Warmly congratulate Kangsheng Jiutai for once again obtaining high-tech enterprise certification

Heartfelt congratulations to Zhengzhou Kangsheng Jiutai Medical Equipment Co., Ltd. for successfully passing the re-certification as a high-tech enterprise in 2020, and for being awarded the "High-tech Enterprise Certificate" on December 4, 2020, jointly issued by Henan Provincial Department of Science and Technology, Henan Provincial Department of Finance, and Henan Provincial Tax Service, State Taxation Administration.

Zhengzhou Kangsheng Jiutai Luoyang Longmen team building and tourism activities

Zhengzhou Kangsheng Jiutai Luoyang Longmen Team Building and Tourism Activities Zhengzhou Kangsheng Jiutai Medical Equipment Co., Ltd., established on July 19, 2007, is a modern high-tech enterprise specializing in the production of high-end medical equipment. Located in Zhengzhou Airport Economy Comprehensive Pilot Zone, the first airport economic development pilot zone in China, it covers an area of 20,000 square meters. Focusing on high-end, precise, and cutting-edge technology for product R&D, the company specializes in the research, development, production, and sales of high-end medical equipment. Due to the epidemic at the beginning of the year, businesses in all regions of the country were greatly affected. After the epidemic subsided, under the leadership of the company's management, all colleagues worked together to achieve good results in the first three quarters. Compared with the same period last year, sales in various regions have made significant progress, and the number of newly opened hospitals has also increased significantly. To express gratitude for the tireless efforts and selfless dedication of all colleagues in the company's development process, to promote employee communication, strengthen seamless connection between teams, enhance friendship, and strengthen cohesion, and to promote the company's cultural concepts and enrich employees' after-work cultural life and broaden their horizons, the company organized a Luoyang team-building and tourism activity from September 28th to 29th, 2020. Luoyang, as the capital of thirteen dynasties, possesses unparalleled historical heritage. Luoyang, abbreviated as "Luo", also known as Luoyi and Luojing, is a prefecture-level city in Henan Province. Luoyang boasts a 5,000-year history of civilization, a 4,000-year history as a city, and a 1,500-year history as a capital. As far back as 500,000 to 600,000 years ago in the Paleolithic era, ancestors thrived in Luoyang. Yu divided the land into nine states, and He and Luo belonged to ancient Yuzhou. Luoyang is one of the cradles of Chinese civilization, the eastern starting point of the Silk Road, and the center of the Grand Canal during the Sui and Tang dynasties. Thirteen dynasties established their capitals in Luoyang throughout history. The rise and fall of dynasties can be seen in the city of Luoyang. The Longmen Scenic Area is known for its beautiful mountains and clear waters. It has been considered the most beautiful of the eight scenic spots in Luoyang since ancient times: Longmen Mountain Scenery. Bai Juyi, a great Tang Dynasty poet, once said: "Among the four suburbs of Luoyang, the most beautiful mountains and waters are those of Longmen." Moving forward, we arrive at the Longmen Bridge spanning the Yi River. Where the bridge and the scenic area road intersect, two bridge holes were cleverly constructed, naturally called "Longmen". Ahead lies the area of the Longmen Grottoes in Xishan Mountain. The Longmen Grottoes began to be carved during the period before and after Emperor Xiaowen of the Northern Wei Dynasty moved the capital from Pingcheng (present-day Datong, Shanxi Province) to Luoyang. It experienced its heyday during the Tang Dynasty, resulting in its current scale. The Longmen Grottoes are the most concentrated place where imperial families and nobles made vows to create statues. Carving grottoes into mountains is more convenient and durable than building temples with bricks and stones. Therefore, cave temples integrating architecture, painting, and carving art appeared in ancient India. This cave temple art, along with the missionary activities of monks, spread to the frontiers and inland areas of China, merging with China's national characteristics and traditional artistic techniques and styles, becoming a unique carving and painting craft in China. The Longmen Grottoes we are visiting today are one of the treasures among China's numerous temple groups. In addition to the favorable conditions mentioned earlier, the Longmen Grottoes group's carvings also benefit from an important natural condition. The cliffs on both banks of