Class II medical device network sales filing process

First, the medical device network trading services third-party platform provider shall obtain the "Internet Drug Information Service Qualification Certificate", with its size of the office space and data backup, fault recovery and other technical conditions, set up a specialized medical device network quality and safety management organization or equipped with medical device quality and safety management personnel.

Second, the preparation of the declaration document, download and fill out the "Medical Device Network Sales Information Form".

Third, with the "supervision and management of the sale of medical devices network approach" required by the relevant materials to the local provincial drug supervision and management department for the record.

Fourth, by the drug regulatory department on-site verification of materials, in line with the provisions of the record to be issued to the third-party platform for online trading of medical devices record vouchers, the submission of information is incomplete or does not meet the statutory circumstances, should be a one-time notification of the need to supplement the material matters.

Fifth, the third-party platform providers need to accept the provincial drug regulatory authorities within three months after the filing of an on-site inspection.

Through the third-party platform for online sales of medical devices enterprises, need to cooperate with the third-party platform for the production and operation of medical equipment license or filing certificates, medical device registration certificates or filing certificates, business license and other materials for review.

For the second class of medical devices business registration address requirements:

1, office area of not less than 40 square feet; (business building or storefront store);

2, warehouse area of not less than 15 square feet; (my company can provide) (three types of in vitro diagnostic reagents containing a time the need for frozen warehouses);

3, containing three types of disposable supplies, if the request Office address and warehouse area together can not be less than 160 square feet;

If the warehousing entrusted to a third-party logistics company, you need to have a medical device license qualification of the logistics company can.

For the second class of medical devices business filing personnel requirements:

1, with medical equipment, medicine, pharmacy bachelor's degree or above, or intermediate or above technical title 1, as the quality responsible for

2, with high school education or above, as the quality of the administrator;

Legal basis:

Medical device business enterprises License Management Measures" Article 3 of the operation of the second and third class of medical devices should hold a "Medical Device Business Enterprise License", but in the circulation process through routine management can ensure its safety, effectiveness of a few second class of medical devices can not apply for a "Medical Device Business Enterprise License". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.