Source of this article: Times Business School Author: Huang Youqian Source | Times Business School Author | Huang Youqian Editor | Li Qiantao Macro Situation According to data from the National Bureau of Statistics, in April, the health care CPI (resident consumer price index) ge

Source of this article: Times Business School Author: Huang Youqian

Source | Times Business School

Author | Huang Youqian

Editor | Li Qiantao

Macausage

According to data from the National Bureau of Statistics, in April, the health care CPI (resident consumer price index) was generally running smoothly, with a slight increase of 0.7% year-on-year. Among them, rural areas rose by 0.8% year-on-year, and cities rose by 0.6% year-on-year.

In terms of import and export of medical devices, data from the General Administration of Customs showed that in April, the domestic export of medical instruments and devices was US$1.445 billion, a year-on-year decrease of 10.19% and a month-on-month decrease of 7.17%; this year, the cumulative value of domestic medical instruments and devices exports was US$5.971 billion, a year-on-year increase of 1.25%.

During the same period, the total amount of domestic medical instruments and equipment imports was US$1.035 billion, a year-on-year decrease of 16.31% and a month-on-month decrease of 22.12%; this year, the cumulative value of domestic medical instruments and equipment imports was US$4.496 billion, a year-on-year decrease of 5.8%.

Market performance

5, the Shanghai Composite Index (000001.SH) rose 4.57%, up 10.88 percentage points from the decline of April-6.31%; the Shenzhen Component Index (399001.SZ) rose 0.23%, up 9.28 percentage points from the decline of April-9.05%; the Shanghai and Shenzhen 300 Index (000300.SH) fell 0.15%, narrowing the decline of April (-4.89%).

According to Shenwan second-level classification, medical devices (801153.SI) has risen by 2.61%, up from April (-10.92%), underperforming the Shanghai Composite Index by 1.96 percentage points, outperforming the Shenzhen Component Index by 2.38 percentage points, and the Shanghai and Shenzhen 300 Index by 2.76 percentage points.

Specifically, in May, the average increase of 107 listed companies in A-share medical devices was 4.81%, and the median was 4.63%, which significantly increased compared with April (average -18.74%, median -21.33%). Among them, the range of 81 companies increased positively, accounting for 75.7%. Among the top five companies in

107, the top five in stock price increase were ST Hejia (300273.SZ), Sannuo Bio (300298.SZ), Tianyi Medical (301097.SZ), Zhijiang Bio (688317.SH), and OpcomShi (300595.SZ), with cumulative increases in May were 34.84%, 33.83%, 31.17%, 26.97%, and 25.09%, respectively.

It is worth mentioning that Opcom's range gained 1.12% in April, ranking eighth in that month. Except for OPCV, which had a positive increase in April, the stock prices of the other top five were all negative in April. Among them, ST Hejia's range change in April was -69.25%, ranking last. Tianyi Medical ranked fourth from the bottom with a range of -39.21%, and its ranking increased significantly this month, becoming the third place in the line.

It can be seen that the above-mentioned companies were sought after by investors in May and their stock prices rose significantly.

5 In May, Furui Co., Ltd. (300049.SZ), Jiuan Medical (002432.SZ), Wantai Bio (603392.SH), Mingde Bio (002932.SZ), and Anxu Bio (688075.SH) suffered a large monthly decline, ranking among the top five in the medical device industry, with cumulative declines of -31.37%, -26.59%, -21.07%, -17%, and -14.61%, respectively.

Among them, Furui Co., Ltd., Mingde Biology and Jiuan Medical ranked first, third and sixth with a range of 37.68%, 16.05% and 6.58% respectively in April. In May, the above three companies fell significantly in the range, ranking last, fourth and second to last respectively.

In addition, Anxu Bio's stock price fell by 34.56% in April, ranking eighth to the bottom in the month; in May, the company's stock price continued to fall, with a cumulative range decline of -14.61%, ranking fifth to the bottom. As of May 31, the company's closing price was 157.6 yuan per share, down 44.12% from its stock price on April 1, far exceeding the industry's cumulative decline of -14.14%.

