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    Home > Active Ingredient News > Drugs Articles > Review of the development of the medical device field in 2021

    Review of the development of the medical device field in 2021

    • Last Update: 2022-01-25
    • Source: Internet
    • Author: User
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    01 Overall Analysis

    01 Overall Analysis

    1.
    Continuous improvement of medical device regulatory policies

    1.
    Continuous improvement of medical device regulatory policies

    In 2021, China will introduce a number of medical device-related management measures, industry standards, etc.
    , and continue to improve the industry supervision in the field of medical devices
    .

    On February 4, the National Health and Medical Commission issued the "Administrative Measures for the Clinical Use of Medical Devices" and officially implemented it on March 1, requiring "if any medical device is found to have potential safety hazards, the medical institution should immediately stop using it and notify the medical device.
    The registrant, filing person or other organization responsible for product quality shall conduct maintenance; medical devices that cannot meet the safety standards for use after maintenance shall not continue to be used
    .



    On June 1, the newly revised "Regulations on the Supervision and Administration of Medical Devices" was officially implemented, and the registrant will bear the corresponding legal responsibility for the quality of medical devices throughout the life cycle.
    , All enterprises and medical device research and development institutions that hold a medical device registration certificate or have handled the filing of Class I medical devices shall, in accordance with the new "Regulations", perform the obligations of medical device registrants and filers respectively, and strengthen the life cycle of medical devices.
    Periodic quality management, taking responsibility for the safety and effectiveness of medical devices in the whole process of development, production, operation, and use according to law
    .

    In July, the General Department of the State Food and Drug Administration issued the "Notice on Printing and Distributing the 2021 Medical Device Industry Standard Formulation and Revision Plan Project" and "Announcement on Doing a Good Job in the Second Batch of Implementing the Unique Identification of Medical Devices (Draft for Comment)".
    On the basis of the first batch of 69 varieties of 9 categories, the rest of the third category of medical devices (including in vitro diagnostic reagents) will be included in the scope of the second batch of implementation of unique identification, and support and encouragement of other medical device varieties to implement unique identification
    .

    2.
    The procurement of high-value medical consumables is becoming normalized

    2.
    The procurement of high-value medical consumables is becoming normalized

    The main theme of the medical device industry in 2021 is undoubtedly the centralized procurement of high-value medical consumables that is gradually becoming normalized
    .

    After the national centralized procurement of the first batch of high-value consumables for coronary stents just settled, the second batch of high-value medical consumables for orthopaedics began immediately
    .


    At present, the localization rate in the domestic joint field only accounts for about 20-30%.


    On April 1, the state organized the joint procurement office of high-value medical consumables (hereinafter referred to as "joint procurement") to issue the "Notice on Carrying out the Information Collection of Orthopedic High-value Medical Consumables" and officially opened the second round of high-value consumables.
    Centralized procurement - the prelude to the centralized procurement of orthopedic consumables, the first batch of product information collection for high-value medical consumables such as artificial hip joints and artificial knee joints
    .

    On June 21, the National Joint Procurement Office issued the "Announcement on the Centralized Procurement of Artificial Joints by the State Organization (No.
    1)", which determined that the centralized procurement products were the primary replacement of the artificial total hip joint and the primary replacement of the artificial total knee joint
    .

    On August 23, the Joint Procurement Office released the "National Organization of Artificial Joints Centralized Procurement Document (GH-HD2021-1)", which clarified the intended procurement volume of each product system category, of which the total intended procurement volume of the hip joint product system in the first year is 305,542 (126,797 ceramic-ceramic hip joint product systems, 142,757 ceramic-polyethylene hip joint product systems, and 35,988 alloy-polyethylene hip joint product systems), and the total intended purchase of knee joint product systems in the first year is 231,976
    .

    On September 14, the national centralized procurement of high-value artificial joint consumables opened in Tianjin
    .


    In this round of centralized procurement, a total of 48 companies bid for more than 140 products.


    Figure 1: Memorabilia of centralized procurement of high-value medical consumables in 2021 Source: Flint Creation Database

    At the same time, the centralized procurement of other high-value medical consumables is also continuing to advance
    .


    As of the end of August, both coronary balloons and intraocular lenses have been collected in 31 provinces, achieving full coverage


    It is worth mentioning that, after 10 months of experience accumulation, this time, the national procurement paid more attention to the market and clinical needs, and made several improvements in the bidding rules.
    Instead of comparing the quoted price, the price comparison was used to compare prices.
    On the basis of ensuring corporate profits, the goal of reducing prices is maximized
    .


    At the same time, the National Medical Insurance Bureau also issued the "Letter on the Reply to the Proposal No.


    02 Analysis of medical device products in 2021

    02 Analysis of medical device products in 2021

    1.
    Approved Class II and III medical devices

    1.
    Approved Class II and III medical devices

    In 2021, NMPA and provincial drug administrations approved a total of 32,450 Class II and Class III medical devices, including 13,326 first-time registered products and 19,124 re-registered products, accounting for 41.
    1% of first-time registered products, down from 57.
    1% in 2020
    .


    Among the products registered for the first time, there are 991 Class III devices, accounting for 7.


    Figure 2: my country's approval of Class II and III medical devices in 2021 Source: NMPA, Firestone Creation

    In terms of geographical distribution, the top five provinces (autonomous regions and municipalities) in the number of approved Class III devices are Beijing, Jiangsu, Guangdong, Shanghai and Shandong, and the top five provinces (autonomous regions and municipalities) in the number of approved Class II devices are Guangdong, Jiangsu, Zhejiang, Hunan and Henan, and the five provinces (autonomous regions and municipalities) with the highest proportion of three types of devices are Shanghai, Fujian, Beijing, Tianjin and Gansu
    .

