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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 divided 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
.
.
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 divided 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
.
