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    Home > Medical News > Medical Research Articles > Approved for half a year for registration of orthopedic products with the highest proportion of 100 spine products

    Approved for half a year for registration of orthopedic products with the highest proportion of 100 spine products

    • Last Update: 2021-07-30
    • Source: Internet
    • Author: User
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      Medical News, July 28.
    Recently, the State Food and Drug Administration issued an announcement on the approval and registration of 163 medical device products (June 2021), including 110 domestic third-class medical device products and 28 imported third-class medical device products.
    There are 23 imported second-class medical equipment products and 2 medical equipment products from Hong Kong, Macao and Taiwan

    .
     
      According to statistics, from January to June 2021, the State Food and Drug Administration approved and registered a total of 736 medical devices , including 100 orthopedic products, 35 spinal products, 19 trauma products, 18 joint products, and 24 sports products.
    Medical products and 4 other categories of products

    .
     
      Orthopedics high-quality track, domestic alternatives have broad prospects
     
      As we age, the prevalence of orthopedic diseases such as fractures, scoliosis, spondylopathies, and arthritis will become higher and higher, and the base of orthopedic patients will gradually increase
    .
    In addition, the number of sports people in China is increasing year by year.
    It is estimated that by 2025, the domestic sports population will reach 500 million.
    The subsequent increase in the incidence of sports injury diseases, and the demand for orthopedic treatment will continue to grow

    .
    It is estimated that the compound annual growth rate of the domestic orthopedics equipment market is about 15%, which shows that orthopedics will be a high-growth and high-increment market in the future

    .
     
      Under this high-quality track, domestic orthopedic companies have made efforts in product layout, technology research and development, brand marketing, etc.
    , gradually squeezing the import market and gradually realizing domestic substitution

    .
    At present, the highest rate of localization is the trauma market, followed by the spine market, and the lowest rate of localization is the joint market

    .
     
      trauma
     
      Trauma is the largest orthopedic market segment in China, and it is also the segment with the highest proportion of localization, with domestic production accounting for more than 80%
    .
    Due to the relatively low technical threshold of trauma products, there are more than 100 domestic trauma manufacturers, and the industry concentration is low

    .
     
      spine
     
      Benefiting from the high boom in the orthopedics industry, the spinal implant industry has maintained rapid growth in recent years
    .
    However, the domestic spine consumables market is still dominated by foreign brands such as Johnson & Johnson and Medtronic.
    In 2019, China’s orthopedic spine implant market, Johnson & Johnson, Medtronic, and Stryker combined accounted for 59.
    18% of the market share

    .
    Import substitution has great potential

    .
     
      joint
     
      The aging rate of our country is rising continuously
    .
    According to statistics, about 50% of people over 50 years old suffer from osteoarthritis, and people over 75 years old account for 80%

    .
    In this case, the joint track is bound to be a large incremental market in the future

    .
    Joints are one of the market segments with the highest manufacturing threshold, the most difficult process, and the highest technological content among orthopedic implant consumables.
    At present, China's joint implants mainly rely on imports

    .
     
      sports medicine
     
      Sports medicine is the fastest growing segment of the orthopedics market.
    It is estimated that the global sports medicine market will exceed US$9 billion in 2024, which is in a stage of rapid growth

    .
    Due to the high technical barriers of the industry and the blockade of patented technologies, China's sports medicine is still in a state of import monopoly.
    International giants such as Xerox, Ruishi, Johnson & Johnson and Stryker have long occupied more than 90% of the domestic market share

    .
     
      Intensive intensive procurement, orthopedic consumables were "broken"
     
      On July 31, 2019, the General Office of the State Council issued the "Notice on the Reform Plan for Governance of High-Value Medical Consumables" to explore mass procurement in the field of high-value medical consumables
    .
     
      Some orthopedic consumables are included in the volume procurement by the state, alliance and province due to the characteristics of large clinical consumption, high purchase amount, mature clinical use, sufficient market competition, and high level of homogeneity
    .
     
      According to incomplete statistics, as of July 2021, 15 batches of local procurement of orthopedics have been carried out, covering categories such as trauma, spine, joints, synthetic bones, sports medicine and other products, with an average reduction range of 32%-88 %, the highest drop range is 61%-95%
    .
     
