Business Club December 9th, 2009 In response to the increase in market entry standards for medical insurance products in the international market, the Medical Insurance Association has successively developed a "Guide to Quality Control for the Export of Infusion Pumps/Syringe Pumps" and other product quality guidelines for export.
The complexity of the international economic situation, the uncertainty of international demand, and the increasingly pressing trade protectionism are forcing China’s health insurance export commodities to face a “breakthroughâ€.
“The complexity of the current international trade situation has gradually become normal. In the future, we will introduce relevant quality control guidelines for various categories of medical insurance export commodities from time to time to provide reference for enterprises.†China Import and Export Business Association for Pharmaceuticals and Health Products (hereinafter referred to as The Secretary-General of the Medical Insurance Association, Cui Bin, disclosed to the “Medicine Economics†reporter that on the basis of “structuring and transferring modesâ€, in order to further improve the export quality of medical insurance products, the Ministry of Commerce ordered the Medical Insurance Association to follow the “Guidelines for the Export Quality Control of Health Productsâ€. After the compilation of the Guidelines for the Export of Disposable Syringes and the Guidelines for the Quality Control of Export of Infusion Pumps/Syringe Pumps, we have responded to the difficult problems that have arisen in China's health insurance export enterprises.
FDA raises the bar
The reporter recently learned that the FDA is currently planning to increase the market entry rate for external infusion pumps/injection pumps, which will have a major impact on the export of such commodities to the US market.
"Beginning in April of this year, the US FDA has publicly solicited opinions on the submission of guidelines for submitting information on applications for pre-marketing Infusion Pump/injection pump [510(K)]. Once this document is finalized, it will replace the one issued by FDA in March 1993. "Guidance on submission of information content for external infusion pump/Syringe Pump [510(K)] applications will be widely evaluated for all external infusion pumps/syringe pumps intended for sale in the US market to ensure the availability of such products. After the issue of safety." Wang Cong, deputy secretary-general of the Medicare Chamber of Medical Devices, told reporters.
It is understood that the development and application of infusion pump medical device products in foreign countries has a history of nearly half a century, and the use of infusion pumps is very common in Western countries. At present, infusion pumps used in foreign countries can be roughly divided into in vitro infusion pumps and implantable infusion pumps from infusion methods, of which the market volume of external infusion pump products is the largest. According to Frost & Sullivan Consulting, currently there are approximately 50 million patients around the world who need to use infusion pumps for infusions. The world's infusion pump market has annual sales of up to US$83 billion.
Although our medical institutions rarely use infusion pumps in clinical practice, with the rapid development of China's economy and the increased investment in medical and health care by the national and local governments, the clinical application of infusion pumps/syringe pumps has been in the past 10 years. Has gained explosive growth. According to statistics, by 2010, China's medical institutions have equipped more than 200,000 infusion pumps/syringe pumps with an average annual growth rate of more than 35%. According to the analysis made by relevant experts in 2008, from the perspective of market prospects, although the US population is only about 300 million, the annual demand for infusion pumps in the medical market is several times that of the infusion pumps in China. Therefore, the infusion pump/injection The rapid growth of the pump market will continue for a long time to come. After 10 years, the total installed capacity of infusion pumps/syringe pumps in China will exceed 1 million units.
Compared with US hospitals or clinics, the use of infusion pumps is very common. For the Chinese medical market, infusion pumps and syringe pumps are still a new industry and have only been in development for nearly 10 years. At the same time, domestic infusion pumps are basically imitation of foreign technology, even if the manufacturers have independent intellectual property rights, but also only slightly changed in appearance, there is no major technical update. With the expansion of the market demand for infusion pumps/syringe pumps and the capacity expansion of related products, the quality control of infusion pumps/syringe pumps is also increasingly stringent.
According to Wang Cong, the quality standards for infusion pumps/syringe pumps are increasingly stricter internationally. Referring to the report received indirectly from the FDA's FDA Center for Devices and Radiological Health (CDRH) from 2005 to 2009, the FDA received more than 56,000 medical device adverse event reports related to the use of infusion pumps, including 710 patients, in five years. Death is related to problems with infusion pump medical devices.
The FDA analysis shows that the equipment problem seems to be caused by an imperfect design. Of these reports, about 1% report deaths, 34% report severe injuries, and 62% report failures. The FDA believes that the actual death data may be much higher. Some of these deaths involve overdose. This occurs because of hospital staff's input of incorrect dose data to the infusion pump, and because of infusion pump software. A malfunction has occurred.
Countermeasures
According to FDA regulations, life-sustaining medical devices, such as cardiac defibrillators, usually undergo clinical trials before they are allowed to be sold. However, the FDA did not initially approve the sale of many other important medical devices (such as infusion pumps/syringe pumps) based on the results of intellectual property tests. It was based on the “new devices and some kind of The product is similar to the statement.
