Business Community April 29 hearing precisely because Yixie industry optimistic about China's development potential and the momentum of export growth, multinational companies are increasing Yixie testing in China input. With the increase in recent years, the standard domestic Yixie work forward, the future of technology services from technology upgrade in competition emerge.
Strong demand for testing services
April 2, SGS-CSTC Standards Technical Services Co., Ltd. (hereinafter referred to as SGS) of Ministry of active service medical equipment medical equipment laboratory opening ceremony was held in Guangzhou. Laboratory was established to integrate and enhance medical device testing services SGS capacity for domestic enterprises to enter international markets Yixie green channel to create one-stop shop to help businesses and medical device products in the international market competition.
SGS Group, the Port Director of Medical Services, said Guan Chun Chao, the newly established Department of Medical Services SGS Life Science Services integration, international certification services, light industrial products and services and medical equipment services to all aspects of active resources, most land to enhance the medical device product testing service capabilities, and Hong Kong region for medical appliance manufacturers to provide a more optimized, more convenient service.
In the eyes of multinational companies Yixie testing with China's medical equipment exports to 30% per year growth rate, foreign companies began to high-end medical equipment in China to invest heavily in product research, can be predicted that China's medical device industry will flourish.
Guan Chun Chao said, SGS Medical Services Division and the establishment of an active medical device laboratory, will be a comprehensive analysis of their own status and medical device product management and market conditions, and provide one-stop solutions to help customers solve, including medical device products design, production, packaging, marketing, products exported to international markets during the various technical problems or confusion.
Meanwhile, another multinational Yixie TUV SÜD also increased efforts to promote efforts, the group medical director of Health Services Greater China, Miss Chen Zhaohui, said: "In recent years, the European Union on imported medical devices have become increasingly demanding of certification body with the professional resources also put forward higher requirements. "
Showing posts with label medical product. Show all posts
Showing posts with label medical product. Show all posts
2011/05/01
Optimistic comment on China's high-end medical equipment market
2011 ChinaVenture China Investment in China in the 28 Ritz-Carl Shanghai Pudong Hotel. Infinity Private Equity Fund Group's managing partner, said high-Zhe-ming, and now the momentum of business growth in China is very good, he said: "We have 25% to 35% of the medical aspects of the investment, mainly for high-grade , A sharp medical devices, and we are very concerned about intellectual property investment. "
It is reported that Infinity different from other short-term market based purely financial investors exit, the positioning of Infinity is a technology-oriented strategic investors. High Zhe Ming said: "In China, whether pharmaceutical companies or medical device companies, which we are all very interesting. So the key factor, not only in the growth of this market, we can add value. "
Short-term return on investment as the current investors in a trend. "Everyone is playing the game, this is not a problem, which of course is a new security approach, but there are many factors that restrict their access to short-term benefits, including regulatory policy and so on. " In fact, the long-term flickering light Companies should be those value-oriented real business.
Zhe-ming in high opinion, to earn quick money in other particularly important to maintain long-term value. "patience will pay off. sometimes, some investors may not understand your industry, or some private equity will cause some problems, but in emerging markets that happens is very normal, competition is a Good test device. "
It is reported that Infinity different from other short-term market based purely financial investors exit, the positioning of Infinity is a technology-oriented strategic investors. High Zhe Ming said: "In China, whether pharmaceutical companies or medical device companies, which we are all very interesting. So the key factor, not only in the growth of this market, we can add value. "
Short-term return on investment as the current investors in a trend. "Everyone is playing the game, this is not a problem, which of course is a new security approach, but there are many factors that restrict their access to short-term benefits, including regulatory policy and so on. " In fact, the long-term flickering light Companies should be those value-oriented real business.