      Centralized procurement of provincial and multi-provincial alliances is the "main force" in the centralized procurement of orthopedic consumables.
    The recently launched 12-provincial alliance has the largest volume of trauma collections, and the decline is also alarming.
    The average decline is 88.
    65%, and the highest decline is 95.
    78%

    .
    Among them, the price of ordinary bone plate systems has dropped from an average of 4683 yuan to about 606 yuan; the price of locking (universal) compression plate systems has dropped from an average of 9360 yuan to about 987 yuan; the price of intramedullary nail system has dropped from an average of 11,687 yuan.
    It fell to about 1271 yuan

    .
     
      After continuous local testing of the water, the national joint procurement has also continued to advance.
    On June 21, the
    official website of Tianjin
    Pharmaceutical Purchasing Center issued the "National Organization of Artificial Joint Centralized Procurement Announcement (No.
    1)".
    A comprehensive description of the types of procurement, corporate qualifications and procurement rules adopted

    .
     
      Judging from the current trend, the price reduction of the national procurement of orthopedic joints may not be lower than that of the national procurement of coronary stents last year
    .
     
      As the coverage of orthopedic centralized sourcing products continues to expand, more products will fall sharply, and more companies will usher in life and death.
    Successful bidders will exchange price for volume, unsuccessful companies will face the risk of being eliminated and the industry will face a reshuffle

    .
    At the same time, centralized procurement also brings more development opportunities to enterprises with strong innovation capabilities, and will enter the fast lane of development under the promotion of policies in the future

    .
     
      Attachment: Orthopedic medical device products approved from January to June 2021
      Medical News, July 28.
    Recently, the State Food and Drug Administration issued an announcement on the approval and registration of 163 medical device products (June 2021), including 110 domestic third-class medical device products and 28 imported third-class medical device products.
    There are 23 imported second-class medical equipment products and 2 medical equipment products from Hong Kong, Macao and Taiwan

    .
     
      According to statistics, from January to June 2021, the State Food and Drug Administration approved and registered a total of 736 medical devices , including 100 orthopedic products, 35 spinal products, 19 trauma products, 18 joint products, and 24 sports products.
    Medical products and 4 other categories of products

    .
     
      Orthopedics high-quality track, domestic alternatives have broad prospects
     
      As we age, the prevalence of orthopedic diseases such as fractures, scoliosis, spondylopathies, and arthritis will become higher and higher, and the base of orthopedic patients will gradually increase
    .
    In addition, the number of sports people in China is increasing year by year.
    It is estimated that by 2025, the domestic sports population will reach 500 million.
    The subsequent increase in the incidence of sports injury diseases, and the demand for orthopedic treatment will continue to grow

    .
    It is estimated that the compound annual growth rate of the domestic orthopedics equipment market is about 15%, which shows that orthopedics will be a high-growth and high-increment market in the future

    .
     
      Under this high-quality track, domestic orthopedic companies have made efforts in product layout, technology research and development, brand marketing, etc.
    , gradually squeezing the import market and gradually realizing domestic substitution

    .
    At present, the highest rate of localization is the trauma market, followed by the spine market, and the lowest rate of localization is the joint market

    .
     
      trauma
     
      Trauma is the largest orthopedic market segment in China, and it is also the segment with the highest proportion of localization, with domestic production accounting for more than 80%
    .
    Due to the relatively low technical threshold of trauma products, there are more than 100 domestic trauma manufacturers, and the industry concentration is low

    .
     
      spine
     
      Benefiting from the high boom in the orthopedics industry, the spinal implant industry has maintained rapid growth in recent years
    .
    However, the domestic spine consumables market is still dominated by foreign brands such as Johnson & Johnson and Medtronic.
    In 2019, China’s orthopedic spine implant market, Johnson & Johnson, Medtronic, and Stryker combined accounted for 59.
    18% of the market share

    .
    Import substitution has great potential

    .
     
      joint
     
      The aging rate of our country is rising continuously
    .
    According to statistics, about 50% of people over 50 years old suffer from osteoarthritis, and people over 75 years old account for 80%

    .
    In this case, the joint track is bound to be a large incremental market in the future

    .
    Joints are one of the market segments with the highest manufacturing threshold, the most difficult process, and the highest technological content among orthopedic implant consumables.
    At present, China's joint implants mainly rely on imports

    .
     
      sports medicine
     
      Sports medicine is the fastest growing segment of the orthopedics market.
    It is estimated that the global sports medicine market will exceed US$9 billion in 2024, which is in a stage of rapid growth

    .
    Due to the high technical barriers of the industry and the blockade of patented technologies, China's sports medicine is still in a state of import monopoly.
    International giants such as Xerox, Ruishi, Johnson & Johnson and Stryker have long occupied more than 90% of the domestic market share

    .
     
