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    Home > Medical News > Latest Medical News > The newly revised "Class I Medical Device Product Catalog" was announced

    The newly revised "Class I Medical Device Product Catalog" was announced

    • Last Update: 2022-02-22
    • Source: Internet
    • Author: User
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    A few days ago, the State Food and Drug Administration released the newly revised "Class I Medical Device Product Catalog" (hereinafter referred to as the "Class I Catalog") to further guide the filing of Class I medical devices
    .
    The catalogue will take effect on January 1, 2022
    .
     
    It is reported that the newly revised "Class 1 Catalog" fully integrates the 2014 version of the Class 1 Catalog, the 2017 version of the "Medical Device Classification Catalog" (hereinafter referred to as the 2017 Catalog) and the first-class medical device products in the related medical device classification and definition documents previously released.
    Information, taking the 2017 version of the catalog as the main frame, including 19 sub-categories, 119 first-level product categories, 368 second-level product categories, and 2,629 product names in the 2017 version of the catalog, 90 more product information than the 2017 version of the catalog, new 538 product name examples
    .
     
    In order to better guide and standardize the filing of related products, the newly revised "Class 1 Catalog" adds the description of each sub-category, and clarifies the revised content of the sub-categories and the matters needing attention for product filing
    .
    At the same time, the "List of Prohibited Ingredients in Some Class I Medical Device Products" has also been compiled, which includes Chinese medicines, physical cooling equipment, phototherapy equipment accessories, Band-Aids, acupoint pressure stimulation devices and other products that are managed as Class I medical devices.
    Examples of specific ingredients such as chemicals and biological products are given
    .
    The newly revised "Class 1 Catalog" does not include in vitro diagnostic reagents and combination package products
    .
     
    In response to the problems of cold compresses, cold compress gel products with high class and low preparation, and non- medical devices being filed in accordance with the first class medical device, the newly revised "Class I Catalog" has revised the "09-02-03 Physical Cooling Equipment" in the 2017 version of the catalog.
    Product descriptions, intended use and examples of product names have been standardized and modified
    .
    In terms of ingredients, it is limited that the composition of such products should not include the ingredients listed in the "List of Prohibited Ingredients for Some Class I Medical Device Products"; in terms of intended use, it is limited to "local cooling for fever patients
    .
    Only used for body surface.
    " Intact skin"; the medical cold compress, medical cold compress headband, medical cold compress eye mask, and cold compress gel have been deleted from the product name examples
    .
     
    In the 2017 edition of the catalog, liquid and paste dressings are classified into categories I, II, and III according to their intended use and delivery methods
    .
    The newly revised "Class I Catalog" deletes the relevant contents of Class I liquid and paste dressings in the 2017 edition of the Catalog
    .
    That is to say, "non-sterile provided, by forming a protective layer on the wound surface, acting as a physical barrier, for the care of small wounds, abrasions, cuts and other superficial wounds and the surrounding skin" liquid and paste dressings Not included in the newly revised "Class 1 Catalog"
    .
     
      In addition, the State Food and Drug Administration has clarified the implementation matters related to the newly revised "Class I Catalog".
    For products that have been filed before January 1, 2022, the products in accordance with the newly revised "Class I Catalog" are still classified as Class I medical devices.
    However, if the content published in the filing information form and the relevant content of the product technical requirements for filing are inconsistent with the newly revised "Class 1 Catalog", the filing person shall complete the change of filing information before April 1, 2022, or propose to the original filing department to cancel the original filing.
    Filing and re-applying for the filing of Class I medical devices
    .
      A few days ago, the State Food and Drug Administration released the newly revised "Class I Medical Device Product Catalog" (hereinafter referred to as the "Class I Catalog") to further guide the filing of Class I medical devices
    .
    The catalogue will take effect on January 1, 2022
    .
     
      It is reported that the newly revised "Class 1 Catalog" fully integrates the 2014 version of the Class 1 Catalog, the 2017 version of the "Medical Device Classification Catalog" (hereinafter referred to as the 2017 Catalog) and the first-class medical device products in the related medical device classification and definition documents previously released.
    Information, taking the 2017 version of the catalog as the main frame, including 19 sub-categories, 119 first-level product categories, 368 second-level product categories, and 2,629 product names in the 2017 version of the catalog, 90 more product information than the 2017 version of the catalog, new 538 product name examples
    .
     
      In order to better guide and standardize the filing of related products, the newly revised "Class 1 Catalog" adds the description of each sub-category, and clarifies the revised content of the sub-categories and the matters needing attention for product filing
    .
    At the same time, the "List of Prohibited Ingredients in Some Class I Medical Device Products" has also been compiled, which includes Chinese medicines, physical cooling equipment, phototherapy equipment accessories, Band-Aids, acupoint pressure stimulation devices and other products that are managed as Class I medical devices.
    Examples of specific ingredients such as chemicals and biological products are given
    .
    The newly revised "Class 1 Catalog" does not include in vitro diagnostic reagents and combination package products
    .
     