Zhe-ming in high opinion, to earn quick money in other particularly important to maintain long-term value. "patience will pay off. sometimes, some investors may not understand your industry, or some private equity will cause some problems, but in emerging markets that happens is very normal, competition is a Good test device. "
National medical device into the high-end market
WASHINGTON national medical device companies are seeking solutions to improve independent innovation capability and competitiveness of high-end market. April 23, the leading medical device companies in China Shandong Weigao Group to join hands with the Chinese Academy of Sciences, released a first batch of high-tech research plans to support the project, the project report had reached 122, which received funding support of Item 8 of the plan, involving polymer materials, blood purification materials, high-tech products such as orthopedic materials. Guide its second research project, the main R & D interests include medical materials, medical supplies, medical equipment and high-tech bio-medicine and other fields, will develop a high level of prices generous diagnosis treatment and products.
China Medical Device Industry Association statistics show that China's medical device manufacturers around 3000, but most small business scale, market power is limited, and in addition to individual enterprises, most are generic high-end medical equipment, improve the Lord, ECG, CT, MRI and other medical devices basically can not see the high-end domestic brands, multinational corporations monopoly over 80% domestic market share. In the ultrasound equipment, magnetic resonance imaging equipment, and other fields, the monopoly of multinational companies share even more than 90%. China Medical Device Industry Association, former vice president of Xerox Cheng said: "This is an absolute monopoly in fact, the result is high prices, but also aggravated the people 'doctor of your' problem."
Weigao Group has worked with Chinese Academy of Sciences DICP cooperation to break the monopoly of the German company, developed a recombinant protein immunoadsorption column, mainly used for dialysis or organ transplant rejection generated. Former domestic cost of each dialysis hemodialysis patients need more than 400 yuan, the annual average per patient more than 60,000 yuan; Viagra realize the localization of high costs can be reduced after each dialysis nearly 50%; China's 200 million people have kidney disease, Gateway products such as the use of high treatment, kidney dialysis each year for the country to save more than 600 million patients.
Accordance with the "Chinese Academy of Sciences - Granville High Group high-tech Research and Development Program" Framework for the development of arrangements for R & D each year 30 million yuan, of which Weigao Group invested 15 million yuan funds, representatives of the Office of Science and Technology of Shandong Province, Shandong Province invested 500 million CAS invested 500 million, Weihai municipal government invested 500 million in basic research, applied research and development, trial production, innovation platform, information and personnel exchanges, so as to carry out comprehensive cooperation.
China Medical Device Industry Association statistics show that China's medical device manufacturers around 3000, but most small business scale, market power is limited, and in addition to individual enterprises, most are generic high-end medical equipment, improve the Lord, ECG, CT, MRI and other medical devices basically can not see the high-end domestic brands, multinational corporations monopoly over 80% domestic market share. In the ultrasound equipment, magnetic resonance imaging equipment, and other fields, the monopoly of multinational companies share even more than 90%. China Medical Device Industry Association, former vice president of Xerox Cheng said: "This is an absolute monopoly in fact, the result is high prices, but also aggravated the people 'doctor of your' problem."
Weigao Group has worked with Chinese Academy of Sciences DICP cooperation to break the monopoly of the German company, developed a recombinant protein immunoadsorption column, mainly used for dialysis or organ transplant rejection generated. Former domestic cost of each dialysis hemodialysis patients need more than 400 yuan, the annual average per patient more than 60,000 yuan; Viagra realize the localization of high costs can be reduced after each dialysis nearly 50%; China's 200 million people have kidney disease, Gateway products such as the use of high treatment, kidney dialysis each year for the country to save more than 600 million patients.
Accordance with the "Chinese Academy of Sciences - Granville High Group high-tech Research and Development Program" Framework for the development of arrangements for R & D each year 30 million yuan, of which Weigao Group invested 15 million yuan funds, representatives of the Office of Science and Technology of Shandong Province, Shandong Province invested 500 million CAS invested 500 million, Weihai municipal government invested 500 million in basic research, applied research and development, trial production, innovation platform, information and personnel exchanges, so as to carry out comprehensive cooperation.
