On March 2, the Comprehensive Department of the SFDA issued a public solicitation for comments on the Notice concerning The Filing of Category I Medical Devices (Draft).

Opinions, points out that in order to further do a good job in class I medical devices for the record state food and drug administration organization of the state food and drug supervision and administration bureau issued "on the first category of medical apparatus and instruments for the record relevant matters announcement no. 26 (2014) revision, formed on the class I medical devices for the record the announcement of relevant matters (draft)", It is now open for comment.

The announcement highlights the following points:

1. Archival filing of medical devices refers to the activities of a medical device archival filing person (hereinafter referred to as the archival filing person) who submits archival filing materials to the drug regulatory department in accordance with legal procedures and requirements, and the drug regulatory department files the submitted archival filing materials for future reference.

For the filing of category I medical devices within the territory of China, the person making the filing shall submit the filing materials to the drug supervision and administration department of the city divided into districts. The importer of category I medical devices shall submit the materials for archival filing to the State Medical Products Administration.

Iii. If category I medical devices are determined in accordance with Category I Medical Device Product Catalogue, Sub-Catalogue of Classification of In Vitro Diagnostic Reagents (hereinafter referred to as catalogue) and relevant classification definition notice, the archival filing person shall handle archival filing with the corresponding archival filing department; If the medical device is not included in the catalog or the relevant classification definition notice, it shall apply for classification definition according to the relevant working procedures and be clearly identified as category I medical device, and go through the filing with the corresponding filing department. When determining the product management category, it shall take into account the actual situation of the product and give examples of the product description, intended use and product name in the Product Catalog of Category I Medical Devices and The Subcatalog of Classification of In Vitro Diagnostic Reagents.

The archival filing person shall, as required, compile the product technical requirements of the medical devices for archival filing.

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

6. The record holder shall complete the record after submitting the record materials in accordance with the provisions of Annex 1. For the archival medical devices, the archival filing department shall, within 5 working days from the date of archival filing, publish the relevant information in the Archival Filing Information Form for Category I Medical Devices or The Archival Filing Information Form for Category I In-vitro Diagnostic Reagents (see Appendix 3).

7. If the contents in the archival information form and the product technical requirements for archival filing of a medical device have changed, the archival filing person shall change the archival filing to the original archival filing department, and submit explanations of the changes and relevant documents. The archival filing department shall record the changes in the column of "Changes" in the archival filing information form, and publish the relevant information of the changes within 5 working days from the date of the changes.

For the products whose product description in Category I Medical Devices Product Catalogue contains "ingredients that should not contain pharmacological, immunological or metabolic effects", if the ingredients involved are changed, the record holder shall cancel the original record and apply for another record.

Viii. The archival filing department shall carry out the archival work in accordance with the operating standards for archival filing of Category I medical devices (see Appendix 5).

In addition, the feedback form should be returned to ylqxzc@sina.cn by March 31, 2022. Note The subject of the email is "Feedback for Record announcement".