Traditional Culture Encyclopedia - Traditional stories - Where is the national medical product filing?

Where is the national medical product filing?

I only heard that the first type of medical devices are subject to filing management, Chinese medicine preparations need to be filed, and other medical products are subject to registration management.

A class of medical devices shall be filed in the local municipal drug and food supervision and administration department.

The State Food and Drug Administration of the United States has made it clear that provincial food and drug administrations are responsible for establishing the information platform for filing traditional Chinese medicine preparations, and medical institutions should fill in complete filing materials through the information platform of local provincial food and drug administrations. The platform will automatically disclose the basic information of traditional Chinese medicine preparation filing, such as preparation name, medical institution name and filing number, while the internal control preparation standards, prescriptions, excipients, process parameters and other information in traditional Chinese medicine preparation filing will not be disclosed. A medical institution shall obtain a Pharmaceutical Preparation Permit for Medical Institutions when preparing traditional Chinese medicine preparations. Those who are not qualified can entrust qualified units to prepare, but at the same time they must file with the provincial food and drug supervision and administration department where the entrusting party is located.