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Latest measures for supervision and management of the quality of medical devices

Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices in order to
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01
2020-09

What is the most promising medical device?

Time of issue: : 2020-09--01 Number of views : 0
According to the statistics of medical device market in Asia, which accounts for 25% of the total medical device market in November, it is worth comparing with the medical device market in the future. So. What kind of medical device products developed and produced by Asian countries have the most market prospects?   According to the statistics released by the United Nations, the total population of Asian countries accounted for about 60% of the global total population in 2013, but the medical device market in Asia only accounted for 15% of the total sales of the international medical device market. With the aging population of major countries, the medical device industry and market in Asia will usher in a huge space for development.   So, for those Asian countries that are approaching the aging society in Europe and the United States, especially those in China, Japan, South Korea, Hong Kong, Taiwan and Singapore, which have entered the aging stage, what kind of medical device products will have the most market prospect? This is a major issue of great concern to the industry. Because this is related to the future and destiny of the medical device industry. According to the investigation, the author summarizes as follows:   Miniaturized medical devices   With the increasing popularity of medical means including interventional therapy, medical departments are calling for the miniaturization of medical devices. The digital technology is becoming more and more mature, which lays a foundation for the production of miniaturized electronic medical devices. Among them, the most famous example is new electronic medical devices such as "swallowable capsule endoscopy". Another example is that foreign manufacturers have developed a "bracelet type multifunctional electronic diagnostic instrument" that can be worn on the wrist in recent years. It can be used to measure blood glucose, blood pressure, heart rate and other important life indexes. As soon as this kind of new product is launched, it is welcomed by the majority of elderly consumers.   "Zero defect" products   For implantable medical devices, especially cardiac pacemakers, insulin pumps and implantable electrodes, the quality requirements must be absolutely reliable "zero defect products", because even 1% defect rate of these products (such as electronic coil short circuit) will cause fatal consequences. The popular electronic diagnostic instruments also belong to "zero defect" products, such as blood glucose meter and blood pressure meter. If the display figures are not correct, patients will be misled and they will lose the opportunity to go to the hospital and get timely treatment by doctors.   Long life battery   At present, the battery power supply of most of the battery products is very short, so it is troublesome for many patients to use the battery for power supply. To solve this problem, developed countries in Europe and the United States have developed long-life rechargeable batteries with a service life of up to 10 years, which saves the trouble of frequently replacing batteries. The more encouraging news is that a European company has developed a kind of "life heat source battery" that does not need to be charged. It skillfully uses the heat emitted by the human body into energy and converts it into electric energy, which is stored in the battery for medical devices. This new battery with small volume is most suitable for all kinds of wearable medical device products, which can avoid the trouble of frequent battery replacement by consumers.   Performance upgrade products   At present, there is room for upgrading many medical devices in the market. For example, B-ultrasound is one of the commonly used diagnostic instruments in primary hospitals or clinics. According to western researchers, it only costs a small amount of money to install a chip in the B-ultrasound machine, then the internal organs diagnosis results of patients in the B-ultrasound room can be transmitted wirelessly to the computer display screen of the attending doctor's office through WiFi (or the local area network in the hospital), so that the doctor can know the patient's specific condition at the first time and make a diagnosis in advance.   This can save doctors a lot of time. There is also room for upgrading the existing implantable electronic medical devices such as cochlear. If the cochlear circuit is upgraded, the deaf mute patients will have a better hearing range. If the electronic medical devices, such as electronic hearing aids, are upgraded, they can have more functions and greatly improve the quality of life of patients.   All in all, the above-mentioned new medical devices will become the most popular new products for hospitals and patients in Asia, and their market development potential is very great. For medical equipment enterprises, while improving and developing such products, they also need a certain spirit of bold innovation and constant breakthrough to develop
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01
2020-09

Notice of State Food and Drug Administration on relevant work requirements for registration after adjustment of medical device management category