Industry policy news

1. [China Medical Device Industry Development Report Conference was held]

On May 26, the China Medical Device Industry Development Report Conference and the medical device "Medical and Industrial Interaction·Medical Transformation" seminar hosted by the Southern Medical Economics Research Institute of the State Food and Drug Administration were held online. Xu Jinghe, deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

Xu Jinghe pointed out that at present, my country's medical device industry has entered a golden period of development, the reform and innovation of the review and approval system has entered a period of in-depth advancement, the construction of regulatory capacity has entered a period of comprehensive strengthening, and quality supervision has entered a period of high-risk risk. We must scientifically plan future development, adhere to the lofty mission of medical device supervision, adhere to the grand goal of achieving a strong country in equipment manufacturing, adhere to the development path of a strong country in medical device, adhere to the basic principles of medical device supervision, and grasp the theme of the times of medical device supervision.

Xu Jinghe put forward five requirements for key medical device supervision: 1. Reform should be deepened, the optimization of review and approval process should be promoted, the technical guidance principle system should be improved, the construction of review and inspection sub-centers should be strengthened, and the high-quality development of the industry should be encouraged and supported.

2. Supervision should be strengthened. After listing, supervision will further enhance the targetedness, pertinence and effectiveness of supervision, and upgrade traditional supervision methods to further improve supervision efficiency.

3. We must take a heavy blow to rectify the problem. We must crack down on unlicensed production, registration and fraud in the development and production of medical devices, and crack down on unlicensed operations and illegal online sales in the operation and use process, so as to effectively safeguard the lives and health of the people.

4. Capacity must be strengthened, and scientific research and intelligent supervision must be continuously promoted, basic theoretical research on medical device supervision must be strengthened, and basic theoretical research on medical device supervision must be continuously improved. In addition, it is necessary to strengthen the supervision of medical devices for epidemic prevention and control. (China Food and Drug Network)

2. [The State Food and Drug Administration held a report meeting on the implementation of the "Regulations on Medical Device Supervision and Administration"]

On May 31, the State Food and Drug Administration held a report meeting on the implementation of the "Regulations on Medical Device Supervision and Administration". The report meeting summarized the achievements of the Regulations since the first anniversary of the implementation of the Regulations, exchanged and shared work experience, guided and promoted the further study and implementation of the Regulations in the entire system and the entire industry, comprehensively strengthened the supervision of medical device production and operation, and ensured the safety of public equipment. Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, attended the meeting and delivered a speech.

meeting pointed out that the Regulations fully implement the requirements of "four strictest", consolidate the results of reform and innovation in the form of laws and regulations, strengthen quality management throughout the life cycle, and further promote the high-quality development of industrial innovation and development, marking that my country's medical device industry has entered a new stage of rule of law.

In the past year of implementation of the Regulations, various supporting regulations and normative documents have been issued one after another, effectively ensuring the full implementation of the Regulations. The entire system and the entire industry will study the "Regulations" in depth through multiple methods and channels, and actively promote the implementation and effectiveness of new regulations.

In the past year of the implementation of the Regulations, the dividends of regulatory policies have been continuously released, continuously stimulating the growth potential of the medical device industry and promoting the innovative development and high-quality development of the medical device industry. The entire system will comprehensively strengthen the quality supervision of medical devices throughout the life cycle, carry out in-depth investigation and rectification of risks and hidden dangers, and product quality will be stable and improving. (State Medical Products Administration)

3. [Empowering the medical device industry toward the high-end global value chain]

On June 1, the unveiling ceremony of the National High-Performance Medical Device Innovation Center (hereinafter referred to as "Guo Chuang Center") technical service base and animal experimental base were held at Shenzhen Drug Inspection Institute (hereinafter referred to as "Shenzhen Drug Inspection Institute").

, the National Innovation Center, which was launched in Longhua in April 2020, is Shenzhen's first national-level manufacturing innovation center and the only innovation center established by the country in the field of medical devices. It has built a common technology research and development platform with a site size of 20,000 square meters and a equipment value of more than 200 million yuan in Longhua, and is committed to breaking through the common core key technologies in the development of the high-end medical device industry.

