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Leaders from the device registration department of the State Food and drug administration came to Beijing to investigate the management of clinical trials of medical devices

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Leaders from the device registration department of the State Food and drug administration came to Beijing to investigate the management of clinical trials of medical devices

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Leaders from the device registration department of the State Food and drug administration came to Beijing to investigate the management of clinical trials of medical devices

On August 2, 2019, Du Huiqin, deputy director of the Department of medical device registration and management of the State Drug Administration, led a team to Beijing for investigation and discussion with representatives of Beijing Municipal Drug Administration, some medical institutions and manufacturers, listened to the report on the development of clinical trials of medical devices in Beijing, and discussed the revised contents of the quality management standard for clinical trials of medical devices.
Wang Fuyi, member of the party leading group and deputy director of Beijing Municipal Drug Administration, attended the forum and introduced the filing of medical device clinical trial projects and institutions in Beijing in 2019, as well as the supervision and spot check of clinical trials. The participants mainly focused on the content of "quality management standard for clinical trials of medical devices", combined with the difficulties and problems in the process of clinical trials of medical devices, put forward opinions and suggestions.
Deputy director Du Huiqin fully affirmed the management of clinical trials of medical devices in our city and emphasized: first, we should carry out research on clinical trials supervision, scientifically use supervision data, and provide technical support for registration review and approval; second, we should establish the sense of responsibility of enterprises, strengthen their own clinical management ability, and strengthen the management of clinical trial partners; third, we should strengthen the management of clinical trial partners The key point is to investigate and deal with the authenticity of clinical trials.

Previous : Nevro, a medical device manufacturer（ NVRO.US ）Q2 revenue fell 3% year on year and net loss expanded to $28.02 million
Next : The 82nd China Medical Devices International Fair
Previous : Nevro, a medical device manufacturer（ NVRO.US ）Q2 revenue fell 3% year on year and net loss expanded to $28.02 million
Next : The 82nd China Medical Devices International Fair

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Medical device industry: implementation of high value consumables reform plan and improvement of industry standard 2020-12-09
1、 Clear policy direction and time limit for completion Recently, the general office of the State Council issued the reform plan for the management of high value medical consumables. In the next 1-2 years, it will straighten out the price system of high value medical consumables, improve the whole process supervision and management of high value medical consumables, purify the market environment and medical service practice environment of high value medical consumables, and constantly regulate the high value medical consumables industry. The document focuses on improving the price formation mechanism and reducing the false high price of high-value medical consumables, including unifying the coding system and information platform, implementing the medical insurance access and dynamic adjustment of the catalog, improving the classified centralized procurement method, canceling the medical consumables bonus, and formulating the medical insurance payment policy. According to the policy plan, by the end of 2019, the first batch of key governance lists will be completed, centralized procurement of high-value medical consumables will be started, and the mark up of medical consumables will be cancelled. In 2020, the classification and coding of high-value medical consumables in national medical insurance will be formulated and unified, the price monitoring and centralized procurement management platform of high-value medical consumables will be established, the basic medical insurance access system of high-value medical consumables will be established, and the circulation management will be strengthened And so on. 2、 Consumables price is the trend, independent innovation can maintain the competitiveness of the company's products We believe that for high-value medical consumables, price reduction is the general trend, in line with the policy direction. Centralized procurement is a game among hospitals, product providers, distributors and distributors. The core point is still the product itself. If the product is highly standardized, with small differences and lack of innovation, it will face greater pressure of price reduction. However, for the distribution oriented enterprises, on the one hand, the distributors are the firewall of price reduction and bear the brunt of price reduction On the other hand, through R & D and innovation, enterprises can achieve product upgrading iteration, new and old alternation, seek new pricing for innovative products, and maintain the company's overall gross profit rate and net profit rate, which is also the direction of policy support. For new technology products, accelerate the registration and approval, and timely add them into the medical insurance catalog. Therefore, the price reduction of high-value medical consumables has a relatively small and moderate short-term impact on the manufacturers, and encourages more innovative enterprises. It is suggested to pay attention to enterprises with independent innovation products: Lepu medical, minimally invasive medical, etc. 3、 IVD does not fall within the scope of this policy IVD and medical imaging equipment belong to the cost of hospital, which is highly market-oriented and does not belong to the scope of the policy. Medical devices include high-value medical consumables, IVD, medical imaging equipment, etc. this policy refers to high-value medical consumables, excluding IVD and medical imaging equipment. IVD and medical imaging equipment belong to hospital cost, which is different from the charging mode of high-value consumables. Medical service charges, while medical insurance pays for medical service price, not directly for consumables price. The purchase of IVD and medical imaging equipment is not directly related to medical insurance, which is based on the needs of hospital departments, financial allocation and hospital income. It is suggested to pay attention to the enterprises that are less disturbed by the policy: Antu biological, aide biological, Mindray medical, Mike biological, Wanfu biological, etc.