      In response to the problems of cold compresses, cold compress gel products with high class and low preparation, and non- medical devices being filed in accordance with the first class medical device, the newly revised "Class I Catalog" has revised the "09-02-03 Physical Cooling Equipment" in the 2017 version of the catalog.
    Product descriptions, intended use and examples of product names have been standardized and modified
    .
    In terms of ingredients, it is limited that the composition of such products should not include the ingredients listed in the "List of Prohibited Ingredients for Some Class I Medical Device Products"; in terms of intended use, it is limited to "local cooling for fever patients
    .
    Only used for body surface.
    " Intact skin"; the medical cold compress, medical cold compress headband, medical cold compress eye mask, and cold compress gel have been deleted from the product name examples
    .
     
      In the 2017 edition of the catalog, liquid and paste dressings are classified into categories I, II, and III according to their intended use and delivery methods
    .
    The newly revised "Class I Catalog" deletes the relevant contents of Class I liquid and paste dressings in the 2017 edition of the Catalog
    .
    That is to say, "non-sterile provided, by forming a protective layer on the wound surface, acting as a physical barrier, for the care of small wounds, abrasions, cuts and other superficial wounds and the surrounding skin" liquid and paste dressings Not included in the newly revised "Class 1 Catalog"
    .
     
      In addition, the State Food and Drug Administration has clarified the implementation matters related to the newly revised "Class I Catalog".
    For products that have been filed before January 1, 2022, the products in accordance with the newly revised "Class I Catalog" are still classified as Class I medical devices.
    However, if the content published in the filing information form and the relevant content of the product technical requirements for filing are inconsistent with the newly revised "Class 1 Catalog", the filing person shall complete the change of filing information before April 1, 2022, or propose to the original filing department to cancel the original filing.
    Filing and re-applying for the filing of Class I medical devices
    .
      A few days ago, the State Food and Drug Administration released the newly revised "Class I Medical Device Product Catalog" (hereinafter referred to as the "Class I Catalog") to further guide the filing of Class I medical devices
    .
    The catalogue will take effect on January 1, 2022
    .
     
      It is reported that the newly revised "Class 1 Catalog" fully integrates the 2014 version of the Class 1 Catalog, the 2017 version of the "Medical Device Classification Catalog" (hereinafter referred to as the 2017 Catalog) and the first-class medical device products in the related medical device classification and definition documents previously released.
    Information, taking the 2017 version of the catalog as the main frame, including 19 sub-categories, 119 first-level product categories, 368 second-level product categories, and 2,629 product names in the 2017 version of the catalog, 90 more product information than the 2017 version of the catalog, new 538 product name examples
    .
     
      In order to better guide and standardize the filing of related products, the newly revised "Class 1 Catalog" adds the description of each sub-category, and clarifies the revised content of the sub-categories and the matters needing attention for product filing
    .
    At the same time, the "List of Prohibited Ingredients in Some Class I Medical Device Products" has also been compiled, which includes Chinese medicines, physical cooling equipment, phototherapy equipment accessories, Band-Aids, acupoint pressure stimulation devices and other products that are managed as Class I medical devices.
    Examples of specific ingredients such as chemicals and biological products are given
    .
    The newly revised "Class 1 Catalog" does not include in vitro diagnostic reagents and combination package products
    .
    acupoints , acupoints , medicines , medicines, medicines
     
      In response to the problems of cold compresses, cold compress gel products with high class and low preparation, and non- medical devices being filed in accordance with the first class medical device, the newly revised "Class I Catalog" has revised the "09-02-03 Physical Cooling Equipment" in the 2017 version of the catalog.
    Product descriptions, intended use and examples of product names have been standardized and modified
    .
    In terms of ingredients, it is limited that the composition of such products should not include the ingredients listed in the "List of Prohibited Ingredients for Some Class I Medical Device Products"; in terms of intended use, it is limited to "local cooling for fever patients
    .
    Only used for body surface.
    " Intact skin"; the medical cold compress, medical cold compress headband, medical cold compress eye mask, and cold compress gel have been deleted from the product name examples
    .
    medical device medical device medical device
     
      In the 2017 edition of the catalog, liquid and paste dressings are classified into categories I, II, and III according to their intended use and delivery methods
    .
    The newly revised "Class I Catalog" deletes the relevant contents of Class I liquid and paste dressings in the 2017 edition of the Catalog
    .
    That is to say, "non-sterile provided, by forming a protective layer on the wound surface, acting as a physical barrier, for the care of small wounds, abrasions, cuts and other superficial wounds and the surrounding skin" liquid and paste dressings Not included in the newly revised "Class 1 Catalog"
    .
     
      In addition, the State Food and Drug Administration has clarified the implementation matters related to the newly revised "Class I Catalog".
    For products that have been filed before January 1, 2022, the products in accordance with the newly revised "Class I Catalog" are still classified as Class I medical devices.
    However, if the content published in the filing information form and the relevant content of the product technical requirements for filing are inconsistent with the newly revised "Class 1 Catalog", the filing person shall complete the change of filing information before April 1, 2022, or propose to the original filing department to cancel the original filing.
    Filing and re-applying for the filing of Class I medical devices
    .
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