The operation of Class II medical devices now only need to do the record, do not need to apply for a license.
According to the "Supervision and Administration of Medical Devices" (State Food and Drug Administration Decree No. 8) issued by the State Food and Drug Administration on July 30, 2014
Article VIII of the third class of medical equipment business, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district and submit the following information:
(a) a copy of the business license and organization code certificate;
(b) legal representative, the person in charge of the enterprise, the person in charge of quality of the identification, education or title certificate;
(c) organizational structure and departmental setup description;
(d) the scope of business, the business mode description;
(e) the business premises, storehouse Address of the geographic location map, floor plan, documents certifying the ownership of housing or lease agreement (with documents certifying the ownership of housing) copies;
(vi) business facilities, equipment catalog;
(vii) business quality management system, work procedures and other documents catalog;
(viii) computer information management system basic information and functional description;
( (ix) proof of authorization of the operator;
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. Extended information:
Requirements for the application materials
1, the business enterprise to submit the "Medical Device Business License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise;
2, the "Medical Device Business License Application Form" filled out the items should be filled out completely and accurately, fill in the content should be consistent with the following requirements.
A, "business name", "registered address" and "industrial and commercial business license" or "pre-approved notice of enterprise name" is the same.
B, to apply for the business scope of the State Drug Administration in 2002 issued by the "Classification of Medical Devices Catalog" a directory to fill out.
C, "registered address", "warehouse address" should be filled out specific door, floor and room number.
3, the legal representative's identification, proof of academic title, appointment documents should be valid;
4, industrial and commercial administration issued by the "pre-approval of enterprise name notification" or "business license" copy should be the same as the original, the copy to confirm the retention of the original is returned;
5, real estate certificates, proof of rental of premises (the lessor to provide proof of property rights) should be valid;
5, real estate certificates, proof of rental of premises (the lessor to provide proof of property rights) should be valid;
6, the person in charge of the enterprise, quality management resume, proof of education or title should be valid;
7, the enterprise should be based on their own actual establishment of medical device quality management files or forms.
8, the self-assurance statement of the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the enterprise, or if there is no official seal, then the legal representative must be signed or signed in person.
9, where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy of the words "this copy is consistent with the original" or a description of the words, indicate the date, and stamped with the official seal of the unit; personal application shall be signed or stamped.
10, the application materials should be complete, clear, signed, and stamped copy by copy, all application forms computer typing to fill out, print on A4 paper, photocopy on A4 paper, according to the order of the catalog of application materials in a bound volume.
/baike.baidu.com/item/%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%BB%8F%E8%90%A5%E8%AE%B8%E5%8F%AF%E8%AF%81/4712342?fr=aladdin" target="_blank "title="Only support when a link is selected to take effect">Baidu Encyclopedia - Medical Device License