The medical device industry of economic development zone gets on the fast train 2020-12-09
Recently, it was learned from the Municipal Drug Administration that the quality system verification time of innovative medical devices has been shortened from 30 working days to 6 working days. This is another major good news for accelerating the approval speed of innovative medical devices after the State Food and Drug Administration issued the special approval procedure for innovative medical devices. As the "Jingnan pharmaceutical Valley", Beijing Economic and Technological Development Zone will focus on promoting the approval and listing of innovative medical device R & D enterprises, and accelerate the improvement of medical device industry layout with innovative medical device R & D and production enterprises as the traction. Shorten the examination and approval process Speed up product launch "Medical devices should be submitted first, and the drug regulatory department should conduct preliminary examination, inspection and testing, quality system verification, production condition verification, production license issuance, and enterprise production and marketing," said the relevant person in charge of the Economic Development Zone Branch of the food and drug administration. This is the approval process for medical device enterprises to obtain the registration certificate and production license, and in the approval process, it is found that most of the medical devices R & D enterprises are not good at quality system construction, and often spend a lot of time in quality system verification. The quality system verification time of innovative medical devices in the city is shortened from 30 working days to 6 working days, which will greatly improve the speed of the whole approval process. To speed up the verification of the quality system of medical device registration and approval is the result of the implementation of the "service package" system of key enterprises and the overall simplification and optimization of the service process of product review and approval by the drug regulatory department in accordance with the requirements of the "action plan for further optimizing the business environment in Beijing (2018-2020)". For the headquarters of domestic and multinational pharmaceutical enterprises with high-end R & D and production capacity, the Municipal Drug regulatory department appointed leading cadres as "service housekeeper" and "attendant" to investigate and solve the actual difficulties of enterprises from the base construction, industrial development, product promotion, project financing, talent introduction and other aspects, and coordinate multi department integration of land planning, R & D investment, drug approval, financial industry To provide on-site information, policies and services for enterprises through policies and measures on work, project acceptance, public rental housing for talents, enrollment of employees' children, payment of talents rental subsidies, etc. In order to encourage pharmaceutical enterprises to develop and innovate drugs and medical devices with national and global influence, the Municipal Drug Administration Department creatively establishes and improves the "service package" system according to the characteristics of product registration and listing. The implementation of a special person responsible for one thing, one discussion, accurate docking, full guidance. Comprehensively reduce the time limit for review and approval, quality verification, product inspection and licensing, open up a green channel for the registration of innovative drugs and medical devices, and concentrate professional and technical forces to provide high-quality consulting services for enterprises. Under such precise service, the time for quality system verification of innovative drugs and medical devices in the city has been shortened from 30 working days to 6 working days, and the inspection time limit before product registration has been shortened by more than one third. The food and Drug Administration Economic Development Zone Branch is a pioneer in practicing the "Butler" service of medical device product review and approval. Under the implementation of the "service package" system in the economic and Technological Development Zone, the food and drug administration economic and Technological Development Zone Branch regularly held "quality system construction training meetings" for the key link of "quality system verification" in the approval of medical devices, to guide medical device R & D enterprises to build quality system in advance and prepare for product approval. The staff who supervise the R & D and production of medical device enterprises have also been transformed into the "intimate housekeeper" who guides the approval and listing of medical devices. In the process of supervision, they can understand the problems faced by enterprises, guide enterprises deeply, and solve problems for enterprises. In order to make the medical device ente
