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Country SFDA issued a document: 22 kinds of instruments may be prohibited from commissioned production

According to the regulations on the supervision and administration of medical devices, China The SFDA organized and adjusted the catalogue of high-risk implantable medical devices prohibited from commissioned production to form the catalogue of medical devices prohibited from commissioned production (Draft for comments) (hereinafter referred to as the catalogue). On November 19, the public solicited opinions. The adjusted catalogue of high-risk implantable medical devices prohibited from commissioned production includes the following three types and 22 kinds of medical devices: 1、 Partially active implantable medical devices 1. Implantable pacemaker (12-01-01) 2. Implantable cardioverter defibrillator (12-01-02) 3. Implantable cardiac contractility regulator (12-04-01) 4. Implantable circulatory AIDS (12-04-02) 2、 Partially passive implanted medical devices 1. Sports injury soft tissue replacement implant (allogeneic tissue) (13-02-02) 2. Acrylic resin bone cement (13-05-01) 3. Allogeneic bone repair materials (13-05-03) 4. Dural patch (13-06-04) 5. Aneurysm clip (13-06-05) 6. Intracranial stent system (13-06-06) 7. Intracranial embolization instrument (13-06-07) 8. Intracranial coil system (13-06-08) 9. Flow guiding device for intracranial aneurysms (13-06-11) 10. Cardiovascular implants (excluding peripheral vascular stents) (13-07) 11. Shaping filling material (13-09-01) 12. Injection filler for plastic surgery (13-09-02) 13. Breast implants (13-09-03) 14. Tissue engineering scaffold materials (13-10) 3、 Other 1. Absorbable surgical anti adhesion dressing (14-08-02) 2. Tissue engineered biological amniotic membrane (16-07-09) 3. Corneal stromal slice (16-07-10) 4. Vaginal patch and pelvic floor patch (18-04-02) Note: the number in brackets after the product name is the category code of medical device classification catalogue (2017 Edition). Compared with the 2014 version, the adjusted catalogue will increase the number of medical devices prohibited from commissioned production to 22 and be more detailed. For example, the item of "plastic implants (agents)" listed in the original catalogue is subdivided into plastic filling materials, plastic injection fillers, breast implants and tissue engineering scaffold materials in the new catalogue. The catalogue of prohibited commissioned production of medical devices (Exposure Draft) is a timely adjustment under the continuous improvement of laws, regulations and standards and the continuous development of science and technology. The implementation of the catalogue will play a beneficial role in reducing adverse events of related products and ensuring product * * in the future.

Medical bone needle, Kirschner wire, steel needle, bone traction needle, titanium alloy + stainless steel, made by Dabang

Country The Home Drug Administration named: these medical devices are unqualified!

The notice shows that in order to strengthen the supervision and management of medical devices and ensure the quality of medical devices * * is effective The National Drug Administration organized the product quality supervision and sampling inspection of five varieties such as intervertebral fusion cage and semiconductor laser treatment machine, and a total of 12 batches (sets) of products did not meet the standards. The details are as follows: 1、 Medical device products whose sampled items do not meet the standards （1） Two batches of interbody fusion cage: produced by Dezhou Jinyue Medical Instrument Co., Ltd., the surface roughness involved does not meet the standard. （2） 1 set of semiconductor laser treatment machine: produced by Cao group, Inc. Siro group, the marking involved does not meet the standard provisions. （3） One carbon dioxide laser treatment machine: produced by Wuhan jinlaite optoelectronics Co., Ltd., which involves the external marking of equipment or equipment components, and the accuracy and marking of controller and instrument do not meet the standard provisions. （4） 1 set of ultrasonic equipment produced by Weihai Technology Co., Ltd. or external imaging equipment that does not meet the requirements of Weihai Technology Co., Ltd. （5） 7 operation shadowless lamps: produced by Changzhou Meiya medical Lighting Co., Ltd., Hebei Yi'an Aomei Medical Equipment Co., Ltd., Hengzhi medical equipment (Shanghai) Co., Ltd., Shandong KANGYI Medical Equipment Co., Ltd., Shandong xinyuchen Medical Equipment Group Co., Ltd., Shandong Xinhua Medical Equipment Co., Ltd. and Shanghai Jishun medical equipment manufacturing Co., Ltd., involving protective grounding impedance, central illumination The single shutter illumination measurement and total irradiance do not meet the standard requirements. The above sampling inspection does not meet the standard provisions. See the annex for the specific conditions of products. 2、 For the above products found in the sampling inspection that do not meet the standards and regulations, China will be punished The drug administration has asked the provincial drug administration where the enterprise is located to make administrative decisions in time and publish them to the society in accordance with the requirements of the regulations on the supervision and administration of medical devices, the measures for the supervision and administration of the production of medical devices and the measures for the administration of the recall of medical devices. The provincial drug supervision and administration department shall urge enterprises to conduct risk assessment on products that do not meet the standards, determine the recall level according to the severity of medical device defects, take the initiative to recall products and disclose the recall information; Urge enterprises to find out the causes of unqualified products as soon as possible, formulate rectification measures and rectify them in place on schedule.

