Medical equipment is what industry?

Question 1: What industry is the medical equipment company is operating, is a wholesale or retail in the wholesale and retail industry category.

See if there is a shop store, some are retail, no wholesale.

Question 2: Industry classification of national standards medical devices belong to what kind of industry Hello, the industry type of medical equipment belongs to the biomedical industry

Question 3: Medical equipment belongs to what kind of industry Hello, the industry type of medical equipment belongs to the biomedical industry

Question 4: The difference between the medical equipment industry and the pharmaceutical industry The pharmaceutical industry includes the medical equipment industry.

The main categories of the pharmaceutical industry include: chemical raw materials and preparations, Chinese herbal medicines, traditional Chinese medicine, Chinese medicine, proprietary Chinese medicines, antibiotics, biological products, biochemical drugs, radiopharmaceuticals, medical devices, sanitary materials, pharmaceutical machinery, pharmaceutical packaging materials and pharmaceutical business.

Question 5: What are the most promising prospects for the development of medical devices in the next 10 years? The development of medical devices will undergo a "qualitative change"

"Made in China 2025" proposes to improve the innovation capacity of medical devices and industrialization, focusing on the development of imaging equipment, medical robots and other high-performance diagnostic and therapeutic equipment, fully degradable The company is also working on the development of high-value medical consumables such as vascular stents and mobile medical products such as wearable and remote diagnosis and treatment. The company has also realized breakthroughs and applications of new technologies such as bio-3D printing and induced pluripotent stem cells.

Industry analysts point out that in recent years, China's medical device industry development results are gratifying, but from the overall development situation, focused on low-end products in the field of high-end products market has been foreign enterprises "domination".

It is expected that in the next 10 years, the development of China's medical device industry will usher in a sea change. The development of China's medical device industry will gradually shift from quantity and production to quality and brand, and the market pattern will undergo a fundamental change, with innovative companies with strong scientific research capabilities and strong brand influence being the mainstream of the market.

High-end medical equipment dawn in the future

Beijing, a medical equipment enterprise responsible for the reporter said, has been, China's medical equipment high-end market is almost monopolized by imported brands, while the proportion of exported products is higher in the middle and low-end market of domestic brands.

"Made in China 2025" clearly puts biomedicine and high-performance medical devices as one of the ten key areas of development, the introduction of this policy will further promote the support of the relevant departments of the development of high-performance medical devices, and at the same time greatly stimulate the innovation of medical device enterprises ***.

In addition, medical devices is the fastest growing industry in China in recent years, with an average annual growth rate of more than 20% for many years, much higher than the average growth level of the national economy.

China has become the world's third largest medical device market after the United States and Japan. However, high-tech medical equipment has been the 'short board' of China's medical device industry.

With great momentum, more and more "Made in China" products will appear in the domestic and international high-end medical device market in the future.

Question 6: What are the CFDA's standards for the medical device industry? CFDA attaches great importance to

Compared with the old and new ISO, there are several differences. 03 version of the "regulatory requirements" appeared 9 times, while the FDIS version appeared as high as 37 times; in the "Clause 3 Definitions", 03 version of the **** 8 definitions, this revision of the FDIS version of the definition, the FDIS version of the definition, the FDIS version of the revised. In the "Article 3 Definitions", there are 8 definitions in the 03 version***, and in the revised FDIS version, there are 14 new definitions including "Clinical Evaluation", and the previous 8 definitions have been revised and deleted to 4 and so on.

China's CFDA attaches great importance to the new version of the ISO, as early as the new version of the ISO release of the news after, before the vote, the State Food and Drug Administration Medical Device Standards Management Center has been held in Beijing, the new version of the ISO 13485 standard transformation workshop. This is the embodiment of the importance of ISO medical device certification.

ISO

13485 standard is an important standard in the field of medical devices, we should fully consider the harmonization of standards and regulations in our country, in-depth study of how to transform in China's regulatory situation, to enhance the enforceability of the standard; and at the same time, to strengthen the right to speak in the international standard development and revision of our country, and continue to enhance the status. This is for the future of China's medical device exports and enhance China's medical device in the international status and prestige to lay the foundation!

Three key aspects

Further clarification of the content of the medical device document

The medical device document can contain or refer to other documents to confirm compliance with standards and regulatory requirements. From the substantive content, the new version of the standard and GMP requirements of the content is not conflicting, basically match, but GMP requirements are more detailed and clear.

Design Development

With regard to the confirmation of design development, there are three ways in which a manufacturer's design is usually confirmed:

1. An analysis of the scientific literature relevant to the medical device being designed and developed

2. Historical evidence that demonstrates that similar designs and/or materials are clinically safe

3. Clinical investigations (trials). ).

Regardless of the approach, as required by the new version of the standard, a validation program should be established with clear guidelines for acceptance, including the determination of a statistically significant sample size. In this regard, and the current registration regulations are also more consistent. Representative samples should be selected for confirmation and a rationale statement for sample selection should be documented.

Where a connection to another medical device is anticipated, the confirmation should confirm that such a connection meets the requirements of the intended use. For example, if clinical trials are conducted, it is desirable to conduct clinical trials in conjunction with the medical device to which the connection is intended.