FDA approved the first class II medical device software! Oleena helps cancer patients achieve self-management 2020-12-09
Founded in 2001 and headquartered in Paris, volunts is a medical software development company. The company is committed to developing digital medical technology to improve the quality of medical services and reduce medical costs. Volunts was listed on the pan European stock exchange in May 2018 with the stock code vtx. Recently, volunts announced that its digital medical software oleena has been approved by FDA. The digital tool can help cancer patients achieve self-management. Voluntis has developed oleena based on its proprietary digital tumor treatment platform teraxiom oncology, aiming to provide services for cancer patients undergoing radiotherapy and chemotherapy, tumor immunotherapy and tumor targeted therapy by combining patient self-management and telemedicine monitoring. Oleena is the first FDA approved class II software-as-a-medical device, which can be used for a variety of cancer indications. The software can record the clinical symptoms and progress of patients in real time, and provide self-management suggestions for patients with diarrhea, pain, nausea and vomiting and other side effects of cancer treatment. At the same time, oleena also feeds back the recorded data to medical institutions, so that doctors can carry out remote monitoring and disease analysis. The software can provide patients with timely and efficient medical information to help them adjust the treatment plan. Voluntis leadership believes that helping patients achieve self-management can reduce the occurrence of unexpected situations such as treatment interruption and help improve the overall treatment effect of patients. Oleena, a treatment tool based on communication technology, enables patients to control the complicated symptoms during treatment, so as to play an active role in self-management. At the same time, the remote monitoring technology of digital medical tools will also help clinicians reduce the burden. In addition, volunts has developed other digital medical tools that can be used for remote monitoring of diabetes, such as insulia and diabeo, to help patients better control their symptoms and provide users with insulin dosage recommendations. "In addition to monitoring patients' symptoms, we believe that digital and personalized treatment can also help patients improve their condition in a timely manner and save costs for clinical medical services," said Pierre leurent, chief executive of voluntis. We are very happy to introduce oleena to cancer patients. This innovative oncology digital medical software will completely change the traditional cancer treatment methods. " Dr. Arvind dasari, an oncologist at UT MD Anderson Cancer Center of the University of Texas, said: "voluntis digital therapy based on oleena software can help patients realize self-management and actively intervene in patients' condition through simple language and system. This is undoubtedly an important milestone in the field of cancer treatment. "  
Nevro, a medical device manufacturer（ NVRO.US ）Q2 revenue fell 3% year on year and net loss expanded to $28.02 million 2020-12-09
Zhitong financial app learned that after the U.S. stock market closed on Thursday, nevro Corp., a medical device company（ NVRO.US ）According to the financial results of the second quarter of 2019, the revenue was 93.6 million US dollars, which exceeded the market expectation, but decreased by 3% year on year; the net loss was 28.02 million US dollars, or 0.91 US dollars per share, compared with 10.62 million US dollars, or 0.35 US dollars per share, in the same period last year. The loss range expanded but was less than the market expectation, which had expected a loss of US $0.97 per share. By region, U.S. revenue in the second quarter of 2019 was $78.1 million, down 2% from $79.9 million a year earlier. The year-on-year decline in U.S. revenue was mainly due to the effect of customer destocking related to the company's previously announced changes in certain large volume product orders. International revenue was $15.5 million, up from $16.2 million in the same period last year. It's down 4% on the reported basis and up 2% on the fixed currency basis. Gross profit in the second quarter of 2019 was $63.9 million, down 6% from $67.9 million in the same period last year. Gross margin was 68% in the second quarter of 2019, compared with 71% in the same period last year. Operating expenses in the second quarter of 2019 were $90.5 million, up 19% from $76.1 million a year earlier. The year-on-year increase in operating expenses was mainly driven by US sales and marketing personnel costs and expenses related to clinical trials. Nevro currently expects global revenue to be between $368 million and $374 million in 2019. It is reported that nevro Corp., founded in 2006 and headquartered in Redwood City, California, USA, has 308 full-time employees. It is a medical device company specializing in spinal cord stimulator. As of 17:36 EST, nevro was down 0.22% in after hours trading to $63.2.
