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    Home > Medical News > Latest Medical News > National Health and Wellness Commission: disposable medical supplies or was transferred out of the catalog!

    National Health and Wellness Commission: disposable medical supplies or was transferred out of the catalog!

    • Last Update: 2021-03-24
    • Source: Internet
    • Author: User
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    First, it is recommended that the drug regulatory authorities require or encourage companies to develop and produce reusable medical consumables during the approval of the medical device marketing .
    For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting unreasonable technical barriers;
     
    The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
     
    Not to be reused
     
    On February 4, the National Health Commission issued the "Administrative Measures for the Clinical Use of Medical Devices", which also put forward requirements for the reuse of consumables: medical devices that can be reused according to the regulations should be cleaned, disinfected or sterilized in strict accordance with the regulations, and the effect Monitoring; single-use medical devices must not be reused, and used ones should be destroyed and recorded in accordance with relevant national regulations.
     
    Prior to this, in August 2019, the National Medical Insurance Administration also mentioned this issue in the "National Medical Insurance Administration's Reply to Recommendation No.
    6395 of the Second Session of the Thirteenth National People's Congress".
     
      The National Medical Insurance Bureau stated that the recycling and reuse of disposable medical consumables involves relevant laws pharmnet.
    com.
    cn/" target="_blank">and regulations , technical guarantees such as the safety and effectiveness of reused products, the economic feasibility of reuse, social ethics, and doctor-patient relationships, which require joint research by multiple departments.
    Advance.
     
      In the next step, the State Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide support in technical aspects such as functional verification of reused products and safety and effectiveness assurance.
     
      It is understood that common single-use medical devices include: single-use sterile syringes, single-use infusion sets, and single-use blood transfusion sets
     
      According to data from the China Medical Materials Association, China's disposable medical device market reached 210.
    2 billion yuan in 2019, and the market size is expected to reach 546.
    8 billion yuan in 2025, with a compound annual growth rate of 17.
    3% during the period.
     
      According to China Industry Information Network, there are currently hundreds of disposable medical device products or medical supplies on the market.
    Among them, medical latex gloves, disposable syringes, surgical instruments and surgical plastic trays account for a relatively large number.
     
      In addition, orthopedic implants is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, Artificial joints, etc.
     
      In terms of market structure, the United States is the world's largest disposable medical device market, Europe is the second largest market, and China may become the world's largest disposable surgical gown market in the future.
      Medical News, February 23, disposable consumables, may cause a waste of resources
     
      Or not included in the catalog
     
      Recently, the National Health Commission issued the "Answer to Recommendation No.
    9780 of the Third Session of the 13th National People's Congress" (hereinafter referred to as "Answer"), which showed that some representatives proposed to adjust some ophthalmic non-implantable high-value surgical instruments to single-use Recommendations for the device catalog.
     
      In this regard, the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
    In practice, some medical consumables can be reused.
     
      Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
    According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
     
      The National Health Commission also stated that the next step will be to carry out work in several areas.
     
      First, it is recommended that the drug regulatory authorities require or encourage companies to develop and produce reusable medical consumables during the approval of the medical device marketing .
    For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting unreasonable technical barriers;
     
      The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
     
      Not to be reused
     
      On February 4, the National Health Commission issued the "Administrative Measures for the Clinical Use of Medical Devices", which also put forward requirements for the reuse of consumables: medical devices that can be reused according to the regulations should be cleaned, disinfected or sterilized in strict accordance with the regulations, and the effect Monitoring; single-use medical devices must not be reused, and used ones should be destroyed and recorded in accordance with relevant national regulations.
     
      Prior to this, in August 2019, the National Medical Insurance Administration also mentioned this issue in the "National Medical Insurance Administration's Reply to Recommendation No.
    6395 of the Second Session of the Thirteenth National People's Congress".
     
      The National Medical Insurance Bureau stated that the recycling and reuse of disposable medical consumables involves relevant laws pharmnet.
    com.
    cn/" target="_blank">and regulations , technical guarantees such as the safety and effectiveness of reused products, the economic feasibility of reuse, social ethics, and doctor-patient relationships, which require joint research by multiple departments.
    Advance.
     