Time of issue: : 2020-09--01 Number of views : 0
Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration) In order to further standardize the registration management of medical devices, in accordance with the relevant provisions of the measures for the administration of registration of medical devices and the notice on printing and distributing the Interim Provisions on Further Strengthening and standardizing the registration management of medical devices (gsyjx [2008] No. 409), the implementation requirements of relevant registration work after the adjustment of the management category of medical devices are hereby notified as follows: 1. The management category has been adjusted from the high category to the low category (1) for the medical devices that have been approved for registration, if there are no other changes in the products within the validity period of the medical device registration certificate, the re registration matters shall be implemented in accordance with Article 6 of gsyjx [2008] No. 409 document, and the medical device registration certificate within the validity period shall remain valid. The manufacturer shall apply to the corresponding food and Drug Administration for re registration according to the changed category before the expiration of the validity of the medical device registration certificate. In case of any change specified in Articles 34 and 38 of the administrative measures for registration of medical devices or Article 19 of the regulations on the administration of instructions, labels and packages of medical devices within the validity period, the production enterprise shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category. (2) the original examination and approval department will no longer accept applications for re registration of products from the date of adjustment of management categories. If the application has been accepted but no approval decision has been made, the original acceptance department shall continue to carry out technical review and administrative examination and approval in accordance with relevant laws and regulations; if the registration is approved, the medical device registration certificate shall be issued according to the original management category. 2. The management category has been adjusted from the low category to the high category (1) for medical devices that have been approved for registration, the manufacturer shall apply for change and re registration in accordance with Article 35 of the administrative measures for registration of medical devices. For those who apply for change and re registration according to the regulations, the original registration certificate shall remain valid within the validity period before the re registration approval decision is made. If it fails to apply for re registration within 6 months as required, the original registration certificate shall not be used any more. (2) the original examination and approval department will not accept the application for re registration of products from the date of management category adjustment. If the application has been accepted but no approval decision has been made, the original acceptance department shall carry out technical review and administrative examination and approval in accordance with the requirements of relevant laws and regulations, except for the special provisions of the State Food and drug administration; if the registration is approved, the medical device registration certificate shall be issued according to the original management category. Within 6 months after the product has obtained the registration certificate, it shall apply to the corresponding food and drug regulatory department for change and re registration. (3) in case of any change specified in Article 38 of the administrative measures for the registration of medical devices or Article 19 of the provisions on the administration of instructions, labels and package labels of medical devices, the manufacturer shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category. III. information requirements for handling relevant registration applications after adjustment of management category While submitting the application materials according to the relevant provisions, the production enterprise shall also submit the specifications, standards and other materials approved at the time of original registration. In addition, it is also necessary to submit a self assurance statement on the authenticity of the information to ensure that the application materials are the same as those approved by the original registration examination. When necessary, the food and drug regulatory department may verify the authenticity of the application materials. For products with increased management categories, food and drug regulatory authorities may require ent
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01
2020-09

Which medical device products are suitable for marketing through clinical evaluation?

Time of issue: : 2020-09--01 Number of views : 0
The State Food and Drug Administration released the draft of technical guidelines for clinical evaluation of medical devices, which has attracted extensive attention and opened up a new way for new products to be listed in China. In June 2015, the guidelines came into effect.   Clinical evaluation or clinical trial   At present, the new medical device products listed in China have formed a relatively clear path: the first type of device is put on record, and most of the three types of devices require clinical trials, especially the products in the catalogue of category III medical devices subject to clinical trial approval. For class II devices and some class III devices, clinical evaluation or clinical trials are two options.   Most companies want to choose clinical evaluation rather than clinical trial. Cost is one of the important reasons. Clinical trials cost a lot and the results are unknown. It is a high-risk investment. A clinical evaluation report (CER) is not cheap. At present, most of the quotations of cro companies are around 200000-300000 yuan, but they are still lower than the investment in clinical trials. Time consuming is another important reason. Considering the time of preparation and start-up, it is usually a good result that a project can be completed in 2-3 years. The clinical evaluation report can be completed in about 3-4 months, which can advance the launch time of new products by at least 1-2 years. Considering that the medical device products are updated quickly and the life cycle is short, the shortened 1-2 years is very valuable for manufacturers.   Based on the above reasons, many companies place high hopes on clinical evaluation, so that the quotation of clinical evaluation report rises. However, after reading the technical guidelines for clinical evaluation of medical devices and analyzing the current situation of cmde, it is not difficult to find that the guiding principles issued by the drug regulatory department are not intended to open a fast channel for manufacturers to quickly market a large number of new products, but to "improve the clinical evaluation by distinguishing different clinical evaluation situations and setting corresponding requirements reasonably" It can reduce the burden of management counterpart   It's difficult to go public through cer   For the products with low risk, stable manufacturing process, no major changes in product design, and a large amount of safety and effectiveness data have been accumulated in the past, it is a waste of resources and time to require the manufacturer to do another clinical trial to provide data. Cer provides a way to use the existing data to complete the evaluation of product safety and effectiveness. However, for innovative and risky devices, it is difficult to complete the listing through cer.   One of the difficulties: it is difficult to find a suitable analogy product. The ideal contrast product is a product which has little difference with the application product and has been listed in China. There are not many products that meet this requirement, especially those with technological innovation. In addition, a hidden condition is that the comparison product is better than the previous generation of its own company. This requirement mainly comes from the comparison of production process. If it is not the products of our company, it is difficult to get the production information and parameters. At present, cmde requires to prove the legal source of data. In Article 6 of the notice of the State Administration of food and Drug Administration on the implementation of the administrative measures for the registration of medical devices and in vitro diagnostic reagents issued on November 4, 2015, it is emphasized that "if a manufacturer carries out clinical evaluation in accordance with Article 6 of the guiding principles for clinical evaluation of medical devices, the manufacturer of the same type of medical device is used For technical and clinical data, the applicant should submit the authorization for the use of the same kind of medical device production process, clinical data and other data, so as to eliminate the possibility of obtaining the other party's company information through non-public channels.   Difficulty 2: unable to find enough clinical literature. For completely innovative products, it is very difficult to take the CER Road, because of the lack of previous literature and data, cmde will also carefully consider approving innovative products to be listed through cer for risk consideration. If the imported products belong to category II in foreign countries and are not put on the market for a long time without clinical trials, there will be few literatures. Therefore, considering to meet the requirements of this article, products with a long time to market (relatively large number of clinical literature), no significant improvement in production process (no difference or little difference in comparison), and
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30
2015-11

