"Supervision and Administration of Medical Devices Regulations" Article 29 provides that to engage in medical device business activities, there should be with the scale and scope of operation and business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management institutions or personnel. However, the Drug Administration around the record information requirements are not the same, you need to consult the local Drug Administration Equipment Division.
The second class, the third class of medical equipment business enterprise merger, separation or migration across the original jurisdiction
Set the legal basis for licensing
1, "Supervision and Administration of Medical Devices Regulations";
2, "Medical Device License Management Measures"
Administrative licensing conditions specific matters
1, the enterprise The legal representative, the person in charge of the enterprise, quality management personnel should be no "supervision and management of medical devices regulations" Article 40 of the circumstances;
2, the enterprise should have with the scale and scope of operation of the quality management organization or full-time quality management personnel; quality management personnel should have a state-recognized relevant professional qualifications or titles, with the qualification of professionals and technicians in accordance with the law. Such as quality management personnel should be on duty, shall not be part-time in other units
3, with the scale and scope of operation of relatively independent business premises.
4, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
5, with the operating products for technical training, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
8, in accordance with the "Guangdong Province to start the medical device business acceptance of the implementation of standards" acceptance.
Applicants submit materials directory
Data No. 1, "Medical Device Business License Application Form", "Medical Device Business License.
Data No. 2, "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the Administration for Industry and Commerce.
Data No. 3, Application Report.
Data No. 4, supporting documents for business premises and warehouse premises, including copies of property certificates or lease agreements and property certificates of the lessor.
Data No. 5, business premises, warehouse layout plan.
Data No. 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.
Data No. 7, a list of technical staff and copies of academic and professional title certificates.
Data No. 8, business quality management standardized document catalog.
Data No. 9, the enterprise has been installed in the product purchase, sale, inventory information management system, print information management system home page.
Data No. 10, storage facilities and equipment catalog.
Data No. 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;
Data No. 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 "letter of authorization .
Data No. 13, apply for a "medical device business license" confirmation
Requirements for the application materials
1, business enterprises 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" 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 confirms to retain, the original returned;
5, proof of property, proof of rental of housing (the lessor to provide title Proof) 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 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, photocopies on A4 paper, according to the order of the catalog of application materials in a bound volume.
Legal responsibility
1, the applicant to conceal the relevant information or provide false materials to apply for "medical device business license"
the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or accept the entrusted municipal (food) drug supervision and management agencies of the application will not be admissible or will not be issued "medical device business license".
Certificate" and give a warning. The applicant shall not apply for another "medical device business enterprise license" within 1 year.
2, the applicant by deception, bribery and other improper means to obtain "medical device business license", (food) drug supervision and management department shall revoke its "medical device business license", give a warning, and impose a fine of 10,000 yuan or more than 20,000 yuan. The applicant shall not apply again for a "medical device business enterprise license" within three years.