Question about x-ray scattering line
Medical equipment bed unit / bedside machine X-ray scattering line is how the protection? Keywords: medical device category of medical devices medical device companies in China Network
C-arm X-ray machine X-ray machine prices X-ray machine X-ray machine maintenance pet hand X-ray machine X-ray machine maintenance principles of medical X-ray machine X-ray machine dental X-ray machine X-ray machine prices
Categories Medical Devices Medical Devices Medical device company in China SHANGHAI, classification of medical devices medical equipment medical equipment medical equipment sales network forum Oriental Medical Devices
Ray machines commonly used bedside lead protective curtain, according to the different doses of radiation machine, you need to choose a different lead equivalent lead curtain, on infants and young children, pregnant women and couples planning a pregnancy should put an end to irradiation.
C-arm X-ray machine X-ray machine prices X-ray machine X-ray machine maintenance pet hand X-ray machine X-ray machine maintenance principles of medical X-ray machine X-ray machine dental X-ray machine X-ray machine prices
Categories Medical Devices Medical Devices Medical device company in China SHANGHAI, classification of medical devices medical equipment medical equipment medical equipment sales network forum Oriental Medical Devices
Ray machines commonly used bedside lead protective curtain, according to the different doses of radiation machine, you need to choose a different lead equivalent lead curtain, on infants and young children, pregnant women and couples planning a pregnancy should put an end to irradiation.
Glass cutting head is in the medical device category types?
Glass cutting head is in the medical device category types?
Are three types of sterile medical devices implanted in the class!
On the website of the Medicines for imported equipment, enter the name of the "glass cutting head ", the search results after 2008 are in accordance with the approved products listed three types of management, in the category 6822
Reference: State Food and Drug Administration data query
Are three types of sterile medical devices implanted in the class!
On the website of the Medicines for imported equipment, enter the name of the "glass cutting head ", the search results after 2008 are in accordance with the approved products listed three types of management, in the category 6822
Reference: State Food and Drug Administration data query
What's Medical device products in the category management category 123?
Medical device products in the category management category 123 category What do you mean, respectively,
Medical device classification rules
The first category to regulate medical devices, according to "Supervision and Regulation of Medical Devices", the enactment of this rule.
The second refers to medical devices: the human body alone or in combination with instruments, equipment, apparatus, material or other
Items, including the necessary software. Purpose of use is:
(A) disease prevention, diagnosis, treatment, monitoring or mitigation.
(B) injury or disability of the diagnosis, treatment, monitoring, mitigation or compensation.
(C) of the anatomical or physiological process of investigation, replacement or adjustment.
(D) of pregnancy control.
For the human body by its not the role of pharmacology, immunology or metabolic means, but it may have this
Some means to participate and play a supporting role.
Article III of the Rules for guidance, "medical device category," the formulation and identification of new product registration category.
Classification of medical devices as defined in Article IV, should be based on structural characteristics of medical devices, medical equipment and medical devices used in the form
Mechanical status of the three aspects of the use of a comprehensive decision.
Determine the specific medical devices can be classified according to "medical device classification decision table" (see annex).
Article Criteria of Medical Device Classification
(A) structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active and passive medical equipment medical equipment.
(B) the form of medical devices
Depending on the intended purpose, the use of medical devices classified as a certain form. Of which:
1. Passive devices use forms: liquid transportation saving devices; change in the blood, body fluids equipment; medical dressings; outside
Science instruments; re-use surgical instruments; disposable sterile instruments; implants; contraception and family planning devices; disinfection clear
Cleaning equipment; care devices, in vitro diagnostic reagents, and other passive devices such as auxiliary contact or passive.
2. Active devices use the form: energy treatment equipment; diagnostic monitoring equipment; transmission fluid device; ionizing radiation
Instruments; laboratory equipment, medical sterilization equipment; other active devices or active auxiliary equipment.
(C) the state of medical devices
According to the use of the possibility of damage to the human body, the effects of medical, medical device usage can be divided into
Contact or enter the human body equipment and non-contact equipment, concrete can be divided into:
1. Contact or enter the body Devices
(1) the use of time is divided into: temporary use; short-term use; long-term use.