the Yi River belong to the Cambrian and Ordovician limestone strata of the Paleozoic Era. The stone is hard, with a tight structure, not prone to weathering and large-scale cracking, making it very suitable for artistic statues. Compared with other sandstone, it has favorable conditions for preservation. Tourists walk along the suspended walkways, with many stone Buddha statues within reach on the cliffs. Along the scenic area's path, the charm of Luoyang peony stones is also showcased to tourists. Peony stone is a naturally formed strange stone, originating from Wulong Village, Koudian Town, Luoyang City, Henan Province, China. According to geological dating, it was formed approximately 300 to 400 million years ago. Corresponding to the long cultural history of Luoyang peonies, it is considered a specialty of Luoyang. Peony stone has a black base color, with many white or green crystals evenly distributed on the stone body, resembling peonies of various colors, some budding, some in full bloom, hence the name "Peony Stone". The peony stone hometown is the world-famous Wulong Village, Koudian Town, Yanshi City, located more than ten kilometers east of the Longmen Grottoes in Wan'an Mountain. This town was named after Kou Zhun, a famous official of the Song Dynasty, stayed there, and peony stones are hidden in the folds of Wan'an Mountain. Moving forward, we reach the foot of the Fengxian Temple, where the Lushan Buddha stands. Climbing the steps in front of us leads to the Fengxian Temple, where the largest Buddha statue in the Longmen Grottoes is located. Fengxian means to worship ancestors. The Fengxian Temple is the largest, most artistically refined, and most imposing cave in the Longmen Grottoes, and it is also the iconic landmark of the Longmen Grottoes. The Fengxian Temple is approximately 40 meters deep from east to west and 36 meters wide from north to south. According to relevant materials and expert research, the Fengxian Temple was initially built in the sixth year of Yongwei, when Wu Zetian was made empress, after 655 AD. It was completed in the second year of Shangyuan, December 30th, 675 AD, taking about 21 years. The central figure is the Lushan Buddha! The inscription on the left, "The Record of the Great Lushan Buddha Niche," states: "Built by Emperor Gaozong of the Great Tang Dynasty." The Buddha's body is 85 feet tall, the two Bodhisattvas are 70 feet tall, and the Kasyapa, Ananda, and Vajra deities are each 50 feet tall. The layout of the Fengxian Temple includes: one Buddha, two disciples, two Bodhisattvas, two Heavenly Kings, two yakshas, and two attendants. The main statue is the Lushan Buddha, seated in the center in a cross-legged position. The entire statue is 17.14 meters tall, with the head 4 meters high and the ears 1.9 meters high, making it the largest in the Longmen Grottoes. Its face is plump and elegant, with eyebrows like crescent moons, affectionate eyes, a slight smile, and overflowing kindness. Her wise eyes look slightly downward, her gaze meeting the upward gaze of those who worship, causing an emotional tremor. Some compare the Lushan Buddha to the Eastern Mona Lisa, saying she is the embodiment of kindness, beauty, and grace. Look at her slightly upturned lips, downcast eyes, slightly downward gaze, curved eyebrows like hooks and moons, and a face full of smiles, a kind and benevolent demeanor. Every time you see the smile of the Lushan Buddha, you feel refreshed. No matter from which angle you look at her, her gaze will interact with you, like the inquiry of a wise person, the concern of an elder, and the love of a mother. Legend has it that Wu Zetian's virtues almost perfectly matched the image of the Lushan Buddha. It is evident that the image of Lushan is, to a certain extent, a true portrayal of Wu Zetian. The Longmen Grottoes are a rich and diverse museum, providing extremely valuable materials for research on China's history, religion, culture, art, medicine, and more. The worship platform is spacious, facing the Lushan Buddha statue in the Fengxian Temple. This is the best viewing platform for taking photos and appreciating the Longmen Grottoes. Due to the inclement weather and light rain, the activities concluded for the day. Reflecting on the past is to better grasp the future. This team-building and tourism activity not only enriched employees' leisure lives and allowed them to experience the company's warmth and care, but also enhanced the company's cohesion and fully demonstrated the company's team spirit. It allowed employees to relax, cultivate their sentiments, and return to work with renewed enthusiasm, striving to achieve better results in the fourth quarter and achieve the annual goals.

