In order to further improve the filing work of Class I medical devices, the State Food and Drug Administration organized the revision of the “Announcement on Matters Concerning the Filing of Class I Medical Devices” (2014 No. 26) issued by the former Food and Drug Administration and issued a new “Announcement on Matters Concerning the Filing of Class I Medical Devices”. The main modifications are as follows:
1. Medical device filing refers to the activity in which 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 domestic Class I medical device registration, the filer shall submit the registration materials to the department responsible for drug supervision and management at the districted municipal level. For registration of imported Class I medical devices, the filer shall submit the registration materials to the State Food and Drug Administration.
3. When determining the product management category, the actual situation of the product should be combined with the product description, intended use and product name examples in the “Class 1 Medical Device Product Catalog”, “In Vitro Diagnostic Reagents Classification Sub-Catalogue” and other regulations.
If a medical device is determined to be a Class I medical device according to the Catalog of Class I Medical Device Products, the Classification Sub-Catalogue of In Vitro Diagnostic Reagents (hereinafter collectively referred to as the Catalog) and relevant classification definition results, the filing party shall apply for filing with the corresponding filing department; if it exceeds the content of the catalog, it shall apply for classification definition according to the relevant work procedures. If it is clearly a Class I medical device, it shall be filed with the corresponding filing department.
4. To handle the registration of medical devices, the filer shall submit the registration materials that meet the requirements (see Attachment 1), fill in the filing form (see Attachment 2), and obtain the filing number. The filer shall ensure that the information submitted is legal, authentic, accurate, complete and traceable.
5. The filing will be completed after the filing party submits the filing materials that meet the requirements of Appendix 1. For registered medical devices, the filing department shall provide the filing number to the filing party (see attachment 3 for notification of filing number), and publish the relevant information published in the “Class I Medical Device Registration Information Form” or the “Class I In Vitro Diagnostic Reagents Registration Information Form” (see attachment 4) according to the prescribed time.
6. For registered medical devices, if the content published in the registration information form and the technical requirements of the registered product change, the filer shall change the registration to the original filing department and submit a description of the change and relevant documents. For medical devices that have been modified for filing, the filing department shall publish the changes in the “Changes” column of the filing information table, and publish relevant information on the changes within the prescribed time.
7. The filing department shall carry out the filing work in accordance with the operating specifications for filing of Class I medical devices (see Appendix 5).
8. The registration number of Class I medical devices is organized as follows:
×1 Equipment××××2××××3. in:
×1 is the abbreviation of the location of the filing department:
Imported Class I medical devices have the word “国”;
Domestic Class I medical devices are the abbreviation of the province, autonomous region, or municipality where the filing department is located plus the abbreviation of the municipal administrative region divided into districts (if there is no corresponding municipal administrative region divided into districts, it is only the abbreviation of the province, autonomous region, or municipality);
××××2 is the filing year;
××××3 is the filing serial number.
9. The State Food and Drug Administration has established a filing information platform to collect filing information for Class I medical devices; provincial drug regulatory authorities are responsible for the collection and submission of filing information for Class I medical devices within their jurisdictions. For filing, the filing department shall publish the relevant information published in the filing information form on its website within the specified time, and the provincial drug regulatory authorities shall promptly report the domestic Class I medical device filing information to the State Food and Drug Administration filing information platform as required.
For changes to the filing, the filing department will publish the changes in the change column of the filing information form, and publish the relevant information on the filing changes on its website according to the prescribed time. The provincial drug regulatory department will promptly report the filing information of changes to the domestic Class I medical devices to the filing information platform of the State Food and Drug Administration in a timely manner as required.
The announcement shall come into effect from the date of issuance. The “Announcement on Matters Concerning the Registration of Class I Medical Devices” (No. 26, 2014) issued by the former State Food and Drug Administration was abolished at the same time.
appendix:
1. Requirements and instructions for filing materials for Class I medical devices
2. Class I medical device registration form (format)
3. Notification of registration number of Class I medical devices
4. Class I medical device registration information form and Class I in vitro diagnostic reagent registration information form
5. Operational specifications for filing of Class I medical devices
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Source: National Medical Products Administration