In response to the above issues, the FDA has issued preliminary instructions to require medical device manufacturers that produce infusion pumps/syringe pumps to provide FDA with more test data before they can obtain sales authorization. According to the new proposal, the manufacturer will be required to provide additional data. In addition, manufacturers must also conduct limited clinical trials to ensure that the infusion pumps/syringe pumps they produce are not misused or that there are no design elements that can cause errors.
“At present, at least in the US market, the FDA has increased the level of risk assessment for infusion pump/injection pump products, and correspondingly increased the time required for the product to obtain a sales license and the time required for approval. I believe regulators in other countries will also The US FDA's practice has strengthened the supervision and listing approval of infusion pump products.†Wang Cong believes that this requires that manufacturers of infusion pump/syringe pump products in China must make relevant preparations when exporting products. Fully compliant evidence materials should be aligned with the conditions for improvement. Therefore, the Ministry of Commerce’s Foreign Trade Department and the Medical Insurance Association organized relevant professionals to collect, collate and compile the “Guidance on the Quality Control of Medical Infusion Pumps/Syringe Pump Exports†as a medical insurance. Foreign trade companies have better access to regulations, standards, and conformity assessment procedures for access to the international market, stride across technical barriers to trade, improve the independent innovation capability of medical infusion pumps/syringe pumps in China, increase the quality of export product management, and expand medical infusion pumps in China. Syringe pump products provide reference for export.
"Pharmaceutical products are related to people's lives and health. Countries around the world, especially European and American countries, have implemented strict technical and administrative supervision in areas related to their R&D, production, and sales. Our enterprises are facing increasingly severe barriers to entry into the international market." Xu Ming, director of the General Affairs Department of the Chamber of Commerce, said that despite the apparent progress in China’s foreign trade during the “Eleventh Five-Year Plan†period, there are still many development challenges that need to be resolved.
According to Cui Bin, the guidelines for the export of plant extracts in the category of Chinese herbal medicines are expected to be released by the end of this year. In the future, the Joint Ministry of Commerce will jointly launch a quality control guide for the export of medical insurance related products, which will also become a long-term work of the Chamber of Commerce.
The complexity of the international economic situation, the uncertainty of international demand, and the increasingly pressing trade protectionism are forcing China’s health insurance export commodities to face a “breakthroughâ€.
“The complexity of the current international trade situation has gradually become normal. In the future, we will introduce relevant quality control guidelines for various categories of medical insurance export commodities from time to time to provide reference for enterprises.†China Import and Export Business Association for Pharmaceuticals and Health Products (hereinafter referred to as The Secretary-General of the Medical Insurance Association, Cui Bin, disclosed to the “Medicine Economics†reporter that on the basis of “structuring and transferring modesâ€, in order to further improve the export quality of medical insurance products, the Ministry of Commerce ordered the Medical Insurance Association to follow the “Guidelines for the Export Quality Control of Health Productsâ€. After the compilation of the Guidelines for the Export of Disposable Syringes and the Guidelines for the Quality Control of Export of Infusion Pumps/Syringe Pumps, we have responded to the difficult problems that have arisen in China's health insurance export enterprises.
FDA raises the bar
The reporter recently learned that the FDA is currently planning to increase the market entry rate for external infusion pumps/injection pumps, which will have a major impact on the export of such commodities to the US market.
"Beginning in April of this year, the US FDA has publicly solicited opinions on the submission of guidelines for submitting information on applications for pre-marketing Infusion Pump/injection pump [510(K)]. Once this document is finalized, it will replace the one issued by FDA in March 1993. "Guidance on submission of information content for external infusion pump/Syringe Pump [510(K)] applications will be widely evaluated for all external infusion pumps/syringe pumps intended for sale in the US market to ensure the availability of such products. After the issue of safety." Wang Cong, deputy secretary-general of the Medicare Chamber of Medical Devices, told reporters.
It is understood that the development and application of infusion pump medical device products in foreign countries has a history of nearly half a century, and the use of infusion pumps is very common in Western countries. At present, infusion pumps used in foreign countries can be roughly divided into in vitro infusion pumps and implantable infusion pumps from infusion methods, of which the market volume of external infusion pump products is the largest. According to Frost & Sullivan Consulting, currently there are approximately 50 million patients around the world who need to use infusion pumps for infusions. The world's infusion pump market has annual sales of up to US$83 billion.