Shenzhen Pharmaceutical Inspection Institute is the largest one-stop technical service platform for animal experiments and medical device innovative products in the Guangdong-Hong Kong-Macao Greater Bay Area. Its medical device testing capabilities cover nearly 90% of the products of more than 1,200 manufacturers in the city. Its inspection and testing software and hardware conditions and comprehensive strength rank among the forefront of the national drug testing system.

National Innovation Center will focus on the development needs of the high-performance medical device industry, give full play to the advantages of carrier resources, innovate market models, and jointly establish a public service platform for the Guangdong-Hong Kong-Macao Greater Bay Area. It will provide professional and comprehensive technical services for enterprises in the areas of new product research and development, inspection and testing, preclinical evaluation, standard formulation, system construction, technical training and open sharing of equipment. (Sina.com)

4. [Summary of results for medical device classification definition in 2020-2021]

On May 19, the China Food and Drug Inspection Institute issued the "Summary of results for medical device classification definition in 2020-2021".

The total of 1,077 medical device product classification definition results from July 2020 to December 2021 summarized this time, of which 155 products are recommended to be managed according to Class III medical devices, 505 products are recommended to be managed according to Class II medical devices, 143 products are recommended to be managed according to Class I medical devices, 51 products are recommended not to be managed separately, 197 products are recommended not to be managed as medical devices, 20 products are recommended to be defined according to the drug and device combination product judgment procedure, and 6 products are recommended to be determined according to the specific situation.

Recommended that products managed according to Class III medical devices mainly include 155 items including absorbable tissue sealing membranes, medical temperature-sensitive hydroxybutyl glycan joint cavity injection, disposable endoscopic suture system, arterial thrombosis balloon catheter, disposable temperature measurement central venous catheter kit, electric sampling navigation system, etc.

Recommended products managed according to Class II medical devices include disposable ex vivo lung storage containers, valve pressure grips, disposable fat separation filters, fiber scanning probe guides, temporomandibular arthroscopic assisted surgical stapling device packages, etc.

Recommended that products managed according to Class I medical devices mainly include nasal guides, intrabronchial flap loaders, mandibular joint surgery pull rings, skull positioning nails, and surgical power handle connecting cannulas, etc. (China Food and Drug Assay Research Institute)

5. [5 innovative medical device products including the thoracic aortic stent system were approved for the market]

5 In May, the State Food and Drug Administration approved a total of 5 innovative medical device products, namely the transcatheter implantable wireless pacing system, intravascular imaging equipment, disposable intravascular imaging catheter, patient program-controlled charger, and thoracic aortic stent system. As of May 31 this year, my country has approved 160 innovative medical devices, of which 26 are newly approved this year.

The above five newly approved innovative medical devices have 3 manufacturers from Beijing, and the other 2 manufacturers are from Hangzhou and the United States. (State Medical Administration)

6. [Shanghai recovers! Medical device industry recovery]

From June 1, Shanghai will fully restore production and living order in the city, cancel the white list restrictions on resumption of work and production, and accelerate the full resumption of work and production.

Shanghai, as one of the major biopharmaceutical industries in the country, plays an important role in the entire industrial chain. With the smooth progress of resumption of work and production, the upstream and downstream affected in the past few months have begun to gradually recover, and the pharmaceutical industry may also usher in a reversal opportunity.

During the resumption of work and production, the medical device industry, which is progressing smoothly, has a clear domestic substitution effect in the industry with the advancement of technology and the emergence of localization advantages, and is expected to usher in a wave of domesticization.