(2) into contact with human body parts: skin, or cavity; trauma or body tissue; the blood circulation system or central nervous system
System.
(3) active devices out of control into the extent of damage: minor injuries; injury; serious injury.
2. Non-contact body devices
Effect on the medical, which were divided into: Basic does not affect; have indirect effects; have a major impact.
Implementation of Article VI to determine the principles of classification of medical devices
(A) the implementation of the classification of medical devices should be determined according to the classification table.
(B) Classification of medical devices according to their intended use to determine the main purpose and role. If you use the same product objective
And different mode of action, classification should be determined separately.
(C) medical devices used in conjunction with other medical devices should be classified separately; attachment classification of medical devices
Its support of the host should be separated from the case of a separate category in the Annex.
(D) role in several parts of the human body for medical devices, according to the use of high-risk form, the use of state classification.
(E) control function of medical device software and the medical devices are classified according to the same class.
(F) If a medical device can be applied to two categories, should be taken to the highest classification.
(Vii) monitor or main function of medical device products, and its classification of devices being monitored and classification.
(H) The State Drug Administration of the work requires, in need of special supervision and management of medical devices can be adjusted
The entire classification.
Article VII of the competent State Drug Administration medical device classification. Basis of "medical devices category" not
Can determine the classification of medical devices, by the provincial drug administration department under the "Medical Device Classification Rules" pre-sub-
Class, and report to the State Drug Administration approval.
Article VIII of the Rules the following terms mean:
(A) of the intended objectives: refers to the product description, label or promotional materials enumerated, the use of medical devices should be made
Use.
(B) Risk: the risk of injury caused by the occurrence of human possibility and severity of the injury.
(C) the use of period:
1. Temporary: the continuous use of equipment is expected within 24 hours of time;
2. Short-term: equipment expected within 24 hours of continuous use over time within 30 days;
3. Long-term: the continuous use of equipment is expected to more than 30 days;
4. Continuous use of time: the purpose of equipment as expected, there is no interruption to the actual role of the time.
(D) the use of parts and equipment:
1. Non-contact devices: No direct or indirect contact with the device;
2. Surface contact devices: including parts in contact with the following equipment:
(1) skin: only contact with the skin surface of the device is not damaged;
(2) mucous membranes: mucous membrane contact with the device;
(3) damage the surface: surface wound or other injury in contact with equipment.
3. Invasive surgical instruments: With surgery, instruments penetrated all or part of the body through the surface, the contact includes the following
Parts of the equipment:
(1) vascular: invasive vascular and blood on the road a point of contact; as a pipeline to the vascular system, the input device;
(2) Organizational / bone / dentine: invasive tissue, bone and pulp / dentin system, equipment and materials;
(3) blood circulation: contact with the blood circulation system equipment.
(E) implants: Any use of surgery, all or part of the access device or natural cavity in the body; in
After the surgical procedure to stay in the body, or parts of these devices remain in the body at least 30 days or more, these devices are considered
As is the implants.
(F) Active devices: any electric or other energy dependent and not directly by the energy produced by the human body or gravity to send
Play the function of medical equipment.
(G) re-use surgical instruments: refers to equipment used in surgery to cut, cut, drill, saw, grasping, scraping, clamping,
Pumping, folder, or a similar surgical procedure, not connected to any active devices, the processing by certain devices can be re-used.
(Viii) central circulatory system: refers to the human blood circulation in the pulmonary artery, aorta, coronary, carotid, cerebral
Arteries, cardiac veins, the large vena cava, inferior vena cava large.
(Ix) the central nervous system: refers to the brain, meninges, spinal cord.
Medical device classification rules
The first category to regulate medical devices, according to "Supervision and Regulation of Medical Devices", the enactment of this rule.
The second refers to medical devices: the human body alone or in combination with instruments, equipment, apparatus, material or other
Items, including the necessary software. Purpose of use is:
(A) disease prevention, diagnosis, treatment, monitoring or mitigation.
(B) injury or disability of the diagnosis, treatment, monitoring, mitigation or compensation.
