State Food and Drug Administration: Opinions on matters related to the filing of Class I medical devices

On March 2, the General Department of the State Food and Drug Administration issued a public solicitation for comments on the "Announcement on Matters Concerning the Filing of Class I Medical Devices (Draft for Comment)"
.

 

The opinion pointed out that in order to further do a good job in the filing of Class I medical devices, the State Food and Drug Administration organized the "Announcement on Matters Concerning the Filing of Class I Medical Devices " (No.
26, 2014) issued by the former State Food and Drug Administration.
It has been revised to form the "Announcement on Matters Concerning the Filing of Class I Medical Devices (Draft for Comment)", which is now open for comments .

 

The announcement highlights the following points:

 

1.
Medical device filing refers to the activity that the medical device filing person (hereinafter referred to as the filing person) submits filing materials to the drug regulatory department in accordance with legal procedures and requirements, and the drug regulatory department archives the submitted filing materials for future reference
.

 

2.
For the domestic first-class medical device filing, the filing person submits filing materials to the department responsible for drug supervision and administration at the city level with districts
.
For the filing of imported Class I medical devices, the filing person submits filing materials to the State Drug Administration
.

 

3.
According to the "Class I Medical Device Product Catalog", "In Vitro Diagnostic Reagent Classification Sub-Catalog" (hereinafter collectively referred to as the catalog) and relevant classification and definition notices, if it is determined to be a Class I medical device, the filing person shall go to the corresponding filing department for filing; If it is not included in the catalogue or the relevant classification and definition notice, it shall apply for classification and definition according to the relevant work procedures, and if it is clearly classified as a first-class medical device, it shall go through the recordation with the corresponding recordation department
.
When judging the product management category, it should be based on the actual situation of the product, according to the product description, intended use and product name examples in the "Class I Medical Device Product Catalog", "In Vitro Diagnostic Reagent Classification Sub-Catalog" and other regulations
.

 

　　4.
The filing person shall prepare the product technical requirements for filing medical devices as required
.

 

　　5.
For medical device filing, the filing person shall submit the filing materials in accordance with the requirements of Annex 1 and obtain the filing number
.
The filer shall ensure that the submitted materials are legal, true, accurate, complete and traceable
.

 

　　6.
The filing will be completed after the filing person submits the filing materials that meet the requirements of Annex 1
.
For the filed medical devices, the filing department shall, within 5 working days from the date of filing, publish the information in the "Class I Medical Device Filing Information Form" or the "Class I In Vitro Diagnostic Reagent Filing Information Form" (see Annex 3) relevant information
.

 

　　7.
For a medical device that has been filed, the content of the filing information table and the technical requirements of the filed product change, the filing person shall change the filing to the original filing department, and submit an explanation of the change and relevant documents
.
For medical devices that have been changed and filed, the filing department shall post the changes in the "Changes" column of the filing information form, and announce the relevant information of the changes within 5 working days from the date of the change filing
.

 

　　For products whose product descriptions in the "Class 1 Medical Device Product Catalog" include "should not contain ingredients that exert pharmacological, immunological or metabolic effects", if the ingredients are changed, the filer shall cancel the original filing and apply for another filing
.

 

　　8.
The recordation department shall carry out the recordation work in accordance with the operation specification for the recordation of Class I medical devices (see Annex 5)
.

 

　　In addition, the feedback form needs to be returned to the email address: ylqxzc@sina.
cn before March 31, 2022
.
Please indicate "Feedback on filing announcement" in the subject of the email
.

　　On March 2, the General Department of the State Food and Drug Administration issued a public solicitation for comments on the "Announcement on Matters Concerning the Filing of Class I Medical Devices (Draft for Comment)"
.

 

　　The opinion pointed out that in order to further do a good job in the filing of Class I medical devices, the State Food and Drug Administration organized the "Announcement on Matters Concerning the Filing of Class I Medical Devices " (No.
26, 2014) issued by the former State Food and Drug Administration.
It has been revised to form the "Announcement on Matters Concerning the Filing of Class I Medical Devices (Draft for Comment)", which is now open for comments .

 

　　The announcement highlights the following points:

 

　　1.
Medical device filing refers to the activity that the medical device filing person (hereinafter referred to as the filing person) submits filing materials to the drug regulatory department in accordance with legal procedures and requirements, and the drug regulatory department archives the submitted filing materials for future reference
.

 

　　2.
For the domestic first-class medical device filing, the filing person submits filing materials to the department responsible for drug supervision and administration at the city level with districts
.
For the filing of imported Class I medical devices, the filing person submits filing materials to the State Drug Administration
.

 

　　3.
According to the "Class I Medical Device Product Catalog", "In Vitro Diagnostic Reagent Classification Sub-Catalog" (hereinafter collectively referred to as the catalog) and relevant classification and definition notices, if it is determined to be a Class I medical device, the filing person shall go to the corresponding filing department for filing; If it is not included in the catalogue or the relevant classification and definition notice, it shall apply for classification and definition according to the relevant work procedures, and if it is clearly classified as a first-class medical device, it shall go through the recordation with the corresponding recordation department
.
When judging the product management category, it should be based on the actual situation of the product, according to the product description, intended use and product name examples in the "Class I Medical Device Product Catalog", "In Vitro Diagnostic Reagent Classification Sub-Catalog" and other regulations
.

 

　　4.
The filing person shall prepare the product technical requirements for filing medical devices as required
.

 

　　5.
For medical device filing, the filing person shall submit the filing materials in accordance with the requirements of Annex 1 and obtain the filing number
.
The filer shall ensure that the submitted materials are legal, true, accurate, complete and traceable
.

 

　　6.
The filing will be completed after the filing person submits the filing materials that meet the requirements of Annex 1
.
For the filed medical devices, the filing department shall, within 5 working days from the date of filing, publish the information in the "Class I Medical Device Filing Information Form" or the "Class I In Vitro Diagnostic Reagent Filing Information Form" (see Annex 3) relevant information
.

 

　　7.
For a medical device that has been filed, the content of the filing information table and the technical requirements of the filed product change, the filing person shall change the filing to the original filing department, and submit an explanation of the change and relevant documents
.
For medical devices that have been changed and filed, the filing department shall post the changes in the "Changes" column of the filing information form, and announce the relevant information of the changes within 5 working days from the date of the change filing
.

 

　　For products whose product descriptions in the "Class 1 Medical Device Product Catalog" include "should not contain ingredients that exert pharmacological, immunological or metabolic effects", if the ingredients are changed, the filer shall cancel the original filing and apply for another filing
.

 

　　8.
The recordation department shall carry out the recordation work in accordance with the operation specification for the recordation of Class I medical devices (see Annex 5)
.

 

　　In addition, the feedback form needs to be returned to the email address: ylqxzc@sina.
cn before March 31, 2022
.
Please indicate "Feedback on filing announcement" in the subject of the email
.