Leaders from the device registration department of the State Food and drug administration came to Beijing to investigate the management of clinical trials of medical devices 2020-12-09
On August 2, 2019, Du Huiqin, deputy director of the Department of medical device registration and management of the State Drug Administration, led a team to Beijing for investigation and discussion with representatives of Beijing Municipal Drug Administration, some medical institutions and manufacturers, listened to the report on the development of clinical trials of medical devices in Beijing, and discussed the revised contents of the quality management standard for clinical trials of medical devices. Wang Fuyi, member of the party leading group and deputy director of Beijing Municipal Drug Administration, attended the forum and introduced the filing of medical device clinical trial projects and institutions in Beijing in 2019, as well as the supervision and spot check of clinical trials. The participants mainly focused on the content of "quality management standard for clinical trials of medical devices", combined with the difficulties and problems in the process of clinical trials of medical devices, put forward opinions and suggestions. Deputy director Du Huiqin fully affirmed the management of clinical trials of medical devices in our city and emphasized: first, we should carry out research on clinical trials supervision, scientifically use supervision data, and provide technical support for registration review and approval; second, we should establish the sense of responsibility of enterprises, strengthen their own clinical management ability, and strengthen the management of clinical trial partners; third, we should strengthen the management of clinical trial partners The key point is to investigate and deal with the authenticity of clinical trials.
Free experience of medical devices "four essentials" to prevent being cheated 2019-08-09
Using free experience to promote medical devices is a marketing method often used by medical device enterprises. Some operators have illegal behaviors such as false publicity and illegal operation in the process of such business activities, which bring hidden dangers to consumers. Recently, Jinan Municipal Market Supervision Bureau of Shandong Province reminded consumers that to participate in the consumption of free experiential medical devices, they should achieve "four requirements". To fully understand the product information. Before participating in the free experience, consumers should fully understand the basic information of medical device products, confirm whether the products are approved legal products, carefully read the labels and instructions of the products, understand the scope of application, precautions and other information of the products, and do not listen to the exaggeration and false publicity of the businesses. Product registration information can be found on the website of the State Drug Administration. It is necessary to analyze the qualification of operators. To operate class II and class III medical devices, it is necessary to obtain class II medical device business record certificate and medical device business license respectively. Consumers should distinguish whether the operator has legal business qualification. To grasp their own health. Consumers should fully understand their health status, consult doctors or other professionals, and decide whether to participate in the experience purchase after confirming that their physical conditions permit. We should choose regular medical institutions. Consumers should be careful to participate in the free experience of medical devices. If they have diseases, they should choose regular medical institutions for treatment. They should not be greedy to save trouble and blindly listen to the propaganda of businesses, so as to avoid unnecessary health and property losses.
Xinshao: it will be a history for individual businesses to deal in drugs, class II and class III medical devices 2019-08-09
On August 6, the staff of Xinshao County Market Supervision Bureau went into the individual pharmacies under its jurisdiction to carry out the publicity and launch work of cleaning up the business qualification of individual businesses engaged in the operation of drugs, class II and class III medical devices. The entire clean-up will continue until November 30, 2019. The purpose of this qualification clearance action is to comprehensively standardize the operation of drugs, class II and class III medical devices in Xinshao County, and to eliminate the phenomenon of individual businesses operating drugs, class II and class III medical devices. The Bureau will organize the drug equipment unit to find out the market subject qualification of the drug equipment retail business units in the whole county and establish a standing book, and then distribute the standing book to the administrative examination and approval unit and each supervision office. According to the division of responsibilities, the supervision offices, the administrative approval units and the drug and equipment units under the jurisdiction of Xinshao market supervision bureau cancel the individual business license, handle the enterprise business license and change the related matters of drug and equipment license. In November, the Bureau will clean up the qualification of market entities of drug and equipment retail business units in the whole county again, and standardize the market entities of individual drug and equipment business according to the requirements, so as to ensure that the regulation rate reaches 100%.  