At the symposium on centralized volume-based procurement of drugs and high-value medical consumables, Han Zheng emphasized the need to build consensus, deepen reforms, win public trust, and unswervingly advance centralized volume-based procurement of drugs and high-value medical consumables.

Han Zheng, a member of the Standing Committee of the Political Bureau of the CPC Central Committee and Vice Premier of the State Council, presided over a symposium on the centralized volume procurement of drugs and high-value medical consumables on October 10. The symposium implemented the decisions and deployments of the CPC Central Committee and the State Council, listened to the opinions of representatives from hospitals, enterprises, experts, and local medical insurance bureaus, and studied and deployed the work of centralized volume procurement of drugs and high-value medical consumables. On September 10, Han Zheng, a member of the Standing Committee of the Political Bureau of the CPC Central Committee and Vice Premier of the State Council, presided over a symposium on the centralized volume procurement of drugs and high-value medical consumables. The symposium implemented the decisions and deployments of the CPC Central Committee and the State Council, listened to the opinions of representatives from hospitals, enterprises, experts, and local medical insurance bureaus, and studied and deployed the work of centralized volume procurement of drugs and high-value medical consumables. Photo by Ding Haitao, Xinhua News Agency. Han Zheng stated that the centralized volume procurement reform has achieved significant results and played an important role in improving people's well-being, promoting the "three medical linkage" reform, and promoting the healthy development of the pharmaceutical industry. We must adhere to goal-oriented, problem-oriented, and result-oriented approaches, further build consensus, deepen reforms, and gain public trust, unswervingly pushing this work forward. Han Zheng emphasized the need to consolidate and improve institutional achievements, form a more standardized institutional system, and promote the normalized and institutionalized implementation of national organized drug procurement. We must accelerate the expansion of the procurement scope, address the problems of inconsistent and unclear classification of medical consumables, and do a solid job in the centralized volume procurement of cardiac stents. We must strengthen the quality supervision of selected products throughout their lifecycle, adopt a "zero-tolerance" policy towards quality problems, and investigate and deal with them in accordance with the law and regulations. We must procure and use selected drugs and consumables according to regulations and prevent the situation of "procurement without use". We must improve and implement supporting policies for the reform, fully mobilizing the enthusiasm of medical institutions, medical personnel, manufacturers, and patients. All regions and departments must earnestly implement the work and work together to do a good job in centralized volume procurement, continuously enhancing the sense of gain among the people. Relevant officials from the State Council attended the symposium. Officials from the National Healthcare Security Administration made a report, and representatives from Qilu Pharmaceutical Group, Lepu Medical (Beijing) Co., Ltd., Fuwai Hospital of the Chinese Academy of Medical Sciences, Peking University First Hospital, Beijing Friendship Hospital, Affiliated to Capital Medical University, and medical insurance departments in Tianjin and Anhui made speeches. Source: Xinhua Net

Seven departments jointly issued a document stating that medical consumables shall not be subject to secondary pricing.