Design transitions

The old ISO 13485 standard did not have specific requirements for design transitions, and only included one sentence. The new version of the standard requires the establishment of procedural documentation of the design transition process to ensure that the design development output is validated before becoming a formal specification. The results and conclusions of the design changeover are retained. The new version of the standard requires the creation of program documentation for the design transition process to ensure that the design development output is validated before becoming a formal specification.

Which companies can apply for ISO?

1, medical device designers and manufacturers, such as: medical device design companies, medical device manufacturers;

2, medical device operators, such as: the wholesale and retail of medical devices, medical device export trading companies, etc.;

3, medical device service providers, such as: disposable device irradiation sterilization station, ethylene oxide EO sterilization. Ethylene Oxide EO sterilization company, medical device installation companies; medical device transportation or equipment maintenance;

4, medical device hardware and software and parts/materials suppliers such as: active device PCB board suppliers, gauze weaving factory, ultrasound machine power cord, medical software companies.

Question 7: What is the medical equipment sales industry? It belongs to the medical industry麽

Question 8: What is the current situation of China's medical device industry and what are the challenges it faces? China's medical device industry from small to large, rapid development, has become a relatively complete product categories, increasing innovation capacity, market demand is very strong sunrise industry. Especially in recent years, the development of medical device industry further accelerated for many years, the output value to maintain double-digit growth, the number of products exported and the content of science and technology is also constantly improving.

First, the development of China's medical device industry

1, the overall development

Foresight Industry Research Institute released the "2016-2021 China's medical industry brand competition and investment opportunity analysis report" pointed out that in 2014 China's medical device industry **** realized sales revenue of 213.607 billion yuan, an increase of 13.1%; The total industrial output value also amounted to 217.591 billion yuan, a year-on-year increase of 12.1%. From the point of view of the growth rate of the total output value of medical devices and pharmaceutical industry in recent years, the development speed of medical devices is generally faster than the pharmaceutical industry.

2, product structure

From the product structure of China's medical device market in the past three years, diagnostic imaging equipment occupies the largest market share, in recent years have remained at about 40%, and is a rising trend; followed by various types of consumables, occupying about 20% of the market; orthopaedic and implantable medical equipment market share is declining; the remaining market share is occupied by the dental and other types of devices occupied.

3, the competitive structure

In China's medical equipment accounted for 25% of the market for high-end products, 70% of the foreign occupation, in most areas of foreign-funded enterprises in technology and quality far ahead of domestic enterprises, especially medical imaging equipment and in vitro diagnostics and other areas of high technical barriers, market share of more than 80%. Domestic enterprises in the middle and low-end market have natural advantages: such as lower production costs brought about by the price advantage, enjoy the relative tilt of national policy, the advantages of localized channel mastery, etc. Therefore, mainly occupy the middle and low-end market of China's medical device industry, some subsectors appear leading enterprises, mainly concentrated in the field of higher value-added products. And in the low-end consumables and black and white ultrasound and other low-end medical equipment field manufacturers, product differentiation is low, industry concentration is low.

4, the overall summary

China's medical device industry development foundation is weak, medical device regulation started late, the phenomenon of small, many, scattered and low-level competition of medical device enterprises has not yet been a fundamental transformation, accelerate to improve the technical innovation ability of China's medical device industry, and strengthen the pharmaceutical device R & D of the joint production, research and development of the research, has become a pressing task.

Moreover, from the point of view of China's medical device market, high-end products are mainly dependent on imports. Although there are more than 2,000 export certified enterprises in China, most of them are relatively weak in terms of scale, brand competitiveness, and lack of core technology, foreign exports can only be based on OEM, the lack of their own brand, the competition in the international market is generally in a disadvantageous position.

It is gratifying that some of the leading enterprises in China's niche areas are striving to break through to the high-end market. For example, the largest domestic R & D team, the strongest comprehensive development capabilities of the Myriad has been in the domestic market share of high-end monitors up to 49%, five-classification hemocytometer, full automation and color ultrasound and other core products of some of the independent innovation technology has reached the world's advanced level. And high-end consumables products leading Shandong Weigao is also through the cooperation with Medtronic to improve technology and brand, penetrate the high-end market.

With the accelerated transfer of international industry, China will become an important production base for global medical equipment, part of the original reliance on imported instruments and equipment is gradually realized to replace the import of domestic. At the same time, many provinces and cities in China have taken the medical device industry as a new economic growth point, and have been cultivating it. Overall, China's medical device industry is entering a phase of rapid development.

Second, the development of China's medical equipment industry, the main features

Because of China's large consumer groups and *** active support, China's medical equipment market development space is broad, the development of the industry presents the following development characteristics.

1, the situation of small and medium-sized enterprises has not changed

China's medical device industry, although after more than a decade of rapid development, but the situation of small and medium-sized enterprises in the industry has not yet changed, low, small, scattered is one of the important characteristics of China's medical device industry, the development of the industry is also dependent on the production of technology to continue to innovate and develop. There are tens of thousands of medical device enterprises in China. As of the end of 2013, there were 995 enterprises above the scale of China's medical device industry, of which less than 2% were large-sized enterprises, more than 170 were medium-sized enterprises, more than 700 were small-sized enterprises, and the enterprises below the scale of the industry were countless. At present, small and medium-sized enterprises are the medical equipment industry in terms of sales scale and asset scale. ...... >>