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New regulations for medical device supervision and administration will be released

2019-07-22

During the China Pharmaceutical Innovation Development Conference, Jiao Hong, director of the National Medical Products Administration, stated: "We will actively promote the release of the newly revised "Drug Administration Law" and "Medical Device Supervision and Administration Regulations" within the year, accelerate the revision of supporting regulations, provide legal and regulatory safeguards for the early implementation of various reform measures, and release policy dividends." The China Pharmaceutical Innovation Development Conference recently opened in Jinan, with Jiao Hong, director of the National Medical Products Administration, in attendance and giving a speech. Jiao Hong pointed out that after 40 years of reform and opening up, China's public drug use has been basically met, the level of drug security has continued to improve, and China has actively contributed to the world. Currently, domestic medical

The National Health Commission continues to issue documents supporting the accelerated entry of domestic medical equipment into hospitals!

2019-07-19

The National Health Commission has issued consecutive documents in support of the comprehensive promotion of the priority use of domestically produced medical equipment in the medical industry! The Ningxia Hui Autonomous Region Health Commission's official website published the "Notice of the Autonomous Region Health and Health Commission Office on Further Regulating the Procurement of Imported Medical Equipment and Reagents and Consumables". This Notice is the first document issued by the Health Commission since the beginning of this year regarding the strict restriction of imported medical equipment! The Notice clearly states that government procurement should procure domestic products; for those that require the procurement of imported products, an examination and approval system will be implemented! In terms of the review of the "Government Procurement of Imported Products Expert Review Opinion Form" issued by the expert group, the Notice specifies the qualifications of the experts

Analysis of the Current State of China's Medical Device Industry

2019-07-18

China's medical device manufacturing enterprises have grown from a few hundred at the beginning of the reform and opening up to nearly 15,343 in 2016; the total output value of the medical device industry has increased from negligible at the beginning of the reform and opening up to nearly 5,000 billion yuan in 2016. Today, China has become one of the world's major producers and consumers of medical devices. The Current Status of China's Medical Device Industry China's medical device manufacturing enterprises have grown from a few hundred at the beginning of the reform and opening up to nearly 15,343 in 2016; the total output value of the medical device industry has increased from negligible at the beginning of the reform and opening up to nearly 5

Analysis and expert interpretation of the latest progress in the special approval of innovative medical devices in China

2019-07-17

Foreword: The "Special Approval Procedures for Innovative Medical Devices (Trial)", released on February 7, 2014, and effective from March 1, 2014, stipulates a special approval channel for medical devices with Chinese invention patents, possessing domestically pioneering and internationally leading technology, and exhibiting significant clinical application value. Since the implementation of the "Special Approval Procedures for Innovative Medical Devices (Trial)", China has accelerated the market launch of innovative medical devices with high technological content and urgent clinical needs, while simultaneously expediting the import substitution of high-end medical devices. Current Status of Innovative Medical Device Approvals The "Innovative Medical Devices...

Promoting and training POC ultrasound technology. Hospitals and enterprises are constantly striving forward.