City-level organizations, alliance procurement, platform operation, content involves high-value consumables, ordinary consumables, in-vitro diagnostic reagents, etc. 1. Group negotiations for some varieties have begun Recently, the Guangzhou Municipal Medical Security Bureau and six other departments issued a "Notice on the Implementation Plan for the Centralized Procurement of Medical Consumables in Guangzhou Medical Institutions," which covers the procurement and transaction behavior of medical consumables (including high-value medical consumables, ordinary medical consumables, and in-vitro diagnostic reagents) in medical institutions. It is understood that this plan aims to effectively reduce the inflated prices of medical consumables, guarantee clinical needs, and promote institutional and mechanism reforms in the pharmaceutical purchasing and sales field in Guangzhou. The content points out that a working mechanism for the procurement and transaction of medical consumables in Guangzhou medical institutions and a Guangzhou medical consumables procurement and transaction platform (hereinafter referred to as the Guangzhou platform) will be established; classified procurement of medical consumables will be implemented to ensure the quality and reasonable prices of medical consumables and guarantee a stable and timely supply of medical consumables; a comprehensive supervision system for medical consumables will be established and improved to standardize the procurement and transaction of medical consumables and achieve online procurement of all types of medical consumables. The centralized procurement of medical consumables in Guangzhou medical institutions will be promoted according to the principle of classification and batching. It is strived to carry out the first batch of product procurement and transaction work from November 2020, and to conduct group negotiations for some varieties. 2. Consumables with stable prices are directly listed online According to Saibai Lan Medical Device Observation, promoting classified procurement is a key emphasis in each plan. The Guangzhou platform implements direct online listing, group negotiation, and price negotiation for the procurement of medical consumables by medical institutions, and medical institutions purchase relevant products on the Guangzhou platform according to regulations. Direct online listing procurement. Nationally and provincially unified centralized procurement varieties and high-value medical consumables that have passed medical insurance access and have clear medical insurance payment standards and relatively stable prices will be implemented through direct online listing procurement. Group negotiation procurement. For some medical consumables with large clinical usage, high procurement amounts, and mature clinical use, the "city-level organization, alliance procurement, platform operation" method can be used to establish a Guangzhou medical institution procurement alliance, and group negotiation procurement can be implemented under the principle of centralized volume procurement. Explore the implementation of cross-regional joint group negotiation procurement. Price negotiation procurement. Medical institutions, in accordance with the principles of volume procurement and quantity-price linkage, combined with factors such as the quantity purchased and the repayment cycle, reasonably negotiate procurement prices with medical consumable production and operation enterprises. Encourage and support medical institutions to jointly conduct price negotiation procurement. The Guangzhou platform collects market price data for reference by medical institutions. Other procurement methods determined by national, provincial, and municipal medical security departments. 3. Establish a medical consumables procurement expert database Under the unified medical consumables coding, establishing an expert database is another highlight. On the establishment of the procurement platform, a unified medical consumables coding standard will be implemented. Implement the national unified classification and coding standards for medical consumables, establish a medical consumables coding database, and carry out dynamic maintenance. Explore and promote the application of national medical consumables coding standards in bidding, procurement, distribution, use, settlement, and supervision, and promote information interoperability between medical institutions, procurement platforms, and supervision platforms. The Guangzhou platform is responsible for the construction and operation and maintenance of the Guangzhou Public Resource Trading Center, integrating functions such as information maintenance, order distribution, contract management, procurement transactions, and settlement payments, connecting with relevant regulatory platforms, providing information release, service object inquiry, information reporting, procurement transactions, price prompts, and supervision and complaints, and continuously optimizing and improving based on actual work. The medical information management system or procurement system of medical institutions will be connected to the Guangzhou platform. At the same time, a medical consumables procurement expert database will be established. In accordance with the principles of fairness, justice, professionalism, and voluntariness, a medical consumables procurement expert database covering different professional categories such as clinical, medical insurance, and management will be established. Experts from the expert database will participate in relevant businesses such as medical consumables procurement consultation, review, and negotiation. When medical institutions jointly conduct price negotiation procurement, they can apply to randomly select experts from the expert database to represent the joint body in conducting price negotiations. 