Announcement of the State Drug Administration on the relevant matters of the first category of medical device records

Announcement of the State Drug Administration on the relevant matters of the first category of medical device records

(2022 No. 62)

In order to do a good job in the filing of the first type of medical device, in accordance with the "Regulations on the Supervision and Administration of Medical Device" (State Council No. 739), "Measures for the Management of Medical Device Registration and Records" The Management Measures for the Registration and Record of Diagnostic reagents (Order No. 48 of the State Administration of Market Supervision and Administration), the relevant matters of the first category of medical devices (including the first type of in vitro diagnostic reagent) are announced as follows:

I. Medical equipment filing refers to the campaign to submit the filing materials to the drug supervision and management department in accordance with the legal procedures and requirements, and the drug supervision and management department shall submit the filing materials submitted for the filing of the filing information in accordance with the legal procedures and requirements.

2. The first category of medical device filing in the domestic type, and the recorder submits the filing information to the municipal -level municipal level responsible for drug supervision and management. Imported the first category of medical equipment for filing, and the recorder submitted the filing information to the State Drug Administration.

3. When determining the product management category, it shall be based on the actual situation of the product and determine the description, expected use and product name as the "First Category of Medical Device Product Catalogs" and "Endogenic Diagnostic Reaging Reagents Catalogs".

According to the "First Category of Medical Device Product Catalog" "In vitro Diagnosis Reaging Reagent Catalog" (hereinafter collectively referred to as the catalog) and the results of the relevant classification definition as the first type of medical device, the recorder shall apply for the filing department for the corresponding filing department; exceeding the directory exceeds the directory The content of the content is defined according to the relevant working procedure application, and the first type of medical equipment is clearly required to apply for the record to the corresponding filing department.

Fourth, to handle the filing of medical equipment, the recorder shall submit the filing information of the compliant requirements (see Annex 1), fill in the filing form (see Annex 2), and get the filing number. The recorder shall ensure that the submitted information is legal, authentic, accurate, complete and traceable.

5. The recorder submits the filing information that meets the requirements of Annex 1 and completes the filing. For the medical device that records the filing department, the filing department provides the filing number (see attachment 3) to the recorder (see the notice of the filing number), and publish the "First Class of Medical Device File Information Forms" or "First Category of Eye Diagnostic Reagent Record Information Form" at a prescribed time. Table "(see Annex 4).

6. The recorded medical device that has been recorded and the technical requirements of the contents of the filing information form and the technical requirements for filing have changed. The recorder shall change the filing to the original filing department and submit the explanation of the changes and related documents. For medical devices that have been recorded, the filing department shall board the changes in the filing information table "Change" column, and publish information related to the change of changes according to the prescribed time.

7. The filing department shall carry out the filing work in accordance with the first type of medical equipment filing operation (see Annex 5).

8. The arrangement of the first category of medical device filing number is:

× 1 ×××× 2 ×××× 3. in:

× 1 is the abbreviation of the place where the filing department is:

Imported first type of medical equipment is the word "country";

The first category of medical devices in the country is the abbreviation of the municipal administrative area where the provinces, autonomous regions, and municipalities are located in the province, autonomous region, and municipality in the country (no city, autonomous region, and municipality in the municipal administrative area of ​​the city -level administrative areas in the place where they are located);

×××× 2 is the year of the filing;

×××× 3 is the filing flow number.

9. The State Drug Administration establishes the filing information platform to bring together the first type of medical equipment filing information; the provincial pharmaceutical supervision and management department is responsible for the collection and submission of the filing information of the first category of medical device in its own jurisdiction. For the filing, the filing department shall publish the relevant information published in the filing information form on its website in accordance with the prescribed time. platform.

For changes to the filing, the change of the filing department will be put on the change of the filing information table change. According to the prescribed time, the relevant information of the change filing is announced. The filing information should be reported to the information platform for the filing of the State Drug Administration in time.

This announcement will be implemented from the date of issuance. The "Announcement on the Related Matters of the First Class of Medical Equipment Dispute Records" (No. 26, 2014) issued by the former State Food and Drug Administration was abolished at the same time.

Special announcement.

Attachment: 1. Requirements and instructions for the first category of medical device record data

2. The first category of medical device filing form (format)

3. Notification of the first category of medical device filing number

4. The first category of medical equipment filing information table and first type of in vitro diagnostic reagent filing information table

5. The first type of medical device filing operation specifications

State Drug Administration

August 10, 2022

appendix:

1. Requirements and instructions for the filing data of the first category of medical equipment

2. The first category of medical device filing form (format)

3. Notification of the first category of medical device filing number

4. The first category of medical equipment filing information table and first type of in vitro diagnostic reagent filing information table

5. The first type of medical device filing operation specifications

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