      Intensive intensive procurement, orthopedic consumables were "broken"
     
      On July 31, 2019, the General Office of the State Council issued the "Notice on the Reform Plan for Governance of High-Value Medical Consumables" to explore mass procurement in the field of high-value medical consumables
    .
     
      Some orthopedic consumables are included in the volume procurement by the state, alliance and province due to the characteristics of large clinical consumption, high purchase amount, mature clinical use, sufficient market competition, and high level of homogeneity
    .
     
      According to incomplete statistics, as of July 2021, 15 batches of local procurement of orthopedics have been carried out, covering categories such as trauma, spine, joints, synthetic bones, sports medicine and other products, with an average reduction range of 32%-88 %, the highest drop range is 61%-95%
    .
     
      Centralized procurement of provincial and multi-provincial alliances is the "main force" in the centralized procurement of orthopedic consumables.
    The recently launched 12-provincial alliance has the largest volume of trauma collections, and the decline is also alarming.
    The average decline is 88.
    65%, and the highest decline is 95.
    78%

    .
    Among them, the price of ordinary bone plate systems has dropped from an average of 4683 yuan to about 606 yuan; the price of locking (universal) compression plate systems has dropped from an average of 9360 yuan to about 987 yuan; the price of intramedullary nail system has dropped from an average of 11,687 yuan.
    It fell to about 1271 yuan

    .
     
      After continuous local testing of the water, the national joint procurement has also continued to advance.
    On June 21, the
    official website of Tianjin
    Pharmaceutical Purchasing Center issued the "National Organization of Artificial Joint Centralized Procurement Announcement (No.
    1)".
    A comprehensive description of the types of procurement, corporate qualifications and procurement rules adopted

    .
     
      Judging from the current trend, the price reduction of the national procurement of orthopedic joints may not be lower than that of the national procurement of coronary stents last year
    .
     
      As the coverage of orthopedic centralized sourcing products continues to expand, more products will fall sharply, and more companies will usher in life and death.
    Successful bidders will exchange price for volume, unsuccessful companies will face the risk of being eliminated and the industry will face a reshuffle

    .
    At the same time, centralized procurement also brings more development opportunities to enterprises with strong innovation capabilities, and will enter the fast lane of development under the promotion of policies in the future

    .
     
      Attachment: Orthopedic medical device products approved from January to June 2021
      Medical News, July 28.
    Recently, the State Food and Drug Administration issued an announcement on the approval and registration of 163 medical device products (June 2021), including 110 domestic third-class medical device products and 28 imported third-class medical device products.
    There are 23 imported second-class medical equipment products and 2 medical equipment products from Hong Kong, Macao and Taiwan

    .
     
      According to statistics, from January to June 2021, the State Food and Drug Administration approved and registered a total of 736 medical devices , including 100 orthopedic products, 35 spinal products, 19 trauma products, 18 joint products, and 24 sports products.
    Medical products and 4 other categories of products

    .
    Medical equipment medical equipment medical equipment
     
      Orthopedics high-quality track, domestic alternatives have broad prospects
      Orthopedics high-quality track, domestic alternatives have broad prospects
     
      As we age, the prevalence of orthopedic diseases such as fractures, scoliosis, spondylopathies, and arthritis will become higher and higher, and the base of orthopedic patients will gradually increase
    .
    In addition, the number of sports people in China is increasing year by year.
    It is estimated that by 2025, the domestic sports population will reach 500 million.
    The subsequent increase in the incidence of sports injury diseases, and the demand for orthopedic treatment will continue to grow

    .
    It is estimated that the compound annual growth rate of the domestic orthopedics equipment market is about 15%, which shows that orthopedics will be a high-growth and high-increment market in the future

    .
     