High performance medical devices are key areas in the 13th five year plan

Time of issue: : 2015-11--30 Number of views : 0
[global medical resources] China's 13th five year plan for the development of pharmaceutical industry and health care has been basically completed and has entered the stage of soliciting opinions. Among them, medical informatization, high-performance medical devices and biomedicine will become the key development areas. These three sub sectors will also become the key support objects of the state during the 13th Five Year Plan period, highlighting investment opportunities. On March 30, this year, the general office of the State Council issued the national health service system planning outline (2015-2020), pointing out that in the next five years, China will carry out the healthy China cloud service plan, actively apply new technologies such as mobile Internet, Internet of things, cloud computing, wearable devices, etc., to promote health information services and smart medical services that benefit the whole people, and promote health The application of Kangda data will gradually change the service mode and improve the service ability and management level. At the 2014 China Health conference, Zhang Feng, deputy director of the planning and Information Department of the national health and Family Planning Commission, said that during the "13th five year plan" period, the medical and health industry will be the focus of national informatization development, which has been included in the national key plan for network security and informatization construction. "Internet plus medicine" will bring about changes and opportunities for the whole big health industry. According to statistics, in 2014, the total amount of venture capital in the field of internet medical care has exceeded US $4.1 billion, an increase of 124% over 2013, involving a total of 258 companies, mainly including big data analysis, medical consumer participation, digital medical equipment, telemedicine, personalized medicine and population health management. Pharmaceutical e-commerce is also facing significant development opportunities. On May 28, 2014, the State Food and Drug Administration (SFDA) released the "Internet food and drug business supervision and management measures (Draft)", which pointed out that it was planned to open the online sales of prescription drugs, reduce the access threshold for drug sellers, and allow pharmaceutical e-commerce to choose the third-party logistics distribution. Under the "Internet plus" strategy, the approach is expected to come out soon. "Made in China 2015" released on May 8, this year, pointed out that the biomedical field is the key area to vigorously promote the development of breakthroughs: "to develop new products of chemical drugs, traditional Chinese medicine and biotechnology drugs for major diseases, focusing on new mechanisms and new target chemicals, antibody drugs, new structural protein and peptide drugs, new vaccines, and innovations with outstanding clinical advantages New Chinese medicine and personalized treatment drugs. " The biomedical industry has a lot of subdivided fields with high technology content and broad prospects. Taking precision medicine as an example, on March 26 this year, the Ministry of science and technology first proposed China's precision medical plan, and pointed out that it would invest 60 billion yuan in this field by 2030. "Made in China 2025" also proposes to "improve the innovation ability and industrialization level of medical devices, focus on the development of high-performance diagnosis and treatment equipment such as imaging equipment and medical robots, high-value medical consumables such as fully degradable vascular stent, and mobile medical products such as wearable and remote diagnosis and treatment. To achieve breakthroughs and applications of new technologies such as biological 3D printing and induced pluripotent stem cells ". Due to the late start, low starting point and insufficient research and development, the technical level of medical device industry in China is relatively backward. At present, there are about 15000 medical device manufacturers in China, but up to 90% of the enterprises' income scale is less than 20 million yuan. The 13th five year plan will be a great opportunity for the development of high performance medical devices in China. For medical device manufacturers, there is a blue ocean ahead.
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15
2015-10

Nanchang Xiangyi medical device marketing network

Time of issue: : 2015-10--15 Number of views : 0
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