In the global medical technology and biomedical maps, China is not the most productive drug, but the Chinese medicine, and the medical equipment that spontaneously forms certain advantages.
Every year, at the large and medium-sized medical equipment exhibitions held around the world, there are many Chinese people everywhere. Although there is still a big gap between China and the world in many high-end products, this gap has become smaller and smaller with the rise of private medical device companies such as Shenzhen Mindray and Yuyue Medical. Medical equipment is undoubtedly one of the most internationalized areas in China's medical technology and biomedical industries.
In the domestic market, medical devices are also in the market integration stage after crazy growth, repeated construction, and vicious competition. Many enterprises lacking in technical content have been eliminated by the market. The strength of scale and technology has made the strong stronger.
In the face of the huge Chinese market, high-end multinational foreign-funded medical device companies are in any way reluctant to watch local competitors grow stronger. After a lack of competition strategy, they can only "eliminate" their opponents through acquisition.
A strong upstream must make an extraordinary downstream. With its unique model, the Retail Terminal Rehabilitation Home has grown into the best medical device retail terminal under the new business model in China in a short period of time, and is constantly strategically deployed nationwide.
A complete medical device industry chain that integrates various formats, models and features has been continuously improved. At the moment, it has also ushered in an industry-intensive “promotion periodâ€, and the industrial adjustment efforts have been further strengthened, and the future left to the strengths is certainly broader.
During this critical period, the China Pharmaceutical Materials Association officially launched the establishment of a medical device branch after a long period of preparation. After a thorough and extensive industry research, the club edited and published the "2013 China Medical Device Industry Development Status".
This report is mainly composed of six parts: industry macro policy, development summary, main features, existing problems, global development overview, and forecasting of future trends. It strives to comprehensively analyze, refine and observe the development of the industry from various angles for the industry peers. reference.
Chapter 1 Impact of China's Medical Device Policy on the Market in 2013
In 2013, China introduced fewer medical device policies, but some of the policies were revised to have certain impact on the market. At the same time, including the follow-up effects of industry policies before 2013, as well as macro-policies such as the new medical reform and the State Council's support for health services, it also has a corresponding impact on the medical device industry.
I. Amend the Regulations on the Supervision and Administration of Medical Devices, focusing on three major changes.
The current Regulations on the Supervision and Administration of Medical Devices have not been revised since the first edition was issued in 2000. Some provisions are unreasonable and restrict the development of the medical device industry. The contents of the new version of the regulations include the relaxation of registration review, the establishment of a green channel for review, adjustment of product registration and production site licensing order.
In 2007, the former State Food and Drug Administration issued the draft for the first time the draft of the revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Revised Draftâ€); in 2010, the Legislative Affairs Office of the State Council took the lead in revisiting the draft for the society. In the past two years, the revised draft has repeatedly sought comments on a small scale, but they have all stopped.
The reason why the amendments to the regulations are "suspended" is closely related to the long-term management of medical devices. However, after the adjustment of the state institutions in 2013, the State Administration of Quality Supervision has cancelled the certification function for imported medical devices, so the new regulations can be successfully revised.
The main content of the current regulations revolves around how medical device companies obtain permission from the regulatory authorities. Due to the early promulgation, many issues were not involved, leading to many problems in implementation. The new regulations will adjust the product registration and production site licensing order changes, from the need to first apply for a production license after the registration of products can be first registered and then apply for production license. This means that medical device companies can focus on product development and listing without having to spend upfront resources on production plant investment, which will greatly ease the financing pressure of SMEs and help innovation.
In addition, the new regulations have also accelerated the progress of registration review of medical devices. For example, the green channel for review is added. The above-mentioned insiders indicated that the three types of high-risk medical devices are the main targets for green channels. At present, most high-value consumables on the market belong to three types of medical devices, and the green channel will speed up product upgrading. At the same time, some of the three types of medical devices will be reclassified into the second category, and the regulatory pressure has eased.
Second, after the implementation of the "High-value medical supplies centralized procurement work specification", the price effect is reflected in the market
At the end of 2012, the former Ministry of Health issued the “Regulations on the Centralized Purchasing of High-value Medical Consumablesâ€, which clearly explored the implementation of provincial-level centralized bidding for high-value medical consumables such as vascular intervention, and proposed “promoting quantity procurement and volume price similar to drug bidding. The requirements of the linked purchase and sale model.
From a national perspective, centralized procurement of medical consumables at the provincial level is being widely spread. Since last year, about ten provincial-level administrative units have started unified bidding for medical consumables. The average price reduction for the first round of medical high-value consumables in Zhejiang Province and Henan Province, which was first implemented, reached 15% and 25% respectively.
Behind the provincial-level centralized bidding, the government’s intention to directly control the price of medical devices is highlighted. In addition to the bidding department, the National Development and Reform Commission is also preparing to master and clean up the sales price of medical devices. As early as 2011, relevant departments have issued a draft of the "Interim Measures for the Price Management of Medical Devices for Interventional Devices", but due to strong reaction from the industry. Shelved.
In July this year, when the leaders of the Price Department of the National Development and Reform Commission discussed the medical service charges and the price management of medical devices, they again proposed to strengthen the supervision of the price of medical consumables, strictly control the individual types of charges, and the price control has been on the line.
Third, four ministries and commissions "medical equipment special support" policy
At the beginning of the year, the Ministry of Industry and Information Technology has begun to work out a work plan to accelerate the development of the medical device industry, mainly for some guiding ideas, focusing on the long-term development of the industry, but it has not been introduced until the end of October.
On July 17, Deputy Director Wu Haidong of the Consumer Products Industry Department of the Ministry of Industry and Information Technology said that the special medical equipment category is the key point of support for the new implementation this year. It clearly proposes to promote the industrialization of new products and the application of new technologies in the medical device field. The key support objects include mastering core components. And medical equipment such as key technologies.
In fact, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance and the Health Planning Commission are working together to formulate a special project for industrial revitalization and technological transformation. The total special support fund is 1.5 billion yuan. Among them, the development of high-performance medical diagnosis and treatment equipment in 2013 will focus on medical imaging equipment and other fields to achieve coordinated development of the upstream and downstream of the industrial chain. The three major areas of support include medical imaging equipment, in vitro diagnostic products, and therapeutic equipment .
Enterprises that are included in the special project are expected to receive a generous subsidy “red envelope†– support funds of more than 10 million yuan. Since July, the rumors have begun to rumor that the Ministry of Industry and Information Technology will soon announce the list of companies that have been included in the special project, but until the beginning of November, the list has not yet been launched.
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