4. Cross-regional price linkage In terms of strengthening comprehensive supervision, the first is to fully implement online procurement. High-value medical consumables used by public medical institutions in Guangzhou (including provincial and ministerial public medical institutions) should be purchased through the procurement platform, and other medical consumables should be purchased through the procurement platform in principle. Other municipal public medical institutions are encouraged and supported to choose the Guangzhou platform for procurement transactions. Private medical institutions and retail pharmacies are encouraged to voluntarily participate in the centralized procurement of medical consumables in Guangzhou. Institutions participating in the centralized procurement of medical consumables in Guangzhou will sign a centralized procurement agreement for medical consumables with the medical insurance agency. In addition, the supervision and management of various parties involved, including the procurement platform, medical consumables production enterprises, distribution enterprises, and medical institutions, will be implemented, and information will be interconnected with medical security, health and health, market supervision, and price monitoring departments to achieve comprehensive supervision. At the same time, the intensity of quality inspections of purchased medical consumables will be increased, quality supervision will be strengthened, monitoring of adverse events of purchased medical consumables will be strengthened, and quality safety will be ensured. A price prompt system for the procurement of medical consumables by medical institutions will be established to promote the reasonable formation of medical consumables prices. A cross-regional linkage mechanism for medical consumables prices will be studied and established, and information interoperability will be achieved with medical consumables procurement and transaction platforms with cooperative relationships. Regulate the circulation and distribution links. Increase the efforts to crack down on tax-related illegal and criminal acts such as issuing false invoices, regulate the distribution of medical consumables, and ensure that the supply of medical consumables is timely and sufficient. Public medical institutions should establish a selection mechanism for the distribution of high-value medical consumables to promote fair market competition. Medical consumables production enterprises are the main body responsible for supply and distribution, guaranteeing the right of medical consumables production enterprises to independently choose distribution enterprises, and guiding medical consumables production enterprises and medical institutions to reasonably choose distribution enterprises. Medical institutions should settle payments in a timely manner in accordance with the contract. Gradually promote online settlement of procurement transactions on the Guangzhou platform by medical institutions. 5. Medical institutions and enterprises shall not re-negotiate prices In terms of procurement supervision mechanisms, the internal management system for the procurement of medical consumables by medical institutions will be standardized, and the procurement situation on the procurement platform, the implementation of the procurement volume, and the implementation of the repayment will be included as the content of the comprehensive reform assessment of public medical institutions, and included in the target management and medical institution evaluation work. Establish an in-hospital access selection mechanism for high-value medical consumables, and strictly prohibit departments from purchasing on their own. For varieties that have passed national, provincial, and municipal centralized volume procurement or group negotiations, medical institutions and enterprises shall not re-negotiate prices. Strictly implement the relevant regulations on备案采购. Comprehensive use of various regulatory measures. Strengthen the management of the procurement situation of key monitoring varieties. Improve the agreement management of medical insurance designated medical institutions, include the procurement situation of medical consumables in medical insurance assessment, and link it with the hierarchical management of designated medical institutions, medical insurance settlement and payment, etc. A scientific and reasonable assessment and management system will be established to regulate the procurement and transaction behavior of medical consumables by medical consumables production and operation enterprises. Strictly implement the system of credit information recording, dishonesty punishment, market exit, and market prohibition, and relevant information will be promptly announced to the public. The Guangzhou platform will record credit information for each procurement transaction entity; for illegal and irregular acts in the procurement and transaction of medical consumables and other dishonest acts applicable to joint punishment, measures such as restricting participation in centralized procurement will be taken in accordance with the law and regulations to constrain or punish them. 6. Time arrangement announced The content points out that this implementation plan will be implemented from the date of issuance and will be valid for 5 years. Disclaimer: The above content is reproduced from Saibai Lan Medical Device, and the published content does not represent the position of this platform.