(C) of the anatomical or physiological process of investigation, replacement or adjustment.
(D) of pregnancy control.
For the human body by its not the role of pharmacology, immunology or metabolic means, but it may have this
Some means to participate and play a supporting role.
Article III of the Rules for guidance, "medical device category," the formulation and identification of new product registration category.
Classification of medical devices as defined in Article IV, should be based on structural characteristics of medical devices, medical equipment and medical devices used in the form
Mechanical status of the three aspects of the use of a comprehensive decision.
Determine the specific medical devices can be classified according to "medical device classification decision table" (see annex).
Article Criteria of Medical Device Classification
(A) structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active and passive medical equipment medical equipment.
(B) the form of medical devices
Depending on the intended purpose, the use of medical devices classified as a certain form. Of which:
1. Passive devices use forms: liquid transportation saving devices; change in the blood, body fluids equipment; medical dressings; outside
Science instruments; re-use surgical instruments; disposable sterile instruments; implants; contraception and family planning devices; disinfection clear
Cleaning equipment; care devices, in vitro diagnostic reagents, and other passive devices such as auxiliary contact or passive.
2. Active devices use the form: energy treatment equipment; diagnostic monitoring equipment; transmission fluid device; ionizing radiation
Instruments; laboratory equipment, medical sterilization equipment; other active devices or active auxiliary equipment.
(C) the state of medical devices
According to the use of the possibility of damage to the human body, the effects of medical, medical device usage can be divided into
Contact or enter the human body equipment and non-contact equipment, concrete can be divided into:
1. Contact or enter the body Devices
(1) the use of time is divided into: temporary use; short-term use; long-term use.
(2) into contact with human body parts: skin, or cavity; trauma or body tissue; the blood circulation system or central nervous system
System.
(3) active devices out of control into the extent of damage: minor injuries; injury; serious injury.
2. Non-contact body devices
Effect on the medical, which were divided into: Basic does not affect; have indirect effects; have a major impact.
Implementation of Article VI to determine the principles of classification of medical devices
(A) the implementation of the classification of medical devices should be determined according to the classification table.
(B) Classification of medical devices according to their intended use to determine the main purpose and role. If you use the same product objective
And different mode of action, classification should be determined separately.
(C) medical devices used in conjunction with other medical devices should be classified separately; attachment classification of medical devices
Its support of the host should be separated from the case of a separate category in the Annex.
(D) role in several parts of the human body for medical devices, according to the use of high-risk form, the use of state classification.
(E) control function of medical device software and the medical devices are classified according to the same class.
(F) If a medical device can be applied to two categories, should be taken to the highest classification.
(Vii) monitor or main function of medical device products, and its classification of devices being monitored and classification.
(H) The State Drug Administration of the work requires, in need of special supervision and management of medical devices can be adjusted
The entire classification.
Article VII of the competent State Drug Administration medical device classification. Basis of "medical devices category" not
Can determine the classification of medical devices, by the provincial drug administration department under the "Medical Device Classification Rules" pre-sub-
Class, and report to the State Drug Administration approval.
Article VIII of the Rules the following terms mean:
(A) of the intended objectives: refers to the product description, label or promotional materials enumerated, the use of medical devices should be made
Use.
(B) Risk: the risk of injury caused by the occurrence of human possibility and severity of the injury.
(C) the use of period:
1. Temporary: the continuous use of equipment is expected within 24 hours of time;
2. Short-term: equipment expected within 24 hours of continuous use over time within 30 days;
3. Long-term: the continuous use of equipment is expected to more than 30 days;
4. Continuous use of time: the purpose of equipment as expected, there is no interruption to the actual role of the time.
(D) the use of parts and equipment:
1. Non-contact devices: No direct or indirect contact with the device;
2. Surface contact devices: including parts in contact with the following equipment:
(1) skin: only contact with the skin surface of the device is not damaged;
(2) mucous membranes: mucous membrane contact with the device;
(3) damage the surface: surface wound or other injury in contact with equipment.
