab this, 2008 China medical device industry research new technologies, the introduction of new products as the development of the play, the entire industry highlights swimmers, take the "new" sound. This year, my first pacemaker post-marketing randomized, prospective clinical study results. This clinical study is the first strictly comply with international standards program to perform a clinical study of large-scale equipment, using the same with the European electronic data management systems and analysis methods, from the University of Hong Kong's independent research group to conduct a comprehensive analysis of the data. It is reported that the first time for Chinese patients with cardiac pacemakers landmark clinical studies, the data collected will help our doctors implant device choice, clinical practice and patient management with the world, you can be guided by evidence-based medicine to improve clinical treatment method, allowing patients to benefit. The results will also provide clinical Chinese doctors guided practice and Government health care protection laws provide important basis. This year, the Shenyang-Dalian endoscope co., Ltd. with nearly 6 years successfully developed entirely with China's independent intellectual property rights of Medical Endoscope protection system. The products mainly used disposable supplies and the corresponding instruments to the endoscope from microscopic tube clamp Dow to mirror the surface in all protected, and the patients body cavities, body fluids, blood isolation. The project for a total of 22 patents protect. The experts believe that the product performance superior to currently immature similar foreign products, a better operation, comfort and reliability of disinfection, you can increase the mirror of life, effectively reducing the risk of iatrogenic cross-infection, its technology reached the international advanced level. This year, the world's first block can guide the individualized drug therapy in hypertension gene chip in Changsha through technology organization of acceptance. The gene chip from Central South University after 20 years of successful development. Gene chip is in recent years, the world's rapidly evolving high-throughput detection technology, it will be a large number of probes are regularly arranged in a piece, and the processed sample specimens for hybrid, through testing gets samples contains genetic information. This year, Hubei linking biological materials co., Ltd. "allogeneic bone implant materials" by Wuhan technology, organization and identification. Experts believe that the results are in allogeneic bone developed by frontier level, in shaping the product design and development, reduce the ImmunoGen, maintain biological activity and prevent infection in an innovative and effective improvements. This year in mid-October, at the China International hi-tech fair, part of the medical device innovation results in high-profile appearance. Highlights: the national 863 plan project outcome — three-dimensional reconstruction of medical images visualization simulation operation system. The system to improve the quality of teaching and training operations, reduce intraoperative decision-making time and reduce operation risks and to improve doctor-patient relationship, there are obvious. The comparison of domestic and foreign-related literature searches, three-dimensional reconstruction of medical images visualization simulation surgery system is currently the leading domestic and international advanced level. Highlights: Shenzhen Hua by Kang company developed China's first ultra high throughput DNA sequencing instrument. The sequencing instrument for fast and accurate determination of human and animal genome sequencing, advance through sort control found human and wildlife diseases and physiological changes. The instruments available to achieve the national gene sequencing equipment and technology "zero breakthrough", broke international monopoly. As China Hi-Tech fair theme — "Science and technology improve people's livelihood, innovation and change the world", China medical device research and development in the area of achievement, will enable China medical device industry full of vitality. In 2008, in collaboration with the "new" medical devices road smooth SFDA has always attached great importance to the relevant departments, as well as in foreign countries and international organizations. In 2008, China medical device regulation in advance of the effective implementation of international collaboration, continue to intensify cooperation with foreign countries, by opening up new avenues of collaboration, enhance understanding and cooperation on all sides. This international collaboration not only help improve medical devices safety regulatory standards and contribute to the promotion of Chinese medical device products to improve the quality of production, while at the same time, also enhances our international medical devices safety collaboration. In international collaboration, and the United States contact deeper, the effect is obvious. 17 March, Chiam medical device security protocol first performance held in Beijing, the two sides of the People's Republic of China State food and drug administration and the United States of America Department of health and human services regarding drugs, medical devices safety agreement (hereinafter referred to as the "agreement") to perform extensive consultations. At the meeting, the United States designated product management, unexpected adverse events processing issues full Exchange. National Council for the United States in the agreement shall specify which of the 10 products work situation is described, and the US representative provides registered above 10 kinds of product related information. US representative on the Chinese side the work of the early, and on the next stage of planning. The signing of the agreement, to build up the United States in the field of pharmaceutical and medical device regulation bridge of friendship and cooperation, on promoting the United States in the field of medical device regulatory cooperation has and will continue to play an important role. 8 months after November 19-20 June, the Joint Commission on Commerce and after the listing of medical device regulation and recall workshop was held in Beijing. The seminar by SFDA medical equipment Division and the United States Department of Commerce Office of health and consumer products, the two countries organized jointly by peers at the meeting on issues of mutual concern. The seminar, two extensive exchanges and probe, including international medical device adverse event reports, United States food and Drug Administration (FDA) regulatory practices, quality system and adverse event reporting, the medical devices regulatory Ordinance revision, medical devices and in vitro diagnostic reagents regulations implementation of the latest, training advice, etc. Meeting the greatest reward is, both sides expressed their future will further enhance cooperation in relevant areas, and a regular dialogue and GrooveFlux mechanism.

Apart from the United States such developed countries actively collaborate, also active in the management of the Affairs of medical devices in Asia.