Authoritative Release! 41 Hospitals in Henan Province Reported, 69 Enterprises Rectified

Recently, the official website of the Henan Provincial Drug Supervision and Administration Bureau announced a notice on the rectification of medical device inspections in the second half of 2019, involving medical device business enterprises and user units. 41 hospitals were rectified, with ultrasound machines and respirators being the focus of the inspection. The full text is as follows: Notice of the Henan Provincial Drug Supervision and Administration Bureau on the Rectification of the Flight Inspection of Medical Device User Units in the Second Half of 2019 In the second half of 2019, in accordance with the "Methods for Flight Inspection of Drugs and Medical Devices", the Henan Provincial Drug Supervision and Administration Bureau organized a total of 41 medical device user units for flight inspections. Focusing on high-value medical consumables, sterile and implantable devices, in vitro diagnostic reagents, sodium hyaluronate for injection, customized dentures, color ultrasound diagnostic instruments, perfluoropropane gas, infant incubators, respirators and other key products, a check plan was formulated, and in accordance with the requirements of the "Methods for Quality Supervision and Management of Medical Device Use", etc., the key inspection focused on the implementation of the main responsibilities for the quality and safety of medical device use by user units, and the quality and safety management of medical device use. A comprehensive inspection was carried out on key links such as procurement, acceptance, storage, use, maintenance, and adverse event monitoring. The inspection found that user units had varying degrees of problems such as imperfect medical device quality management systems, inadequate implementation, non-strict procurement and acceptance management, and non-standard document records. Regarding the problems and clues found during the inspection, the inspection team has transferred them to the regulatory departments in the location of the medical device user units for investigation and handling in accordance with relevant regulations such as the "Regulations on the Supervision and Administration of Medical Devices", the "Methods for Monitoring and Re-evaluation of Adverse Events of Medical Devices", and the "Methods for Quality Supervision and Management of Medical Device Use". At the same time, user units were urged to rectify the existing problems. The rectification of the flight inspection of medical device user units in the second half of 2019 (see attachment) is hereby announced. Notice of the Henan Provincial Drug Supervision and Administration Bureau on the Rectification of the Flight Inspection of Medical Device Business Enterprises in the Second Half of 2019 In the second half of 2019, in accordance with the "Methods for Flight Inspection of Drugs and Medical Devices", the Henan Provincial Drug Supervision and Administration Bureau organized a total of 19 medical device business enterprises for flight inspections. In accordance with the "Specifications for Quality Management of Medical Device Operation" and supporting regulatory documents, the key inspection focused on the implementation of the main responsibilities for quality and safety by enterprises, and the quality and safety management of products. A comprehensive inspection was carried out on key links such as procurement, acceptance, storage, sales, and product traceability. The inspection found that some enterprises had problems such as imperfect medical device quality management systems, non-strict procurement and acceptance management, and non-standard document records. Regarding the problems and clues found during the inspection, the inspection team has transferred them to the regulatory departments in the location of the medical device business enterprises for investigation and handling in accordance with relevant regulations such as the "Regulations on the Supervision and Administration of Medical Devices", the "Methods for Supervision and Administration of Medical Device Operation", and the "Specifications for Quality Management of Medical Device Operation". At the same time, enterprises were urged to rectify the existing problems. The rectification of the flight inspection of medical device business enterprises in the second half of 2019 (see attachment) is hereby announced. Source: Henan Traffic Broadcasting 1041

The General Office of the State Council issued the Guiding Opinions on Promoting the Reform of the Medical Security Fund Supervision System.

The State Council recently issued the "Guiding Opinions on Promoting the Reform of the Medical Insurance Fund Supervision System" (hereinafter referred to as the "Opinions"). The Opinions implement the Party Central Committee and the State Council's requirements on strengthening the supervision of medical insurance funds, comprehensively improving the governance capacity of medical insurance, deeply purifying the operating environment of the system, and strictly guarding the safety red line of the funds. The Opinions point out that medical insurance funds are the "money for seeing a doctor" and "life-saving money" of the people. Since the establishment of the basic medical insurance system, the coverage has continued to expand and the level of protection has gradually improved. It has played a positive role in safeguarding the health rights and interests of the people, alleviating poverty caused by illness, and promoting reforms in the medical and health system. However, due to factors such as the imperfect supervision system and the imperfect incentive and restraint mechanisms, the efficiency of medical insurance fund use is not high, and the situation of fund supervision is quite severe. The Opinions emphasize that we should be guided by Xi Jinping's Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the second, third, and fourth plenary sessions of the 19th Central Committee, and accelerate the reform of the medical insurance fund supervision system. By 2025, a medical insurance fund supervision system and law enforcement system will be basically established, forming an all-round supervision pattern based on the rule of law, credit management, multi-form inspections, big data supervision, combined with Party leadership, government supervision, social supervision, industry self-discipline, and individual integrity, realizing the legalization, professionalization, standardization, and normalization of medical insurance fund supervision, and continuously developing and improving it in practice. The Opinions require clarifying supervisory responsibilities. Strengthen Party leadership and continuously improve the leadership system and working mechanism for Party building in medical insurance fund supervision. Strengthen government supervision and give full play to the government's leading role in the rule of law construction, standard setting, law enforcement, and information sharing of fund supervision. Promote industry self-regulation management, guide and support medical and health industry organizations to play a better role in promoting industry self-discipline. The Opinions propose promoting the reform of the supervision system. Establish and improve supervision and inspection systems, comprehensively establish intelligent monitoring systems, establish and improve reporting and reward systems, establish credit management systems, establish comprehensive supervision systems, and improve social supervision systems. The Opinions emphasize improving supporting measures. Strengthen the legal and regulatory guarantees for medical insurance fund supervision, strengthen the capacity building for medical insurance fund supervision and inspection, increase the punishment of fraudulent insurance behavior, comprehensively promote related medical insurance system reforms, and jointly promote reforms in the medical service system. The Opinions require that local governments at all levels should fully understand the importance of promoting the reform of the medical insurance fund supervision system, strengthen leadership, unified deployment, and coordinated promotion. An incentive and accountability mechanism should be established, and the work of combating fraud and insurance fraud should be included in the relevant work assessment. We should vigorously publicize the importance of strengthening the supervision of medical insurance funds, actively respond to social concerns, and strive to create a good atmosphere for reform. Source: Xinhua News Agency