2019-07-16

Anesthetics, needles, and anesthesia machines are used in various ways to ensure patients feel no pain during surgery. Many view the work of anesthesiologists as monotonous. In reality, alleviating pain associated with surgical trauma represents only a small fraction of their duties. Most of their time is dedicated to regulating essential life functions and protecting vital organs. With the application of visualization technologies such as ultrasound imaging, particularly point-of-care ultrasound (POC), in the field of anesthesia, anesthesiologists can, on one hand, improve the effectiveness and safety of regional anesthesia through ultrasound-guided precise nerve blocks, reducing the proportion of general anesthesia or the amount of opioid analgesics used, thus lowering anesthesia risks and promoting postoperative recovery. On the other hand, anesthesiologists use ultrasound technology to make more accurate assessments of patients' vital organ function during the perioperative period, improving the efficiency of diagnosis and treatment of critical conditions that threaten patients' lives, and more effectively monitoring and regulating basic life functions and protecting and supporting vital organs. In short, the widespread application of POC technology in anesthesiology has enhanced the clinical skills of anesthesiologists, improved the medical service capabilities of the anesthesiology discipline, and promoted the development of anesthesiology and surgery. Promoting POC ultrasound technology helps improve diagnosis and treatment. "A person's basic life functions include respiration, heart rate, pulse, blood pressure, internal environment, and neurological function. Due to surgical risks, anesthesia risks, and the health hazards posed by the patient's own surgical diseases and comorbidities, the main work of anesthesiologists now involves monitoring and regulating the patient's basic life functions, protecting and supporting vital organs, and ensuring the patient's life safety during the perioperative period." This was stated in an interview by Liu Jin, director of the Anesthesiology Department at Huaxi Hospital of Sichuan University, during the 2019 Huaxi Perioperative Medicine International Academic Week and the 10th Huaxi Visualization Technology Application Conference in Anesthesia, Analgesia and Critical Emergency Rescue. Liu Jin, director of the Anesthesiology Department at Huaxi Hospital of Sichuan University, further stated, "Before the advent of visualization technology, because the respiratory system, circulatory system, nervous system, and other human systems are located inside the human body, physicians could only observe the surface with the naked eye during monitoring and treatment. This led to blindness in the operation and diagnosis of these systems. POC ultrasound technology helps physicians overcome the limitations of the naked eye's inability to see through the body, allowing them to see the human systems within the body cavity and observe changes in the system's status in a timely manner. Additionally, during anesthesia procedures, the position of the needle tip and tube tip can also be monitored for accuracy, achieving 'seeing is believing'. Therefore, the application of POC ultrasound and other visualization technologies has significantly improved medical quality and brought great benefits to patients." In explaining the significance of the emergence of ultrasound technology, Liu Jin further pointed out that another advantage of POC ultrasound technology is its portability. Ultrasound instruments can be moved to the patient's side for examination as needed by the clinician, making them particularly suitable for departments such as anesthesiology, ICU, and emergency departments where patients are not easily moved. "The strategic significance of the current widespread adoption of POC ultrasound technology in clinical departments such as anesthesiology is similar to the adoption of stethoscopes by medical personnel 120 years ago or bedside electrocardiograms 60 years ago, raising the level of clinical diagnosis and treatment to a new level." In Liu Jin's view, this modern technology, after further integration with intelligence and big data in the future, will see further improvements. "In the future, the department that skillfully masters POC ultrasound technology will be the one that develops best." Liu Jin said with great certainty. "The application of POC ultrasound in anesthesiology mainly focuses on ultrasound-guided vascular puncture, nerve blocks, and intraoperative transesophageal echocardiography (TEE). This is different from the ultrasound performed by the ultrasound department for patients; those departments use ultrasound for disease diagnosis." This was added by Zuo Yunxia, deputy director of the Anesthesiology Department at Huaxi Hospital of Sichuan University. She also provided a detailed explanation of the application of POC ultrasound in anesthesiology. For example, ultrasound-guided central venous puncture can accurately locate the position and depth of the blood vessels, distinguish ectopic blood vessel courses, avoid mispuncturing arteries and damaging the pleura and lung tissue, improve the success rate on the first attempt, and reduce puncture complications. The hospital is taking action in providing POC ultrasound training. According to Zuo Yunxia, currently, every heart surgery at Huaxi Hospital involves transesophageal ultrasound performed by anesthesiologists. This is because transesophageal ultrasound examination avoids interference from the surgical area and lung tissue, allowing the probe to be closer to the heart. By observing the function of each chamber and valve of the heart before and after surgery, it helps to assess the surgical outcome and guides anesthesiologists in regulating circulatory function. This effectively improves the safety and success rate of heart surgery. Since 2009, Huaxi Hospital's Anesthesiology Department has been hosting the Huaxi Visualization Technology Application Conference in Anesthesia, Analgesia and Critical Emergency Rescue. Overcoming various difficulties in the promotion process, they have been committed to promotion work. Zuo Yunxia, deputy director of the Anesthesiology Department at Huaxi Hospital of Sichuan University, stated, "In addition to the laboratory and radiology departments, the ultrasound department plays a role in auxiliary diagnosis. Ultrasound technology is the most widely used in disease diagnosis, and it is indispensable for internal medicine, surgery, obstetrics and gynecology, and pediatrics. Currently, various clinical departments mainly rely on the examination reports of the ultrasound department. If clinical specialists can master POC technology and move the ultrasound machine to outpatient diagnostic rooms and wards, it will undoubtedly improve the medical service quality and efficiency of many clinical specialties. After all, the sensitivity and accuracy of ultrasound probes in disease diagnosis surpass the clinician's sense of touch and stethoscope." She also pointed out that to enable more clinicians, particularly perioperative physicians in anesthesiology, emergency, and critical care medicine, to master ultrasound technology, Huaxi Hospital uses the visualization conference and ultrasound technology training courses to disseminate basic ultrasound technologies and skills to clinicians and focuses on training key ultrasound techniques to address perioperative clinical issues. Since 2009, more than 5,000 anesthesiologists, pain management specialists, emergency physicians, and ICU physicians from across the country have participated in the visualization conference, over 2,000 have participated in Huaxi Hospital's three-day ultrasound technology training courses, and over 200 have participated in the three-month transesophageal ultrasound technology training courses. Currently, these trained physicians have not only applied their knowledge clinically after returning to their respective hospitals but have also spread the knowledge by conducting similar training courses, cultivating more perioperative clinicians who master POC technology. As China's first anesthesiologist to perform transesophageal ultrasound, Liu Jin believes that the training courses are only at the primary stage. "Currently, we need to conduct large-scale, centralized, and standardized training based on the current foundation. As the first chairman of the Ultrasound Group of the Chinese Medical Association's Anesthesiology Branch, during the handover with the current chairman, we divided the application of ultrasound in anesthesia into three parts: transesophageal ultrasound, body surface ultrasound monitoring and evaluation, and ultrasound-guided nerve blocks and arteriovenous puncture cannulation. Three-month standardized training outlines were developed for each part. Now that the outlines have been issued, the training at Huaxi Hospital strictly follows the outlines." "Physicians can learn each section as needed or complete all three parts in nine months. Although the learning time is long, I hope that after systematic learning, trainees will spend another three months conducting some ultrasound-related clinical research, which will make the acquired skills more solid." Liu Jin hopes that in the national promotion process, anesthesiologists learning ultrasound in the future will receive training according to the outline's requirements and skillfully serve patients. In addition, regarding the current controversy in China about the necessity of anesthesiologists mastering ultrasound technology, Zuo Yunxia hopes that relevant departments will provide support, establish corresponding mechanisms, and issue corresponding qualification certificates to trained physicians to prove their qualifications. The entire industry is working to popularize POC ultrasound equipment and technology. At the Huaxi Visualization Conference training courses, physician trainees from across the country listened attentively and meticulously, recording the lectures with their phones. One trainee stated, "Through the teacher's explanation, many problems encountered in daily practice were answered one by one. Moreover, under the teacher's guidance and demonstration, the technique of manipulating the probe was also corrected." Trainees attentively listening to the teacher's lecture. According to Zuo Yunxia, training courses are a "required course" for every physician attending the visualization conference. "Early training courses required hiring experts from the United States, which was expensive. This problem was solved after cooperating with ultrasound imaging technology companies. Manufacturers are not obligated to participate in training. However, the participation of companies not only solved the equipment problem but also solved the training funding problem to a certain extent." Regarding China's existing ultrasound equipment and technology, Liu Jin pointed out, "In recent years, the development of ultrasound equipment has been very rapid. Currently in China, equipment manufacturers have their own advantages and disadvantages. When purchasing equipment, hospitals should consider the specific model and manufacturer based on the current needs of the department. Overall, domestic equipment is developing rapidly and can meet the clinical needs of most anesthesiologists, and the price is also relatively reasonable. Of course, compared with some brands from developed countries, although domestic equipment lags slightly in some aspects, some companies, including Mindray, are making efforts and progressing rapidly." While affirming national ultrasound brands, Liu Jin also made higher demands on companies. Taking single-plane ultrasound esophageal probes as an example, he hopes that China's ultrasound equipment companies can cooperate with clinicians to strive for overtaking on a curve and be at the forefront of the world. Due to the rapid development of ultrasound imaging technology in recent years, more and more companies are dedicated to promoting the clinical application of ultrasound imaging equipment and technology. According to Shan Juan, Mindray's POC ultrasound manager in China, in China's ultrasound imaging equipment market, domestic ultrasound brands represented by Mindray have not only replaced imported brands in the mid-to-low-end product market but are also seizing the high-end market. "Mindray entered the ultrasound field in 1996, and after integrating global R&D resources, has successively launched Resona 7 high-end ultrasound systems, M9 portable ultrasound systems, and TE7 industry-first touch ultrasound systems, all of which have received positive feedback from ultrasound physicians." When discussing the current status of ultrasound imaging technology development in China and the overall industry perspective, Shan Juan stated, "With the development of ultrasound imaging technology, Mindray POC ultrasound now covers a full range of models from desktop ultrasound systems to highly integrated portable color ultrasound equipment. As a national brand, we not only strive to meet the needs of Chinese clinicians, but also have a responsibility to work with clinicians to promote the development of ultrasound imaging technology and overall medical levels in China. Since entering the medical imaging field, we have hired professional imaging physicians to provide product installation training, pre-sales usage training, and pre-sales demonstrations for various hospitals. In the future, we are willing to continue cooperating with qualified medical colleges or hospitals to contribute our modest efforts to popularizing ultrasound equipment and promoting POC ultrasound technology." (Dong Tong)