      Under this high-quality track, domestic orthopedic companies have made efforts in product layout, technology research and development, brand marketing, etc.
    , gradually squeezing the import market and gradually realizing domestic substitution

    .
    At present, the highest rate of localization is the trauma market, followed by the spine market, and the lowest rate of localization is the joint market

    .
    Enterprise business enterprise
     
      trauma
      trauma
     
      Trauma is the largest orthopedic market segment in China, and it is also the segment with the highest proportion of localization, with domestic production accounting for more than 80%
    .
    Due to the relatively low technical threshold of trauma products, there are more than 100 domestic trauma manufacturers, and the industry concentration is low

    .
     
      spine
      spine
     
      Benefiting from the high boom in the orthopedics industry, the spinal implant industry has maintained rapid growth in recent years
    .
    However, the domestic spine consumables market is still dominated by foreign brands such as Johnson & Johnson and Medtronic.
    In 2019, China’s orthopedic spine implant market, Johnson & Johnson, Medtronic, and Stryker combined accounted for 59.
    18% of the market share

    .
    Import substitution has great potential

    .
     
      joint
      joint
     
      The aging rate of our country is rising continuously
    .
    According to statistics, about 50% of people over 50 years old suffer from osteoarthritis, and people over 75 years old account for 80%

    .
    In this case, the joint track is bound to be a large incremental market in the future

    .
    Joints are one of the market segments with the highest manufacturing threshold, the most difficult process, and the highest technological content among orthopedic implant consumables.
    At present, China's joint implants mainly rely on imports

    .
     
      sports medicine
      sports medicine
     
      Sports medicine is the fastest growing segment of the orthopedics market.
    It is estimated that the global sports medicine market will exceed US$9 billion in 2024, which is in a stage of rapid growth

    .
    Due to the high technical barriers of the industry and the blockade of patented technologies, China's sports medicine is still in a state of import monopoly.
    International giants such as Xerox, Ruishi, Johnson & Johnson and Stryker have long occupied more than 90% of the domestic market share

    .
     
      Intensive intensive procurement, orthopedic consumables were "broken"
     
      On July 31, 2019, the General Office of the State Council issued the "Notice on the Reform Plan for Governance of High-Value Medical Consumables" to explore mass procurement in the field of high-value medical consumables
    .
    Procurement Procurement Procurement
     
      Some orthopedic consumables are included in the volume procurement by the state, alliance and province due to the characteristics of large clinical consumption, high purchase amount, mature clinical use, sufficient market competition, and high level of homogeneity
    .
     
      According to incomplete statistics, as of July 2021, 15 batches of local procurement of orthopedics have been carried out, covering categories such as trauma, spine, joints, synthetic bones, sports medicine and other products, with an average reduction range of 32%-88 %, the highest drop range is 61%-95%
    .
    Sports, sports, sports
     
      Centralized procurement of provincial and multi-provincial alliances is the "main force" in the centralized procurement of orthopedic consumables.
    The recently launched 12-provincial alliance has the largest volume of trauma collections, and the decline is also alarming.
    The average decline is 88.
    65%, and the highest decline is 95.
    78%

    .
    Among them, the price of ordinary bone plate systems has dropped from an average of 4683 yuan to about 606 yuan; the price of locking (universal) compression plate systems has dropped from an average of 9360 yuan to about 987 yuan; the price of intramedullary nail system has dropped from an average of 11,687 yuan.
    It fell to about 1271 yuan

    .
     
      After continuous local testing of the water, the national joint procurement has also continued to advance.
    On June 21, the
    official website of Tianjin
    Pharmaceutical Purchasing Center issued the "National Organization of Artificial Joint Centralized Procurement Announcement (No.
    1)".
    A comprehensive description of the types of procurement, corporate qualifications and procurement rules adopted

    .
    Medicine Medicine Medicine
     
      Judging from the current trend, the price reduction of the national procurement of orthopedic joints may not be lower than that of the national procurement of coronary stents last year
    .
     
      As the coverage of orthopedic centralized sourcing products continues to expand, more products will fall sharply, and more companies will usher in life and death.
    Successful bidders will exchange price for volume, unsuccessful companies will face the risk of being eliminated and the industry will face a reshuffle

    .
    At the same time, centralized procurement also brings more development opportunities to enterprises with strong innovation capabilities, and will enter the fast lane of development under the promotion of policies in the future

    .
     
      Attachment: Orthopedic medical device products approved from January to June 2021
      Attachment: Orthopedic medical device products approved from January to June 2021
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