Nov. 3-6, in New Delhi, India in the 13th Asian medical device regulatory coordination meeting (hereinafter referred to as AHWP, is a non-governmental organization that corresponds to the global organization of Asian institutions GHTF, existing members-17), elected by the delegates, SFDA medical Secretary Wang Ting was elected as the Asian medical device regulatory coordination Council for a term of three years. This is the first time as Chairman of the State of the organization. After 1 month, December 20, AHWP2008 year work planning meeting held in Shenzhen. From China, Korea, India, Malaysia, Singapore, Saudi Arabia, Chinese Taipei, Hong Kong and other countries and regions of more than 50 government officials and representatives of the economic members attended the meeting. The meeting focused on and determine the 2009-2011 work plan, including: developing member economies a comparative study of the regulatory system and annual summary; revised and timing AHWP vote; organization of Asian developing countries mission in 2009 medium-term to developed countries Australia visit medical equipment advanced supervisory experience, etc. The main objectives include: the establishment of medical device classification principles; trial registration review; in conditional all Member economies share adverse event and recall information; according to the guiding principles of the GHTF, drafting complete quality system requirements, system audit and clinical evaluation of guidance documents. Whether it's collaboration with the United States, or whether he was elected as the 13th Asian medical device regulatory coordination Council of the Presidency, as a developing country, China will strengthening international medical device regulations and regulatory coordination and communication play a positive role. In major events and sudden disaster, before the group security event, the use of medical devices and drugs is essential, therefore, a special period of the medical device security work is important, not only does it reflect a national system of quality guarantee mechanism, but a State of internal and external image. 2008 against snow and ice hazards, earthquake disaster, the Olympic Games is the experience of a few special period, but also to the Chinese medical device security capabilities of several major challenges. So, in a creative way, under the guidance of the new China medical device security mechanisms and mounting, and run well. May 12, Wenchuan after the earthquake, the timely provision of necessary medical equipment supply to disaster-stricken areas and the effective protection of their quality and safety become medical device regulatory agenda. For the timely processing of special cases, do not delay in response time, SFDA medical equipment Division in ensuring the quality and safety for medical devices, will be handling the special matter, in order to ensure the affected areas opens up with armed needs a "fast track": 5, 13 April morning, medical equipment Division research developed the support earthquake relief work in the medical device regulation related to the emergency notice "on the same day afternoon issued to Beijing, Tianjin, Hebei, Liaoning, Shanghai, Jiangsu, Zhejiang, Jiangxi, Shandong, Henan, Guangdong's 11 provinces; 15 may in the morning, medical equipment Division received Shenzhen's the robust industrial (Shenzhen) co., Ltd. donated to disaster relief health materials for emergency instructions, Secretary services, will be held immediately and respond the same day, agree with robust industrial (Shenzhen) co., Ltd. with reference to the National Council on strengthening the donation relief drugs and medical devices regulatory circular" donated overseas production of medical devices should be obtained the import of medical device product registration card, or has approved the listing of foreign government departments and quality product "of donations, and product packaging with Chinese description. As the disaster medical device quality and safety supervision departments to Sichuan province food and Drug Administration to start joint management mechanisms, Joint Health Department of Sichuan Province issued the use on the strengthening of disaster relief, medical supervision of guidance, medical institutions and medical goods receiving point as the focus of monitoring using links to promote medical institutions internal use management system especially acceptance, storage, conservation and use of registration management system as well as medical device adverse event and use security incident reporting system, improve and implement to ensure that disaster relief, medical use safe and effective. The success of the Beijing Olympic Games is the top priority for 2008. To ensure the quality and safety for medical devices during the Olympic Games, Olympic medical device inspection collaboration works came into being. 26 March, SFDA led, established the Beijing Olympic Games and Paralympics medical treatment apparatus quantity of the inspection work mechanism, developed the Beijing 2008 Olympic Games and Paralympics medical device quality collaborative work programme (hereinafter referred to as the "work programme"), a national medical equipment collaborative inspection work. In accordance with the requirements of the work programme, Beijing medical equipment quality supervision and inspection Center (hereinafter referred to as "Beijing Center") to become Olympic pre-race and race time medical device quality inspection (verification) of the main implementation units. When you receive the product in the Beijing Centre Chengjian outside, you need to review major inspection tasks or important product inspection results, the required verification of the product, the original registration test data, i.e. the launch of the national coordination mechanism for the medical device quality inspection, the Member of the collaboration of personnel, organization, communication, task, process, technology, providing support in terms of conditions. In order to test the Olympic medical device quality collaborative platform emergency collaboration capabilities, improve medical linkage inspection team of rapid response and cooperative engagement levels, June 2, 1830, Olympic medical device quality collaborative emergency drills in the Beijing Centre for Olympic medical treatment apparatus quantity of the collaborative work of emergency inspection of accumulated practical experience. As the Olympic host city, July 8, Beijing has also conducted a medical device recall walkthrough, walkthrough to assume that the two enterprises of Beijing city and parts of stent ventilator and security vulnerability discovered, medicines regulatory authorities ordered the enterprise recall as background, three stages. This combat exercises is the innovation of the Beijing Olympics security series of walkthroughs of Beijing for the first time around medical equipmentRecall of combat exercises. Much of this walkthrough in one fell swoop, both testing and exercise in Beijing city and district levels of drug regulatory authorities responding to medical emergencies to medical device regulatory staff to become more familiar with the supervision of the medical device recall organization methods, levels of specialization and focus, and testing and training the medical device manufacturing, management, and use unit medical device recall obligations. At the same time, the regulatory authorities fully grasp the current problems of the medical device recall, is the next perfect recall work offers a valuable experience. According to statistics, by running Olympic medical device inspection collaboration works, complete Olympic test task 85 batches, Olympic verification task 128 batch, which through collaboration platform completed test (verification) task 120 batches for Olympic medical treatment apparatus quantity of the security built solid lines. At present, the medical equipment Division is working on collaborative mechanisms in the operating conditions during the Olympic Games, to explore "seamless butt, deepen collaboration" mode, for medical device inspection service elements of reasonable configuration, making it not only serve the Olympic medical device safety and security, thus promoting the construction of the national joint medical examination coordination mechanism.