According to previous news from the Pudong New Area Science and Technology Economic Commission, Xinwei Medical has recovered 80% of its production capacity, and the recovery speed is relatively fast. As the current leader in the field of neurointrusion and cardiac intervention in China, Xinwei Medical is expected to recover quickly from the impact of the epidemic in the short term. In addition, the infringement claim filed by Medtronic was also rejected by the court, which shows Xinwei's independent innovative technology advantages. The company is expected to seize the opportunity of commercialization of domestic medical devices in the long term and usher in long-term resonance. (Glonghui)

7. [6 false advertisements for myopia prevention and control have been exposed]

"Reversal of true myopia" "Magic glasses can control myopia"... At present, some false and illegal advertisements in the field of myopia prevention and control of children and adolescents on the market have seriously misled children and adolescents and parents and threatened the vision health of children and adolescents. On May 31, the State Administration for Market Regulation exposed 6 typical cases.

Qingjie Optical Technology (Shanghai) Co., Ltd. publishes advertisements containing content such as "real myopia reversal... take off glasses" in many communities, subway stations and other areas; and publishes advertisements containing content such as "one reversal, complete recovery" on its company website and WeChat official account. The Xuhui District Market Supervision Bureau of Shanghai found that it was found that it was necessary to judge that myopia required professional medical optometry. The parties did not use any optometry equipment and only recorded the customer's vision through the vision chart, and claimed that the effect of reversing myopia and taking off glasses could be achieved. The above-mentioned behavior of the parties violated the relevant provisions of the Advertising Law and was fined RMB 1.52 million in accordance with the law.

Guangzhou Aier Eye Hospital Co., Ltd. was fined 280,000 yuan in accordance with the law when publishing illegal advertisements without indicating the patent number and type; Guangzhou Chen Jinji Biotechnology Co., Ltd. claimed in the advertisement without obtaining a patent, and was fined 220,000 yuan in violation of the Advertising Law.

In addition, it also includes the advertisements released by Jin Yongkang Optometry Shop, Jiguan District, Jixi City, Heilongjiang Province, involving myopia treatment functions and are confused with medical terms; Beijing Yuqing Pharmaceutical Technology Co., Ltd. does not have a drug registration certificate but uses medical terms; Chengdu Yi Vision Optics Technology Co., Ltd. expresses assertions or guarantees of efficacy and safety, and is fined 200,000 yuan, 100,000 yuan and 70,000 yuan in accordance with the law, violating the Advertising Law. (China Radio Network)

8. [Notice of the Comprehensive Department of the State Food and Drug Administration on Comprehensive Strengthening the Consultation on the Quality and Safety Risk of Medical Devices]

On May 27, in order to fully implement the "Regulations on Supervision and Administration of Medical Devices", carry out special rectification of medical devices in depth, and effectively strengthen the investigation and control of medical device risks and risks, the State Food and Drug Administration put forward the following requirements on comprehensively strengthening the consultation on the quality and safety risks of medical devices:

1. Deeply understand the importance of comprehensively strengthening the consultation on the quality and safety risks of medical devices. Drug regulatory departments at all levels should comprehensively strengthen consultation on medical device quality and safety risks, promptly discover and effectively deal with hidden risks of medical device quality and safety, further implement the main responsibilities of enterprises and the supervision responsibilities of regulatory departments, accelerate the construction of a risk management mechanism that combines risk identification, risk assessment and risk control, and effectively ensure the quality and safety of medical devices in my country.

2. Carefully organize consultations on quality and safety risks of medical devices. Regularly conduct risk consultations, comprehensively sort out risk information, scientifically carry out risk analysis and judgment, and ensure that risk treatment is in place.

3. Solidly promote the implementation of medical device quality and safety risk consultation and implementation. We will effectively strengthen organizational leadership, regard quality and safety risk consultation as an important part of strengthening medical device supervision, clarify goals and tasks, refine specific measures, and strengthen supervision and inspection to ensure that risk discovery is early and handled in the early stage, and prevent systematic and regional medical device quality and safety incidents in the jurisdiction. Steadily advance mechanism construction, and for the common problems found in risk consultation work, we must explore the root causes of them, strengthen institutional mechanism construction, and prevent and control quality and safety risks from the source. Summarize work experience in a timely manner, accelerate the improvement of the risk management mechanism that combines risk identification, risk assessment and risk control, and further improve the ability and level of medical device quality and safety risk prevention and control. (Comprehensive Department of the State Food and Drug Administration)

