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Announcement of the State Food and Drug Administration on Matters Concerning the Filing of Class I Medical Devices

 Last Update: 2022-08-20
 Source: Internet
 Author: User

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In order to do a good job in the filing of Class I medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (Order No.
739 of the State Council), "Administrative Measures for Registration and Filing of Medical Devices" (Order No.
47 of the State Administration for Market Regulation), Measures for the Administration of Registration and Filing of Diagnostic Reagents (Order No.
48 of the State Administration for Market Regulation), the matters concerning the filing of Class I medical devices (including Class I in vitro diagnostic reagents) are hereby announced as follows:

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.
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
.

If it is determined to be a Class I medical device 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 results, the filer shall file with the corresponding filing department; If the content is classified and defined according to the relevant work procedures, if it is clearly classified as a first-class medical device, it shall be filed with the corresponding filing department
.

4.
For medical device filing, the filing person shall submit the filing materials that meet the requirements (see Appendix 1), fill in the filing form (see Appendix 2), and obtain the filing number
.
The filer shall ensure that the submitted materials are legal, true, accurate, complete and traceable
.

5.
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 provide the filing number with the filing number (see Annex 3 for the notification of filing number), and publish the "Class I Medical Device Filing Information Form" or "Class I In Vitro Diagnostic Reagent Filing Information" according to the prescribed time.
The relevant information published in the Table” (see Annex 4)
.

6.
For medical devices that have been filed, if the contents of the filing information table and the technical requirements of the filed products have changed, the filing person should change the filing to the original filing department, and submit an explanation of the changes and relevant documents
.
For a medical device that has been changed for filing, the filing department shall post the change in the "Change" column of the filing information form, and announce the relevant information on the change within the prescribed time
.

7.
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)
.

　　8.
The arrangement of the record number of the first class medical device is as follows:

　　×1Mechanical equipment××××2××××3
.
in:

　　×1 is the abbreviation of the location of the filing department:

　　Imported first-class medical equipment is the word "country";

　　The domestic first-class medical device is the abbreviation of the province, autonomous region, and municipality directly under the Central Government where the filing department is located plus the abbreviation of the city-level administrative region divided into districts (if there is no corresponding city-level administrative region divided into districts, it is only the abbreviation of the province, autonomous region, and municipality directly under the Central Government);

　　××××2 is the filing year;

　　××××3 is the record serial number
.

　　9.
The State Food and Drug Administration establishes a filing information platform to collect the filing information of Class I medical devices; the provincial drug administration is responsible for the collection and submission of filing information for Class I medical devices
within its jurisdiction .
For filing, the filing department shall publish the relevant information in the filing information form on its website according to the prescribed time, and the provincial drug supervision and administration department shall promptly report the filing information of domestic Class I medical devices to the State Drug Administration as required.
platform
.

　　For changes to the filing, the filing department will post the changes in the change column of the filing information table, and publish the relevant information about the filing changes on its website at the specified time.
The filing information shall be reported to the filing information platform of the State Drug Administration in a timely manner
.

　　This announcement shall come into force on the date of publication
.
The "Announcement on Matters Concerning the Filing of Class I Medical Devices" (No.
26 of 2014) issued by the former State Food and Drug Administration shall be repealed at the same time
.

　　Hereby announce
.

　　Attachment: 1.
Requirements and descriptions for filing materials for the first class of medical devices

　　2.
Class I medical device filing form (format)

　　3.
Notification of the first class medical device filing number

　　4.
Information Form for Filing of Class I Medical Devices and Information Form for Filing of Class I In Vitro Diagnostic Reagents

　　5.
Code of Practice for the Filing of Class I Medical Devices

　　State Food and Drug Administration

　　August 10, 2022

　　7.
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)
.

　　8.
The arrangement of the record number of the first class medical device is as follows:

　　×1Mechanical equipment××××2××××3
.
in:

　　×1 is the abbreviation of the location of the filing department:

　　Imported first-class medical equipment is the word "country";

　　××××2 is the filing year;

　　××××3 is the record serial number
.

Medicines Medicines Medical Devices Medical Devices

　　Hereby announce
.

　　Attachment: 1.
Requirements and descriptions for filing materials for the first class of medical devices

　　Attachment: 1.
Requirements and explanations for filing materials for Class I medical devices

　　2.
Class I medical device filing form (format)

　　2.
Class I medical device filing form Class I medical device filing form Class I medical device filing form (format) (format) (format)

　　3.
Notification of the first class medical device filing number

　　3.
Notification of filing number for the first class of medical devices

　　4.
Information Form for Filing of Class I Medical Devices and Information Form for Filing of Class I In Vitro Diagnostic Reagents

Class I Medical Device Filing Information Form and Class I In Vitro Diagnostic Reagent Filing Information Form Class I Medical Device Filing Information Form and Class I In Vitro Diagnostic Reagent Filing Information Form Reagent filing information form

　　5.
Code of Practice for the Filing of Class I Medical Devices

　　5.
Code of Practice for the Filing of Class I Medical Devices Code of Practice for Filing of Class I Medical Devices

　　State Food and Drug Administration

　　August 10, 2022

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