Industry Favorable News! The MAH system for medical devices is implemented nationwide.

On July 7, the State Council issued the "Notice on Doing a Good Job in Copying and Promoting the Experience of the Sixth Batch of Reform Pilot Projects in Free Trade Zones". The Notice points out that the local governments and relevant departments where the free trade zones are located, combining their respective functional positioning and characteristics of the free trade zones, have made every effort to promote institutional innovation and practice, forming the sixth batch of reform pilot experience of the free trade zones, which will be copied and promoted nationwide. Article 36 mentions the entrusted production model for medical device registrants. In addition to producing products themselves, medical device registrants can entrust enterprises with the corresponding production conditions to produce products. The responsible unit for the entrusted production model for medical device registrants is the National Medical Products Administration, and the promotion scope is nationwide. This will undoubtedly bring benefits to the medical device industry. Medical Device MAH is Considered a Disruptive Reform in the Industry The medical device registrant system, namely the marketing authorization holder system in the medical device field. Under this system, qualified medical device registration applicants can apply for medical device registration certificates independently, and then entrust qualified and capable enterprises to produce them, thus realizing the "unbundling" of medical device product registration and production licenses. Previously, China's medical device industry implemented a "bundled" model of product registration and production licenses, requiring registrants to set up their own factories to produce products. If they wanted to entrust production, both parties must have both the medical device registration certificate and the production license. This not only increased the cost for enterprises and prolonged the product launch time, but also hindered enterprise innovation, especially for small and micro-enterprises with R&D capabilities. On the one hand, production control capabilities cannot be formed overnight, and on the other hand, the huge investment in medical device production is difficult to bear. Therefore, the "medical device registrant system" is also considered a disruptive reform in the industry. According to Huo Shi Chuangzao, there are a total of 45,403 medical device-related enterprises in China, including 16,000 production enterprises, of which more than 90% are small and medium-sized enterprises. Less than 10% are large-scale enterprises, and less than 400 have an annual output value exceeding 100 million yuan. Most enterprises have low technical content, among which there are 16,035 enterprises related to surgical instruments. The introduction of medical device MAH can effectively solve the difficulties faced by start-up enterprises in their early stages, such as limited funds, compliance, and lack of production personnel, allowing innovative enterprises and R&D enterprises to focus on product R&D, opening up the production link to professional service enterprises, strengthening innovation while reducing enterprise costs. According to statistics, enterprises that use outsourcing to produce Class II medical devices can save nearly 10 million yuan in three years and significantly reduce the product launch cycle. According to Yuanxin Medical's electrocardiograph, the first medical device product to use MAH, it shows that it took only 26 working days from formal acceptance to approval for listing, which is 82% shorter than the statutory time limit. In recent years, the domestic medical device market has developed rapidly, from 114.1 billion yuan in 2010 to 370 billion yuan in 2016, 448 billion yuan in 2017, and exceeding 500 billion yuan in 2018, with an annual growth rate exceeding 20%. Key development areas of medical devices, such as diagnostic reagents, imaging equipment, and high-value consumables, are becoming rapidly developing industrial sectors in various regions. Against this backdrop, the medical device MAH system will continue to deepen. Review of Relevant Policies on Medical Device MAH In 2016, the marketing authorization holder system for pharmaceuticals was launched. At the end of 2017, the medical device MAH was piloted in Shanghai, and in May 2018, it was expanded to Guangdong and Tianjin. In the beginning of 2019, the Beijing-Tianjin-Hebei region was included in the pilot area. The introduction of MAH brings new opportunities and challenges to enterprises and government work. In 2016, China began piloting the marketing authorization holder system for pharmaceuticals in ten provinces and municipalities, including Shanghai, Jiangsu, and Beijing, allowing marketing authorization holders for pharmaceuticals to entrust production. On December 7, 2017, the "Implementation Plan for the Pilot Program of the Medical Device Registrant System within the China (Shanghai) Pilot Free Trade Zone" was issued and implemented by the Shanghai Food and Drug Administration. The Shanghai Free Trade Zone took the lead in piloting the medical device marketing authorization holder system (MAH), allowing qualified medical device registration applicants within the free trade zone to apply for medical device registration certificates independently and then entrust qualified and capable production enterprises to produce them. On July 5, 2018, the Shanghai Municipal Drug Administration issued an announcement "expanding the pilot reform of the medical device registrant system to the entire city", allowing medical device registration applicants within Shanghai to entrust Shanghai medical device production enterprises to produce products. On January 9, 2018, the State Food and Drug Administration issued the "Announcement on the Pilot Program of the Medical Device Registrant System by the Shanghai Municipal Food and Drug Administration (No. 1 of 2018)". On May 24, 2018, the State Council issued the "Further Deepening Reform and Opening-up Plan for the China (Guangdong), (Tianjin), and (Fujian) Pilot Free Trade Zones", clarifying that the medical device registrant system reform has been approved to be expanded from Shanghai to Guangdong and Tianjin. The scope of the "separation of licenses and certificates" pilot program has been further expanded. On July 5, 2018, the Shanghai Municipal Food and Drug Administration issued the "Announcement on Expanding the Pilot Reform of the Medical Device Registrant System to the Entire City", deciding to expand the pilot program to the entire Shanghai city. In October 2018, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. was awarded the first Class II medical device product registration certificate after the implementation of the Guangdong Provincial Medical Device Registrant System. The company's injection pump became the first medical device product approved for listing under the "Guangdong Provincial Medical Device Registrant System Pilot Program". On February 22, 2019, the Chinese Government website issued the "Reply on the Comprehensive Pilot Program for Expanding the Opening-up of the Service Industry in Beijing", agreeing to continue and comprehensively promote the comprehensive pilot program for expanding the opening-up of the service industry in Beijing for a period of three years from the date of approval. It proposes to allow Beijing medical device registrants to entrust medical device production enterprises in the Beijing-Tianjin-Hebei region to produce medical devices, exploring for the first time the cross-regional industrial chain development of "registration + production". In August 2019, the National Medical Products Administration issued the "Notice on Expanding the Pilot Program of the Medical Device Registrant System", further expanding the pilot program of the medical device registrant system. The Notice clarifies that the medical device registrant system will be piloted in 21 provinces, autonomous regions, and municipalities directly under the Central Government, including Shanghai, Tianjin, and Guangdong. These other provinces and cities also include Beijing, Hebei, Liaoning, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, and Shandong. On December 29, 2019, the drug regulatory authorities of Shanghai, Jiangsu, Zhejiang, and Anhui jointly issued the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in the Yangtze River Delta Region", allowing medical device registration applicants in the Yangtze River Delta region to entrust production enterprises in the Yangtze River Delta region to produce products. This means that the pilot program of the medical device registrant system will realize cross-regional entrustment in the above four provinces and cities. Entrusted production of medical devices refers to medical devices classified as Class II or Class III according to the medical device classification rules (including innovative medical devices and samples), excluding Class I medical devices. Products that are included in the catalog of medical devices prohibited from entrusted production issued by the former State Food and Drug Administration are generally not included in the pilot program.