9. [Minery Medical Activist Recalls Tumor-related Antigen 125 Calibrator]

On May 12, the official website of the State Food and Drug Administration disclosed that the production batch number of the tumor-related antigen 125 Calibrator produced by Mindray Medical (300760.SZ) is 2021100100. During internal monitoring, it was found that the batch of CA125 Calibrators may have a stability risk, which may lead to "accuracy" exceeding the acceptable range of product technical requirements. Shenzhen Mindray decided to initiate an active recall, with the recall level three. (State Medical Administration)

Securities Research Report Observation

1. [The overall performance growth rate of the medical device sector slows down, and the internal partialization of the sector is obvious]

In the era of light medical beauty, medical dressings have emerged and developed rapidly. According to Frost & Sullivan data, the market size of dressing and patch products in China in 2017 was only 6.7 billion yuan, and then increased to 25.9 billion yuan in 2021 with a CAGR of 40.2%. In the future, with the increase in the scale of light medical beauty users and the demand for effective skin care, there is considerable development space.

Featured economy drives demand growth, and product channel evolution accelerates penetration.Demand side: Economical appearance, sensitive skin, and effective skin care jointly drive the growth of demand for medical dressings. Product side: my country's medical device products are subject to strict market access and product management. Under the high competitive barriers, the products are characterized by high pricing and high repurchase, and the profits of enterprises in the industry are maintained at a high level. Channel side: Online and offline drives to achieve coordinated growth, offline channels accumulate and accumulate and accumulate and differentiated management highlights advantages; online channels enjoy e-commerce dividends, and sales contribution gradually increases.

Since 2011, major companies have successively launched medical dressing products, which have been favored by medical institutions and consumers. Economies in appearance, sensitive skin and functional skin care have jointly driven the rapid development of the industry scale. At present, the overall competitive landscape of my country's medical dressing market is relatively scattered, with CR5 only accounting for about 26.5% of the market share. Leading companies are actively deploying online and offline channels and creating popular single products with diversified marketing methods. The industry penetration rate is expected to further increase in the future. (GF Securities)

2. [Special topic for innovative devices in the medical device industry: CGM technology is developing rapidly, and the domestic market is in full swing]

low penetration rate and high growth, and the CGM blue ocean market has set sail rapidly. Blood glucose monitoring is an important part of diabetes management, and it mainly relies on the detection of capillary blood glucose monitoring (SMBG), continuous glucose monitoring (CGM), glycated hemoglobin (HbA1c) and glycated albumin (GA).

my country's CGM is currently in the early stage of market cultivation (market size 1.7 billion yuan), with low penetration rate (type I 6.9%), and low domestic production rate (less than 5%), with great market potential. In 2019, the market size of my country's diabetes monitoring medical devices was about US$1 billion, and it is estimated that by 2030, my country's diabetes monitoring medical devices market will reach US$6.1 billion.

Among them, my country's CGM market was approximately 1.7 billion yuan in 2020, and the penetration rates of CGM of type I, type II and gestational diabetes were 6.9%, 1.1% and 0.3%, respectively. It is expected to reach 38%, 13% and 1% by 2030. It is estimated that the market size of CGM will rapidly grow to 17.9 billion yuan with a CAGR=27%. (Southwest Securities)

3. [The enlightenment after the 62 round of centralized procurement, what is the impact of centralized procurement of high-value consumables in different life cycles? 】

high-value consumables centralized procurement continues to accelerate, and mature varieties may be the first to usher in the provincial centralized procurement expansion. In 2020, the domestic medical device market size was approximately 811.8 billion yuan (+15.5%), of which high-value consumables accounted for about 22.8%. The total market value of high-value consumables A-shares has reached 257 billion yuan, accounting for about 17.3% of the market value of the medical device sector. It is a sub-sector worth focusing on exploring investment opportunities.