3. Invasive surgical instruments: With surgery, instruments penetrated all or part of the body through the surface, the contact includes the following
Parts of the equipment:
(1) vascular: invasive vascular and blood on the road a point of contact; as a pipeline to the vascular system, the input device;
(2) Organizational / bone / dentine: invasive tissue, bone and pulp / dentin system, equipment and materials;
(3) blood circulation: contact with the blood circulation system equipment.
(E) implants: Any use of surgery, all or part of the access device or natural cavity in the body; in
After the surgical procedure to stay in the body, or parts of these devices remain in the body at least 30 days or more, these devices are considered
As is the implants.
(F) Active devices: any electric or other energy dependent and not directly by the energy produced by the human body or gravity to send
Play the function of medical equipment.
(G) re-use surgical instruments: refers to equipment used in surgery to cut, cut, drill, saw, grasping, scraping, clamping,
Pumping, folder, or a similar surgical procedure, not connected to any active devices, the processing by certain devices can be re-used.
(Viii) central circulatory system: refers to the human blood circulation in the pulmonary artery, aorta, coronary, carotid, cerebral
Arteries, cardiac veins, the large vena cava, inferior vena cava large.
(Ix) the central nervous system: refers to the brain, meninges, spinal cord.
Whether imports of equipment based medical device classification categories?
I now want to apply for the import agent chemiluminescence apparatus medical equipment production license, does this instrument imported and domestic division of whether the instrument, are based on "Medical Device Category " and classify Ⅰ, Ⅱ, Ⅲ Class, thank you! Please help!
Provide customs clearance of imports tax package freight service.
If you have the goods to be imported back, as long as you arrange shipping to my warehouse to Hong Kong to help you through our tax package customs clearance of imports over procedure is simple, fast and convenient customs clearance, you can save a reasonable high Customs value-added tax, reducing the cost of imports, the import process as long as the freight on it, I Division is specialized in Hong Kong (foreign) tax package to the mainland customs clearance of imports and freight services, hoping to provide import services for you, if looking for me, Please add my nickname
Not the same
Classification is yes, but all imported equipment of the registration certificate (not a production license) by the State Food and Drug Administration review process.
Does the product is produced in the country for it?
If it is in domestic production, foreign manufacturers of brand affixed in accordance with domestic regulatory instruments, the need for manufacturers license, product registration card in the declaration, in accordance with the domestic medical equipment category classification.
If the imported products, but also need to follow the requirements of the directory category by product category, the State Food and Drug Administration to declare up.
Problems in the production license only for the domestic production of equipment are required.
"Imports of medical equipment production license", without this thing. State Food and Drug Administration issued the import certificate of registration of medical devices, according to the audit made three types of standards. chemiluminescence instruments are two types of medical devices in China. ISO13485 approved more To the more difficult
Provide customs clearance of imports tax package freight service.
If you have the goods to be imported back, as long as you arrange shipping to my warehouse to Hong Kong to help you through our tax package customs clearance of imports over procedure is simple, fast and convenient customs clearance, you can save a reasonable high Customs value-added tax, reducing the cost of imports, the import process as long as the freight on it, I Division is specialized in Hong Kong (foreign) tax package to the mainland customs clearance of imports and freight services, hoping to provide import services for you, if looking for me, Please add my nickname
Not the same
Classification is yes, but all imported equipment of the registration certificate (not a production license) by the State Food and Drug Administration review process.
Does the product is produced in the country for it?
If it is in domestic production, foreign manufacturers of brand affixed in accordance with domestic regulatory instruments, the need for manufacturers license, product registration card in the declaration, in accordance with the domestic medical equipment category classification.
If the imported products, but also need to follow the requirements of the directory category by product category, the State Food and Drug Administration to declare up.
Problems in the production license only for the domestic production of equipment are required.
"Imports of medical equipment production license", without this thing. State Food and Drug Administration issued the import certificate of registration of medical devices, according to the audit made three types of standards. chemiluminescence instruments are two types of medical devices in China. ISO13485 approved more To the more difficult
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