Applicants submit materials du directory
1, "medical device business zhi enterprise license application form" dao, "medical device business enterprise license".
2, the administrative department for industry and commerce issued a "notice of pre-approval of enterprise name" or "industrial and commercial business license.
3, application report.
4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificate.
5, business premises, warehouse layout plan.
6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality manager's identity card, a copy of the certificate of academic qualifications or title certificate and personal resume.
7, list of technical staff and copies of academic and professional title certificates.
8, operating quality management specification document catalog.
9, the enterprise has installed the product purchase, sale, inventory information management system, print information management system home page.
10, storage facilities and equipment catalog.
11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the directory of application materials and the enterprise to the material to make a commitment to bear legal responsibility if false;
12, where the application for the enterprise to declare the material, the processing staff is not the legal representative or person in charge of the person himself, the enterprise should submit the "power of attorney.
13, apply for a "medical device business license" confirmation letter
Requirements for applying for a medical device business license materials:
1, business enterprises to submit the "Medical Device Business License Application" should be signed by the legal representative or stamped with the official seal of the enterprise;
2, the "Medical Device Business License Application" by the Fill in the project should be filled out complete and accurate, fill in the content should meet 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, the quality of the person in charge of the 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 text description, 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, photocopies on A4 paper, according to the order of the catalog of application materials in a bound volume.
Extended information
Medical device license period
"Medical Device Business License" is valid for five years. The expiration of the validity period, the need to continue to operate medical equipment products, medical equipment business enterprises should be in the validity of the expiration of six months before, to the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to apply for reissue of the "medical equipment business enterprise license".
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the provisions of the renewal application for review.
Provinces, autonomous regions and municipalities (food) drug supervision and management departments should be in the "medical device business license" before the expiration of the validity of the decision on whether to grant its renewal. Late decision is not made, deemed to agree to renew the license and to make up the appropriate procedures.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department that meets the requirements, should be in the "medical device business license" shall be issued when the expiration of the new license, to retrieve the original "medical device business license";
does not meet the conditions, should be rectified, rectification is still not in line with the conditions, it should be written off in the validity of the original "medical device business license", and inform the applicant in writing. Business Enterprise License", inform the applicant in writing and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
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