How do high-end medical device companies provide low-cost after-sale service?

2019-07-15

Unbearably high maintenance costs? I once wrote an article exploring the after-sale service costs of low-priced DRs. That article mentioned a government procurement project in Guizhou Province, where a DR was awarded for less than 250,000 yuan. However, according to my calculations, the annual maintenance cost of a DR could easily exceed 20,000 yuan. In other words, the annual warranty cost of a DR accounts for 8% of the purchase price. While an annual maintenance fee of 8% of the total equipment cost is a common proportion, it is still considered unbearable by many hospitals, especially small hospitals. In order to save

The United States will exempt 110 types of Chinese imported goods, including medical equipment and electronic components, from high tariffs.

2019-07-10

Summary: According to the Ministry of Commerce website, the US government said on Tuesday that it would exempt 110 Chinese products, ranging from medical devices to critical capacitors, from high tariffs, bringing relief to some US companies that had said the tariffs hurt their profits. Some of Tesla's Chinese-made car circuits did not receive an exemption. Reuters, Washington, July 9 - The US government said on Tuesday that it would exempt 110 Chinese products, ranging from medical devices to critical capacitors, from high tariffs, bringing relief to some US companies that had said the tariffs hurt their profits. On July 6, 2018, in the first round of the bilateral trade war, the US ...
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