So far in 2019, high-value consumables have undergone about 62 rounds of centralized procurement, covering about 17 varieties such as coronary artery and orthopedics. It can be found that most centralized procurement has gradually expanded its scope from a single province after several rounds of alliance procurement. Each variety produced and alliance procurement has undergone at least one round of provincial and municipal procurement. We believe that the probability of large-scale procurement in the short term is relatively low.

Based on the regional procurement situation in the past three years and the previously proposed target of 5 provincial varieties per province by the Medical Insurance Bureau, it is expected that the procurement of balloon catheters, artificial lenses, etc. may be the first to expand.

coronary stent domestic production rate exceeds 70%, and it is under short-term pressure after centralized procurement, and more innovative products are expected to become the strategic main axis. The domestic production rate of artificial joint implantation is about 44%, the impact of centralized procurement is relatively mild, and the domestic production rate has steadily increased. The domestic production rate of artificial lenses is about 20%, and the regional centralized procurement effect is limited, so the domestic impact is more favorable. (Zhongtai Securities)

4. [Rehabilitation medical device industry: policy support, double supply and demand, broad prospects]

Rehabilitation medical device, in line with the direction of policy encouragement, the trend of population aging and consumption upgrading, has sufficient endogenous growth momentum, and the industry is expected to usher in rapid development.

Demand side: Residents' living standards have improved, and their rehabilitation needs have gradually become "awakened". The rehabilitation needs include both basic disease rehabilitation and postpartum rehabilitation, exercise rehabilitation, and child rehabilitation with obvious consumption upgrade attributes. It is estimated that the market size of rehabilitation medical devices will be 81 billion yuan in 2025, with a CAGR of 13.97% from 2021 to 2025.

Supply side: Rehabilitation Science’s new infrastructure is expected to lead to a new round of procurement cycle. The number of rehabilitation specialist hospitals and rehabilitation departments in my country has grown rapidly since 2011, and the third-level system of rehabilitation medical care in my country has also been established.With the introduction of national policies, the National Health Commission has promoted 15 provinces to take the lead in carrying out policy-driven policy-driven work such as rehabilitation medical service pilot work, and the rehabilitation end is expected to usher in a new rehabilitation infrastructure cycle.

payment side: expansion of medical insurance payment projects and pilot projects for long-term care insurance are expected to provide financial insurance for rehabilitation treatment. In September 2020, the Medical Insurance Bureau and the Ministry of Finance issued the "Guiding Opinions of the Medical Insurance Bureau and the Ministry of Finance on Expanding the Pilot of the Long-term Care Insurance System", which determined 48 prefecture-level cities in 28 provinces as pilot projects, and explored the establishment of a social insurance system that raises funds through mutual assistance and mutual assistance, provides services or financial protection for long-term disabled people, and provides services or financial protection for medical care closely related to them. (Hua'an Securities)

5. [Equipment chapter of the series of reports on the medical device industry chain: A broad view of the problem, accumulate strength and make progress]

The epidemic has exposed the shortcomings of the domestic medical device industry chain, and the industrial chain of the "14th Five-Year Plan" is optimized and upgraded. During the epidemic, the shortage of core components of domestic anti-epidemic products such as ventilators highlights the importance of localization of the supply chain. In the post-epidemic era, the global industrial chain has shown a development trend of localization, decentralization and regionalization.

In December 2021, the Ministry of Industry and Information Technology and ten other departments issued the "14th Five-Year Plan for the Development of Medical Equipment Industry", encouraging domestic brands to realize independent research and development of core components upstream of the industrial chain.

medical equipment has high upstream barriers, and the domestic production rate of core components such as high-power CT ball tubes still needs to be improved.

1) Medical imaging equipment: high-power CT bulb tubes and other technical barriers are relatively high and the degree of domestic production is low. United Imaging Medical has strong international competitiveness in 3.0T and 5.0T superconducting magnets, MR power amplifiers, PET and CT detectors.

2) Ventilator: Core components such as proportional valves, solenoid valves, turbine fans, sensors, etc. are mainly imported, and some domestic brands have achieved breakthroughs in some fields.