    Table 1: The number of approved medical devices in each province (autonomous region, city) in 2021

    Source: Flint Creation Database

    2.
    Special review of innovative medical devices

    2.
    Special review of innovative medical devices

    As of December 31, 2021, CMDE has announced 357 products included in the special review process for innovative medical devices, and a total of 120 products have been approved for marketing through this process
    .


    Among them, a total of 60 innovative medical devices will be included in special approval in 2021, and 28 will be successfully approved for marketing


    Figure 3: The implementation of the special approval procedures for innovative medical devices in my country Source: CMDE, Firestone Creation (approved products are calculated based on the registration certificate)

    Table 2: Products approved for marketing under the special approval process for innovative medical devices in 2021

    Source: CMDE, Flint Creation

    8 softwares were selected as new highs
    .


    In 2021, a total of 8 medical software products will be included in the special review process for innovative medical devices, setting a record high, of which 2 models from Healthcare and Shanghai are selected


    8 softwares were selected as new highs


    Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang accounted for over 80%
    .

    3.
    Priority approval for medical devices

    3.
    Priority approval for medical devices

    As of December 31, 2021, CMDE has announced 59 products that have been included in the priority approval process for medical devices, and a total of 33 products have been approved for marketing through this process
    .
    Among them, a total of 14 medical devices will be included in priority approval in 2021, and 9 will be successfully approved for marketing
    .

    Figure 4: Implementation of the priority approval process for medical devices in my country Source: CMDE, Firestone Creation (approved products are calculated based on the registration certificate)

    Table 5: Products approved for listing under the priority approval process for medical devices in 2020

    Source: CMDE, Flint Creation

    Domestic varieties accounted for more than 60% of the priority products for approval
    .
    Among the products that will be prioritized for approval and publicity in 2021, there are 10 domestic varieties, accounting for 71.
    4% of all publicized varieties; 4 imported varieties, accounting for 28.
    6%
    .

    Domestic varieties accounted for more than 60% of the priority products for approval
    .

    "Inclusion in the national key research and development plan" is still the main reason for selection
    .
    Judging from the reasons for the selection of publicized products in 2020, the products "included in the national key research and development plan" accounted for 43% of all publicized varieties, which is still the most important reason for selection, followed by 29% of "clinical urgent" products
    .

    "Inclusion in the national key research and development plan" is still the main reason for selection
    .

    Figure 6: Distribution of reasons for selection in the priority approval process Source: CMDE, Firestone Creation

    03 Analysis of medical device companies in 2021

    03 Analysis of medical device companies in 2021

    1.
    IPO

    1.
    IPO

    In 2021, a total of 36 medical device companies across the country will complete IPO listings, including 13 listed on the Hong Kong Stock Exchange, 19 on the Science and Technology Innovation Board, and 4 on the ChiNext, including MicroPort Cardiovascular and Guichuang in the fields of high-value medical consumables such as cardiovascular and orthopaedics.
    Tongqiao, Weigao Orthopedics, Chunli Medical, Xianruida, Baixinan, Huitai Medical, etc.
    In the field of in vitro diagnostics, Haooubo, Botuo Bio, Nuohezhiyuan, Beikang Medical, etc.
    , as well as medical imaging equipment and Kangzhong Medical, Eagle Eye Technology, etc.
    in the field of AI medical imaging
    .

    2.
    M&A

    2.
    M&A

    The repeated outbreak of the epidemic and the strong promotion of the volume-based procurement policy have further accelerated the merger and reorganization process of medical device companies
    .
    The polarization of performance caused by the new crown epidemic has accelerated the merger and acquisition activities of enterprises, and a large number of enterprises damaged by the epidemic have become the acquisition targets of enterprises that have benefited from the epidemic
    .
    At the same time, the strong promotion of volume-based procurement has continuously reduced the cost of intermediate links of medical products and induced enterprises to carry out independent innovation.
    A single product line is often unable to support the scale and development of enterprises, and a large number of technologically innovative start-ups have become M&A targets of mature enterprises
    .

    In the global field, the targets of mergers and acquisitions are still concentrated in the fields of in vitro diagnosis, imaging and implantation intervention.
    Among the TOP10 global medical device mergers and acquisitions in 2021, 4 belong to the field of in vitro diagnosis
    .
    In addition, the trend of expanding product lines horizontally to other big health fields is becoming more and more obvious, such as Thermo Fisher's acquisition of clinical research service provider PPD, and PerkinElmer's acquisition of BioLegend, a leading brand of antibodies and reagents
    .

    Table 3: TOP10 M&A events in the global medical device field in 2021

    Source: Flint Creation Arranged based on public information

    The domestic medical device industry mergers and acquisitions are also heating up under the background of localization substitution
    .

    In terms of horizontal expansion, Lepu Medical entered the field of orthodontics through the acquisition of Bosimei; Sanyou Medical expanded its business boundaries to the field of ultrasonic surgery through the acquisition of Shuimu Tianpeng
    .

    In terms of vertical expansion, Mindray Medical made up for the shortcomings in in vitro diagnostic raw materials through the acquisition of Finland's HyTest Invest Oy (Hai Peptide Bio) and its subsidiaries
    .

    In terms of strengthening the competitiveness of product lines, the acquisition of Kehua Bio by Shengxiang Bio has enabled the two parties to join forces in terms of technology platform, product line, channel, and market; Yuyue Medical acquired Kailite to enhance diabetes and POCT businesses; The innovation of the medical enhancement product pipeline
    .

    Table 4: TOP12 M&A events in China's medical device field in 2021

    Source: Flint Creation Arranged based on public information

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