Another Internet giant enters the medical device market, "co-builder" or "spoiler"?

Internet giants are scrambling for medical devices. Recently, Tiktok e-commerce has issued a public notice on the new [medical devices] category management specification, integrating the medical devices under various categories to make the medical devices into a separate category. This means that Tiktok is officially working in the field of medical devices. Previously, Internet giants, including Tencent, Alibaba, Baidu, meituan, Kwai, Xiaomi, pinduoduo and so on, have laid out medical devices: they either take shares in medical device enterprises by means of investment, or lay out their own layout in person, and invest in people, money and investment channels, thus marking their own base in the medical device Jianghu. To this end, Shao Qing, the founder and CEO of Beijing Pharmaceutical enabling technology Co., Ltd., was interviewed by [medical observer]. Shao Qing expressed his views on this trend: Q: Internet giants are laying out medical devices, which reflects the giants' consideration? Is the entry of Internet giants a "co builder" or a "troublemaker" in the development of the medical device industry? A: Medical devices, like drugs, are a category with relatively high gross profit margin, and capital pursues profit. Therefore, in the future, all platforms will make medicine and medical devices, but selling drugs may be more difficult than selling health products and medical devices. The entry of Internet giants is not only a "co builder" but also a "troublemaker" on the development of the medical device industry. They are "troublemakers" in the existing market and will seize part of the market; At the same time, they are also "co builders", providing better consumption scenes for product sales, such as live broadcasting, so as to better promote products.

2022-8-10 An overview of the scientific research and practice of medical device regulation in China

            Proposed by Japanese and American scientists in the early 21st century, regulatory science has become one of the most important research fields in regulatory affairs, especially in the field of medical device regulation, which has great application potential.              Medical device regulatory science is the application of regulatory science in the field of medical devices. The research on medical device regulatory science is helpful to encourage technological innovation, promote industrial development, and ensure that medical institutions can use medical devices with reasonable price, effective and safe. However, looking at the status quo of medical device regulatory scientific research in various countries and regions, few of its achievements can be systematically applied to regulatory practice, and scientific supervision is mainly based on traditional models such as expert review, format review and empirical data. The efficiency of medical device approval and the speed of industrial innovation still need to be improved. , therefore, to strengthen the regulation of medical equipment scientific research, focus on new situations and new problems in the medical field, focus on biological technology, material technology, information technology application in the field of medical apparatus and instruments, emerging technologies such as strengthen the innovative products and interdisciplinary product evaluation, review and supervision of scientific research, in a timely manner to solve the emerging technology products and regulatory issues of performance evaluation, Improve the scientific level of medical device research and development, review and production process, enhance the ability to evaluate and review the safety and effectiveness of new products, and ensure that supervision follows the pace of scientific and technological progress and industrial innovation and development.                            In recent years, the rapid progress of biomaterial technology, the rapid development of information and communication technologies such as Internet of things, 5G, artificial intelligence and big data, and gradually widely used in the field of medical devices, has brought great challenges to the traditional regulatory model. At the same time, the rapid development of China's medical device industry, innovative medical devices constantly emerge, the people are full of expectations for the application of advanced technology in innovative medical devices, put forward new requirements for the development of medical device supervision and scientific research. The formulation of reasonable and effective regulatory laws and regulations will directly affect the development of the medical device industry, and indirectly affect the healthy development of the entire medical industry. Specifically, national regulatory laws and regulations can help protect the market and support industrial development, but the main goal is to achieve the best medical services through safe and clinically effective medical devices. So regulators need to think about whether the latest regulations are better at achieving that goal than previous ones, and whether they can estimate how much they will deter risky devices from coming to market. In general, the scientific research on medical device supervision in China mainly comes from three aspects.              First, regulatory authorities need more scientific decision-making methods and tools to support regulatory work. The lack of sufficient scientific basis for regulatory departments leads to the situation that regulatory work relies heavily on the results of expert reviews, and a limited number of expert reviews is not enough to become the whole basis for regulatory work. From another perspective, if medical equipment manufacturers use a similar, product validation method based on expert opinion (mainly based on interviews with patients or expert), may be regarded as a lack of evidence and cannot get the confirm of regulators, this is because regulators wouldn't use a limited number of expert opinion as a review of all the basis. Therefore, regulatory authorities need to have more scientific methods and tools to review and evaluate product safety and effectiveness. In recent years, regulatory research has vigorously promoted the application of data decision-making in regulatory work, and more effective data analysis methods and tools have been used to support various reviews and decisions in regulatory work. At the same time, any regulatory regulation has benefits, costs and risks. To design regulatory regulations by optimizing the ratio of benefits to risks, it is necessary to understand the interdependence of economy and technology. Without understanding these interrelationships, regulatory authorities will lack a scientific basis for decision-making, and regulatory actions may be blind. Therefore, it is a key task of regulatory science to study these interdependencie