Hello, medical equipment business license and drug license application by the following steps
Medical equipment business license
Administrative licensing content
1, the review and issuance of the new "medical equipment business license" (second and third class medical devices)
2, the second class, third class medical equipment business enterprise merger, division Or across the original jurisdiction of the relocation of
Legal basis for the establishment of the license
1, "Supervision and Administration of Medical Devices Regulations";
2, "Medical Device License Management Measures"
Administrative licensing conditions specific matters
1, the legal representative of the enterprise, the person in charge of the enterprise, the quality of management personnel should be free of "Supervision and Administration of Medical Devices Regulations" article 40, "Medical Device License Management Measures". Management 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 nationally recognized professional qualifications or titles, with the qualification of professional and technical personnel according to 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 text description, 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 one by one, all application forms computer typing to fill out, print on A4 paper, photocopying 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 the "medical device business enterprise license" within 3 years.
Procedures for applying for the "Drug Business License"
Article 8 The opening of a pharmaceutical wholesale enterprise in accordance with the following procedures for the "Drug Business License":
(a) the applicant to the proposed enterprise location of the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to submit an application for the preparatory work, and submit the following materials:
1. The proposed enterprise Legal representative, the person in charge of the enterprise, the person in charge of quality of the original academic certificate, a copy and biography;
2. licensed pharmacist practice certificate, a copy;
3. The scope of the proposed business drugs;
4. Proposed place of business, equipment, warehousing facilities and the surrounding sanitary environment and other circumstances.
(2) (food) drug supervision and management department of the application made by the applicant, shall be dealt with according to the following circumstances:
1. Application matters do not fall within the purview of the department, it shall be immediate inadmissibility of the decision to be issued to the "inadmissibility of notification", and inform the applicant to the relevant (food) drug supervision and management department to apply for;
2. Application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot;
3. Application materials are not complete or do not meet the statutory form, it should be issued on the spot or within 5 days of the applicant "Notice of Corrective Material", a one-time notification of need to make corrections to all the contents. Late notification, from the date of receipt of the application materials shall be accepted;
4. Application matters within the purview of the department, the materials are complete, in line with the statutory form, or the applicant to submit all the corrective materials as required, issued to the applicant, "Acceptance of the Notice". The date indicated in the Notice of Acceptance is the date of acceptance.
(c) (food) drug supervision and management departments from the date of acceptance of the application within 30 working days, based on the provisions of Article IV of these measures to review the declaration materials, to make a decision on whether to agree to the preparatory work, and notify the applicant in writing. Do not agree with the preparatory work, shall state the reasons, and inform the applicant enjoys the right to apply for administrative reconsideration or administrative litigation according to law.
(d) the applicant to complete the preparatory work, to accept the application of (food) drug supervision and management department to submit an application for acceptance, and submit the following materials:
1. Application for a pharmaceutical license;
2. Industrial and commercial administrative departments issued by the proposed business approval documents;
3. Proposed business organization;
4. business premises, warehouse layout plan and proof of property rights or the right to use the house;
5. According to the qualifications recognized by the pharmacy professional and technical personnel qualification certificates and letters of appointment;
6. Proposed enterprise quality management documents and warehousing facilities, equipment directory.
(E) acceptance of the application (food) drug supervision and management department within 30 working days from the date of receipt of the application for acceptance, based on the implementation of standards for acceptance of the start-up of pharmaceutical wholesale enterprises to organize acceptance, to make a decision on whether or not to issue the "drug license". Qualified, issued to the "drug license"; does not meet the conditions, shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
Article IX to open a retail drug business in accordance with the following procedures for the "Drug License":
(a) the applicant to the proposed business location of the municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management directly set up by the county (food) drug supervision and management agencies to submit the preparatory application, and submit the following materials:
1. the proposed legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality of education, practicing qualifications or title certificate original, copy and resume and professional and technical personnel qualification certificates, letters of appointment;
2. the scope of the proposed business of pharmaceuticals;
3. the proposed place of business, warehousing facilities, equipment.
(d) the applicant to complete the preparatory work, to accept the application of (food) drug supervision and management agencies to submit an application for acceptance, and submit the following materials:
1. Application form for a drug license;
2. Industrial and commercial administration department issued by the proposed business approval documents;
3. Business premises, warehouse layout and housing ownership or Proof of the right to use;
4. Qualification certificates and appointment letters of pharmacy professionals and technicians who have been accredited in accordance with the law;
5. Quality management documents of the proposed enterprise and the main facilities and equipment catalog.
(E) acceptance of the application (food) drug supervision and management agencies in the receipt of the application for acceptance of 15 working
work days from the date of application, based on the establishment of retail drug business acceptance of the implementation of standards for acceptance of the organization, to make a decision whether or not to issue the "drug license". Does not meet the conditions, shall notify the applicant in writing and explain the reasons, at the same time, inform the applicant
Offer the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
Article 10 (food) drug supervision and management department (agency) of the applicant's application for review, found that the administrative licensing matters directly related to the significant interests of others, shall inform the interested party. Acceptance of the department shall hear the applicant, the interested party's statement and defense. Should be heard in accordance with the law, the hearing shall be held in accordance with the provisions of the law.
Article XI (food) drug supervision and management departments (agencies) shall have issued the "drug license" information shall be made public, the public has the right to inspect.
The disclosure of information found after the enterprise in the process of applying for the "drug license", the provision of false documents, data or other deceptive behavior, shall be dealt with in accordance with the law.
Article 12 The Drug Operation License is a legal certificate for enterprises to engage in drug operation activities, and no unit or individual shall forge, alter, buy, sell, lease or lend it.
I hope the above information is helpful to you.