Major News! Medical Consumables Coding Officially Begins!

Preface On June 28, the National Healthcare Security Administration (NHSA) released the "Update of the Classification and Code Database for Medical Insurance Medical Consumables" (June 2020). It is understood that this update includes a total of 32,554 medical insurance medical consumable codes, covering 9,404,543 actual specifications of medical consumables. The NHSA pointed out that in accordance with the overall requirements of "unified classification, unified coding, unified maintenance, unified release, and unified management", it will accelerate the promotion of unified medical insurance information business coding standards to form a national "common language". I. 32,554 consumables have been coded Medical consumable information will be included in the national medical insurance medical consumable classification and code database for use by medical security departments across the country. In the "Notice of the National Healthcare Security Administration on Issuing Guiding Opinions on the Standardization of Medical Security Work", it is pointed out that by 2020, based on the construction of a unified national medical insurance information system, the implementation of 15 information business coding standards, including disease diagnosis and surgical operations, will be gradually realized. Finally, a top-down, unified and standardized medical insurance information business coding system will be formed. II. Interpretation of consumable coding published The coding that affects medical consumables nationwide is now available for query in the database released today. By clicking on the details, you can see more specific information. So what do all these numbers represent? The NHSA, in the "Coding Rules and Methods for Medical Insurance Disease Diagnosis and Surgical Operations, Drugs, Medical Service Items, and Medical Consumables", demonstrates the coding of medical insurance medical consumables: (Image source: National Healthcare Security Administration) Interpretation: The medical insurance medical consumable code is divided into five parts with a total of 20 digits, represented by uppercase English letters and Arabic numerals arranged in a specific order. The first part is the consumable identifier, the second part is the classification code, the third part is the generic name code, the fourth part is the product characteristic code, and the fifth part is the manufacturer code. Part 1: Consumable identifier, represented by the uppercase English letter "C". Part 2: Classification code, divided according to the discipline, use, location, and function of the medical consumable, represented by 6 Arabic numerals. Part 3: Generic name code, creating a nationally unified generic name code for medical insurance medical consumables, represented by 3 Arabic numerals. Part 4: Product characteristic code, a code assigned according to the material, specifications, and other characteristics of the consumable, represented by 5 Arabic numerals. Part 5: Manufacturer code, a unique code assigned to the consumable manufacturer based on the medical device registration certificate or filing certificate, represented by 5 Arabic numerals. This update includes a total of 32,554 medical insurance medical consumable codes, covering 9,404,543 actual specifications of medical consumables. III. Local medical insurance departments must not adjust arbitrarily On June 8, the NHSA released the "Interim Measures for the Management of Medical Consumables under Basic Medical Insurance (Draft for Comments)", which mainly includes two parts: examples and catalogs. The examples are explanations and descriptions of the arrangement format, name and coding standards, and payment scope of the "Basic Medical Insurance Medical Consumable Catalog". The catalog includes the number, functional classification, medical insurance code, payment scope, pricing unit, payment standard, method for determining the payment standard, and remarks. The "Draft for Comments" emphasizes that, except as otherwise specifically provided, local medical insurance departments shall uniformly implement the national "Basic Medical Insurance Medical Consumable Catalog" and shall not adjust it arbitrarily. It is understood that the medical consumables referred to in these measures are medical consumables that have been approved by the drug supervision and administration department, can be charged separately, and have a unified coding for medical insurance medical consumables. The medical insurance access, payment, and corresponding management and supervision of medical consumables shall apply to these measures. According to the "Draft for Comments", medical insurance funds will not be paid for medical consumables in the catalog under any of the following circumstances: 1. Used for non-disease diagnosis and treatment projects; 2. Used for various research and clinical verification diagnosis and treatment projects; 3. Exceeding the reasonable scope of use; 4. Other circumstances that do not comply with the payment scope of basic medical insurance. Medical insurance funds and patients will not be paid for medical consumables in the catalog under any of the following circumstances: 1. Unsuccessful use due to the consumable itself; 2. Implantable consumable costs exceeding the actual number implanted. Medical consumables in the "Basic Medical Insurance Medical Consumable Catalog" must meet the following conditions simultaneously for medical insurance funds to be paid: 1. For the purpose of disease diagnosis and treatment; 2. Comply with the scope of application registered or filed with the drug supervision and administration department; 3. Comply with the payment scope specified in the "Basic Medical Insurance Medical Consumable Catalog"; 4. Prescribed by medical personnel with the corresponding qualifications from designated medical institutions (emergency rescue can be appropriately relaxed to non-designated medical institutions); 5. Other conditions stipulated by the state. IV. Consumable coding involves payment and settlement It can be seen that the coding work for medical consumables, which has been a focus of attention in the medical field, has officially begun. By 2020, based on the construction of a unified national medical security information system, the implementation of 15 information business coding standards, including disease diagnosis and surgical operations, will be gradually realized. Unlike drugs, consumables are not only numerous and diverse, but the names of the same product are different in different regions during bidding and procurement, and the policies and regulations on consumables vary from place to place, causing many inconveniences in the bidding, procurement, and payment stages. Under such circumstances, some enterprises have taken advantage of this to evade price supervision, and some regions have even formed mixed business models. One of the purposes of the consumable procurement alliance that has emerged in recent years is to implement practices such as sharing consumable procurement prices and data to avoid this practice by enterprises. The emergence of medical consumable coding standards will inevitably change and correct certain aspects of the consumable industry chain to cooperate with the medical insurance disease diagnosis and surgical operation information business coding standards that have also been a key focus in the early stages. In fact, due to the lack of unified standards, enterprises themselves often do not know the names and information of their products in bidding and procurement in multiple places. For example, the product name is "a" in Beijing, but it becomes "b" in Nanjing. Conclusion This "consensus" will directly affect the bidding, procurement, and payment stages of consumables. In the past, consumables were complex, but with coding standards, the chaotic situation will change, eliminating the problems caused by information differences in the bidding and procurement stages, and thus affecting the payment stage. Source: Saibo Blue Medical Devices

Expert Interpretation: From "Blacklist" to "Whitelist": China's Medical Consumables Enter a New Stage of Access Management

On June 8, 2020, China's National Healthcare Security Administration issued the "Draft Interim Measures for the Management of Medical Consumables under the Basic Medical Insurance System" (hereinafter referred to as the "Draft Interim Measures") for public comment.

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