      In the next step, the State Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide support in technical aspects such as functional verification of reused products and safety and effectiveness assurance.
     
      It is understood that common single-use medical devices include: single-use sterile syringes, single-use infusion sets, and single-use blood transfusion sets
     
      According to data from the China Medical Materials Association, China's disposable medical device market reached 210.
    2 billion yuan in 2019, and the market size is expected to reach 546.
    8 billion yuan in 2025, with a compound annual growth rate of 17.
    3% during the period.
     
      According to China Industry Information Network, there are currently hundreds of disposable medical device products or medical supplies on the market.
    Among them, medical latex gloves, disposable syringes, surgical instruments and surgical plastic trays account for a relatively large number.
     
      In addition, orthopedic implants is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, Artificial joints, etc.
     
      In terms of market structure, the United States is the world's largest disposable medical device market, Europe is the second largest market, and China may become the world's largest disposable surgical gown market in the future.
      Medical News, February 23, disposable consumables, may cause a waste of resources
     
      Or not included in the catalog
      Or not included in the catalog
     
      Recently, the National Health Commission issued the "Answer to Recommendation No.
    9780 of the Third Session of the 13th National People's Congress" (hereinafter referred to as "Answer"), which showed that some representatives proposed to adjust some ophthalmic non-implantable high-value surgical instruments to single-use Recommendations for the device catalog.
     
      In this regard, the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
    In practice, some medical consumables can be reused.
     
      Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
    According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
    Medicine, medicine, medicine
     
      The National Health Commission also stated that the next step will be to carry out work in several areas.
     
      First, it is recommended that the drug regulatory authorities require or encourage companies to develop and produce reusable medical consumables during the approval of the medical device marketing .
    For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting unreasonable technical barriers;
    Enterprise business enterprise
     
      The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
     
      Not to be reused
      Not to be reused
     
      On February 4, the National Health Commission issued the "Administrative Measures for the Clinical Use of Medical Devices", which also put forward requirements for the reuse of consumables: medical devices that can be reused according to the regulations should be cleaned, disinfected or sterilized in strict accordance with the regulations, and the effect Monitoring; single-use medical devices must not be reused, and used ones should be destroyed and recorded in accordance with relevant national regulations.
     
      Prior to this, in August 2019, the National Medical Insurance Administration also mentioned this issue in the "National Medical Insurance Administration's Reply to Recommendation No.
    6395 of the Second Session of the Thirteenth National People's Congress".
     
      The National Medical Insurance Bureau stated that the recycling and reuse of disposable medical consumables involves relevant laws pharmnet.
    com.
    cn/" target="_blank">and regulations , technical guarantees such as the safety and effectiveness of reused products, the economic feasibility of reuse, social ethics, and doctor-patient relationships, which require joint research by multiple departments.
    Advance.
    pharmnet.
    com.
    cn/" target="_blank">Regulationspharmnet.
    com.
    cn/" target="_blank"> and regulations
     
      In the next step, the State Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide support in technical aspects such as functional verification of reused products and safety and effectiveness assurance.
     
      It is understood that common single-use medical devices include: single-use sterile syringes, single-use infusion sets, and single-use blood transfusion sets
     
      According to data from the China Medical Materials Association, China's disposable medical device market reached 210.
    2 billion yuan in 2019, and the market size is expected to reach 546.
    8 billion yuan in 2025, with a compound annual growth rate of 17.
    3% during the period.
    Medicine Medicine Medicine Medical Device Medical Device Medical Device
     
      According to China Industry Information Network, there are currently hundreds of disposable medical device products or medical supplies on the market.
    Among them, medical latex gloves, disposable syringes, surgical instruments and surgical plastic trays account for a relatively large number.
     
      In addition, orthopedic implants is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, Artificial joints, etc.
     
      In terms of market structure, the United States is the world's largest disposable medical device market, Europe is the second largest market, and China may become the world's largest disposable surgical gown market in the future.
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