Although our medical institutions rarely use infusion pumps in clinical practice, with the rapid development of China's economy and the increased investment in medical and health care by the national and local governments, the clinical application of infusion pumps/syringe pumps has been in the past 10 years. Has gained explosive growth. According to statistics, by 2010, China's medical institutions have equipped more than 200,000 infusion pumps/syringe pumps with an average annual growth rate of more than 35%. According to the analysis made by relevant experts in 2008, from the perspective of market prospects, although the US population is only about 300 million, the annual demand for infusion pumps in the medical market is several times that of the infusion pumps in China. Therefore, the infusion pump/injection The rapid growth of the pump market will continue for a long time to come. After 10 years, the total installed capacity of infusion pumps/syringe pumps in China will exceed 1 million units.
Compared with US hospitals or clinics, the use of infusion pumps is very common. For the Chinese medical market, infusion pumps and syringe pumps are still a new industry and have only been in development for nearly 10 years. At the same time, domestic infusion pumps are basically imitation of foreign technology, even if the manufacturers have independent intellectual property rights, but also only slightly changed in appearance, there is no major technical update. With the expansion of the market demand for infusion pumps/syringe pumps and the capacity expansion of related products, the quality control of infusion pumps/syringe pumps is also increasingly stringent.
According to Wang Cong, the quality standards for infusion pumps/syringe pumps are increasingly stricter internationally. Referring to the report received indirectly from the FDA's FDA Center for Devices and Radiological Health (CDRH) from 2005 to 2009, the FDA received more than 56,000 medical device adverse event reports related to the use of infusion pumps, including 710 patients, in five years. Death is related to problems with infusion pump medical devices.
The FDA analysis shows that the equipment problem seems to be caused by an imperfect design. Of these reports, about 1% report deaths, 34% report severe injuries, and 62% report failures. The FDA believes that the actual death data may be much higher. Some of these deaths involve overdose. This occurs because of hospital staff's input of incorrect dose data to the infusion pump, and because of infusion pump software. A malfunction has occurred.
Countermeasures
According to FDA regulations, life-sustaining medical devices, such as cardiac defibrillators, usually undergo clinical trials before they are allowed to be sold. However, the FDA did not initially approve the sale of many other important medical devices (such as infusion pumps/syringe pumps) based on the results of intellectual property tests. It was based on the “new devices and some kind of The product is similar to the statement.
In response to the above issues, the FDA has issued preliminary instructions to require medical device manufacturers that produce infusion pumps/syringe pumps to provide FDA with more test data before they can obtain sales authorization. According to the new proposal, the manufacturer will be required to provide additional data. In addition, manufacturers must also conduct limited clinical trials to ensure that the infusion pumps/syringe pumps they produce are not misused or that there are no design elements that can cause errors.
“At present, at least in the US market, the FDA has increased the level of risk assessment for infusion pump/injection pump products, and correspondingly increased the time required for the product to obtain a sales license and the time required for approval. I believe regulators in other countries will also The US FDA's practice has strengthened the supervision and listing approval of infusion pump products.†Wang Cong believes that this requires that manufacturers of infusion pump/syringe pump products in China must make relevant preparations when exporting products. Fully compliant evidence materials should be aligned with the conditions for improvement. Therefore, the Ministry of Commerce’s Foreign Trade Department and the Medical Insurance Association organized relevant professionals to collect, collate and compile the “Guidance on the Quality Control of Medical Infusion Pumps/Syringe Pump Exports†as a medical insurance. Foreign trade companies have better access to regulations, standards, and conformity assessment procedures for access to the international market, stride across technical barriers to trade, improve the independent innovation capability of medical infusion pumps/syringe pumps in China, increase the quality of export product management, and expand medical infusion pumps in China. Syringe pump products provide reference for export.
"Pharmaceutical products are related to people's lives and health. Countries around the world, especially European and American countries, have implemented strict technical and administrative supervision in areas related to their R&D, production, and sales. Our enterprises are facing increasingly severe barriers to entry into the international market." Xu Ming, director of the General Affairs Department of the Chamber of Commerce, said that despite the apparent progress in China’s foreign trade during the “Eleventh Five-Year Plan†period, there are still many development challenges that need to be resolved.
According to Cui Bin, the guidelines for the export of plant extracts in the category of Chinese herbal medicines are expected to be released by the end of this year. In the future, the Joint Ministry of Commerce will jointly launch a quality control guide for the export of medical insurance related products, which will also become a long-term work of the Chamber of Commerce.
Our Liquid Handling Products is good in quality and competitive in price. We are manufacturer and supplier Liquid Handling Products following your specific requirement. We are looking forward to your E-mail and establishing cooperative relationship with you! We would provide professional Liquid Handling with good services for you!
Liquid Handling
Eppendorf Pipette Tips, Gilson Pipette Tips, Filter Pipette Tips, Dispensing Pipette
Ningbo Cland Medical Instruments Co., Ltd. , https://www.ruipumedical.com