3) Ultrasonic: Domestic manufacturers can independently produce core component ultrasonic probes. FPGA chips are mainly imported, and general-purpose chips and electronic components can be supplied by domestic manufacturers.

4) Endoscope: Soft mirrors have many parts and a complex supply chain, and most parts rely on manual manufacturing and assembly, with high manufacturing process requirements; the rise of CMOS breaks the monopoly pattern of Japanese companies in the soft mirror market. In the field of hard mirrors, the domestic brand Haitai Xinguang has strong strength in the upstream of hard mirrors and can independently produce core components such as fluorescent endoscopes and light source modules. (CICC Securities)

Industry Observation: The new regulations have been implemented for the first time, and the number of innovative medical equipment has increased by 160% year-on-year

On March 18, 2021, the State Food and Drug Administration issued the "Medical Device Supervision and Administration Regulations (Revised Version)" (hereinafter referred to as the "Regulations"), which will come into effect on June 1, 2021.

The Regulations were formulated in 2000, were fully revised for the first time in 2014, and were partially revised in 2017. This revision follows the four strictest requirements of "the most rigorous standards, the strictest supervision, the most severe punishment, and the most serious accountability". It mainly revises it in terms of innovative development, medical device registrant system, supervision and punishment, and the number of regulations has been added from the original 80 to the current 107.

Medical device innovation is the source and driving force for the development of the industry. In the newly revised "Regulations", it is specifically emphasized that medical device innovation should be included in the development focus, and innovative medical devices should be given priority review and approval, support the clinical promotion and use of innovative medical devices, and promote high-quality development of the industry.

The Regulations also point out that it is supported to establish or jointly establish research and development institutions, and to cooperate with universities, research institutes, medical institutions, etc. to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation capabilities of medical devices.

Since then, the State Food and Drug Administration has successively issued a number of relevant documents to further provide guidance for the implementation of the Regulations and promote the rapid development of the medical device industry. For example, on August 26, 2021, the "Regulations on the Registration and Filing of Medical Devices" and the "Regulations on the Registration and Filing of In vitro Diagnostic Reagents" were issued, which made more specific and detailed requirements on the "Regulations" regarding the registration and filing of medical devices, adjusted the relevant requirements for the clinical evaluation of medical devices, and clearly pointed out the situation of exemption from submitting clinical evaluation materials.

September 28, 2021, in order to strengthen the supervision and guidance of medical device product registration work and further improve the quality of registration review, the State Food and Drug Administration issued 5 technical guidance principles, including "Technical Guidelines for Clinical Evaluation of Medical Devices", "Technical Guidelines for Deciding whether to Carry out Clinical Trials of Medical Devices", and "Technical Guidelines for Comparative Explanation of Products Exempted from Clinical Evaluation of Medical Devices".

In March this year, many documents such as "Medicine Device Production Supervision and Administration Measures", "Medicine Device Operation Supervision and Administration Measures", and "Catalogue of Prohibited Medical Device Production" were issued intensively, announcing that the pace of construction of my country's medical device supervision regulations and system system is accelerating, and the relevant system of regulations and systems are gradually being improved.

The Regulations and the above-mentioned documents have provided convenience for medical device companies, stimulated more enterprises to invest in innovation, and promoted the improvement of the domestic production rate of medical devices; at the same time, the above-mentioned documents have also put forward higher requirements for medical device companies, implemented supervision of the entire life cycle of medical device products, and provided guarantees for medical device users.

For example, the Regulations include medical device products in the priority review and approval procedures, which will further accelerate the market launch process of innovative medical device products and promote the development of this field. Judging from the number of innovative medical device products approved by the State Food and Drug Administration, from January to May 2020 to January to May 2022, the number of newly approved innovative medical devices in China was 10, 10 and 26 respectively. The number of innovative medical devices approved for marketing in the first five months of 2022 increased by 160% compared with the same period in the previous two years. It can be seen that in the year after the implementation of the new "Regulations", my country's newly approved innovative medical device products have significantly improved.

[Risk Warning]: Policy control risks, domestic substitution is less than expected, and the epidemic affects production and operation.

(full text 8722 words)

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