Registered medical device company? You need to meet these conditions 2019-08-09
Medical device industry involves medicine, machinery, electronics, plastics and other industries. It is a high-tech industry with interdisciplinary, knowledge intensive and capital intensive. It is an industry with rapid development in modern society. It is also a strategic emerging industry supported by the state.     So how to register a medical device company in Shanghai? Next, Yu Shang Xiaobian will tell you something. Medical devices can be divided into three categories according to their risk degree, and the processing conditions of different types of medical devices are also different. Today, I will focus on the registration of class II medical device companies. First of all, the registration should have the conditions 1. It shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state; 2. It shall have business and storage sites suitable for its business scope and scale; 3. If the storage conditions are suitable for the business scope and scale, and all the medical devices are entrusted to other medical device business enterprises for storage, the warehouse may not be set up; 4. Have a quality management system suitable for the medical devices; 5. Have the ability of professional guidance, technical training and after-sales service corresponding to the medical devices, or agree to provide technical support by relevant institutions. Class II medical device company registration process is the same as the general company registration process, but there is an on-site inspection and filing process. About the filing of class II medical devices. Class II medical devices refer to those with moderate risk, which need strict control and management to ensure their safety and effectiveness. According to the regulations of the measures for the supervision and administration of the operation of medical devices, those engaged in the operation of class II medical devices shall file with the local municipal food and drug administration, fill in the record form for the operation of class II medical devices, and submit the following information: 1. Copy of business license; 2. Copies of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality; 3. Description of organization and department setting; description of business scope and operation mode; 4. A copy of the geographical location map, plan of the address of the business site and warehouse, the certificate of the property right of the house or the lease agreement (with the certificate of the property right of the house attached); 5. Catalogue of business facilities and equipment; catalogue of business quality management system, working procedures and other documents; 6. Other supporting materials. The requirements for the area of the warehouse are different with the operation of medical devices. If the business is a disposable medical device enterprise for blood transfusion, infusion and injection, the warehouse area should not be less than 100 square meters (different regions have different policy requirements). If the enterprise is engaged in three types of medical devices, it needs to apply for a medical device business license. The term of validity of the medical device business license is 5 years. If the term of validity needs to be extended, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative license. If a registrant fails to apply for renewal of registration within the specified time limit; the mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration can not meet the new requirements; if the medical devices used for treating rare diseases and dealing with public health emergencies are not completed within the specified time limit, the renewal of registration will not be allowed.
The 82nd China Medical Devices International Fair 2019-04-11
From October 19 to 22, 2019, the 82nd China International Medical Devices (Autumn) Expo (CMEF) with the theme of "intelligent reconstruction of the future" was solemnly held at the International Exhibition Center of China Railway Expo City on the west coast of Qingdao. As a leading enterprise in the domestic blood collection industry, Guizhou Tiandi Medical Equipment Co., Ltd. participated in the exhibition with all the products, fully showing the elegant demeanor of independent research and innovation development. The 82nd China international medical device (Autumn) Expo (CMEF) During the exhibition, Tiandi medical equipment focused on PrP and conventional blood collection. In front of the exhibition stand, many representatives from hospitals at home and abroad stopped to learn about the products and left their contact information. Tiandi medical equipment has always been focusing on the consumable products such as blood collection vessels, taking the service of human health as the action guide, constantly innovating, and keeping up with the development of the industry with high-quality products. As the main product, the PrP blood collection vessel has become a highlight of the exhibition and attracted many professional visitors. The exhibition for four consecutive days actively promoted the company's products and brands, and effectively promoted the expansion of the company's external market. Hospital representatives stop to understand the products Professional visitors to the booth to understand the products

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