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.

Yesterday, 31 provinces, autonomous regions, and municipalities reported 47 new imported cases.

From 0:00 to 24:00 on March 24, 31 provinces (autonomous regions, municipalities) and the Xinjiang Production and Construction Corps reported 47 new confirmed cases, all of which were imported from overseas; 4 new deaths were reported; 33 new suspected cases were reported, all of which were imported from overseas. On the same day, 491 new cases were cured and discharged from hospitals, 1,215 close contacts were released from medical observation, and serious cases decreased by 174. As of 24:00 on March 24, according to reports from 31 provinces (autonomous regions, municipalities) and the Xinjiang Production and Construction Corps, there were 4,287 existing confirmed cases (including 1,399 serious cases), 73,650 cumulative cured and discharged cases, 3,281 cumulative deaths, 81,218 cumulative reported confirmed cases, and 134 existing suspected cases. A total of 693,223 close contacts were traced, and 13,356 close contacts were still under medical observation. Hubei reported 0 new confirmed cases (Wuhan 0 cases), 487 new cured and discharged cases (Wuhan 472 cases), 3 new deaths (Wuhan 2 cases), 3,828 existing confirmed cases (Wuhan 3,794 cases), of which 1,368 were serious cases (Wuhan 1,358 cases). A cumulative total of 60,810 cases were cured and discharged (Wuhan 43,686 cases), 3,163 cumulative deaths (Wuhan 2,526 cases), and 67,801 cumulative confirmed cases (Wuhan 50,006 cases). There were 0 new suspected cases (Wuhan 0 cases), and 0 existing suspected cases (Wuhan 0 cases). From 0:00 to 24:00 on March 24, 47 new imported confirmed cases were reported (Shanghai 19 cases, Beijing 5 cases, Guangdong 5 cases, Tianjin 4 cases, Fujian 4 cases, Inner Mongolia 2 cases, Jiangsu 2 cases, Sichuan 2 cases, Jilin 1 case, Zhejiang 1 case, Shandong 1 case, Shaanxi 1 case). As of 24:00 on March 24, a cumulative total of 474 imported confirmed cases had been reported.

In the fight against the epidemic, SAMR is taking action | Henan Provincial Drug Administration ensures the supply and quality of epidemic prevention drugs and medical devices

Recently, the Henan Provincial Drug Administration formed an inspection and guidance team, led by relevant persons in charge and consisting of staff from the Provincial Drug Administration's Administrative Licensing Department, Device Registration Department, and the Provincial Food and Drug Review and Inspection Center, to solidly carry out approval guidance for medical devices for epidemic prevention and control.

Henan Provincial Drug Administration launches epidemic prevention and control action

On February 1, reporters learned from the Henan Provincial Medical Products Administration that in recent days, the administration has prioritized epidemic prevention and control as the most important task, understanding, undertaking, and fulfilling responsibilities, implementing details thoroughly, and fully launched epidemic prevention and control actions.