This is the Fujian Province operating type, I hope to help you.
Opening a method of person medical device business enterprises, must be to the municipal food and drug supervision and management department (hereinafter referred to as the Municipal Bureau) to submit an application for "medical device business enterprise license". The applicant in accordance with the provisions of the completion of the medical device business enterprise preparation, acceptance of qualified, the provincial bureau review issued "medical device business enterprise license".
I, apply for legal person medical equipment business enterprise procedures, deadlines flow chart:
According to the prescribed conditions for the preparation of the establishment of the start-up application
15 working days
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Municipal Bureau of the organization of the on-site inspection and acceptance, and qualified to report to the Provincial Bureau
15 working days
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Review the qualified provincial bureau to make a licensing decision
District food and drug supervision and management departments in the receipt of the opening of the applicant's medical device business enterprise within 15 working days from the date of application, according to the Fujian Food and Drug Administration formulated the "Fujian Provincial Medical Devices Business Enterprise Qualification
Provisional Provisions for the Recognition of the qualifications of the provincial medical device business enterprise," the organization of the review and on-site acceptance. Qualified reported to the provincial bureau, the provincial bureau in 15 working days to make a decision on whether to issue a "medical device business enterprise license", within 10 days of the issuance of the "medical device
device business enterprise license"; acceptance failed, issued by the "decision not to administrative licensing".
Second, the application for legal persons to operate medical equipment business conditions:
(a) 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;
(B) with the scale and scope of operation of relatively independent premises;
(C) with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
(D) should be (D) should establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(E) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
In the application for "medical device business enterprise license" on-site acceptance, must pass the acceptance of the organization based on the "Interim Provisions for the Recognition of Qualifications of Medical Device Business Enterprises in Fujian Province"
Third, the applicant is required to submit a directory of materials (in duplicate):
1, the medical device business enterprise license application form
(1) medical device business Enterprise License Application Form
(2) medical device business license application form should be filled out in accordance with the requirements of filling instructions.
2, business name pre-approval notice or a copy of the business license
If a new business, submit a copy of the pre-approval notice of the business name; if the company has increased the scope of submission of a copy of the business license.
3, the legal representative, the person in charge of the enterprise basic information, a copy of ID card; quality management personnel, after-sales service personnel basic information and academic qualifications or title certificate copy;
Corporate representative, the person in charge of the enterprise resume and stamped or signed copy of ID card.
Quality management personnel, after-sales service personnel resume and seal or signature of the academic or professional title certificate copy.
4, the basic situation of the start-up unit
Basic introduction should include the proposed business premises, warehouses, the basic situation of personnel, the configuration of the quality management personnel whether or not the scope of business is appropriate. The organization chart of the enterprise and its related functions, the after-sales service that the enterprise can provide, the proposed operation of the main types of categories (according to the "Medical Devices Classification Catalogue") and so on.
5, the enterprise registered address, warehouse address
Submit the enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the functional areas and the corresponding area), stamped or signed proof of ownership of the house (or proof of ownership of the house + lease agreement) copy.
6, the enterprise product quality management system documents and storage facilities, equipment catalog
Submit the enterprise should have a quality management system document catalog and storage facilities, equipment catalog
7, the applicant on the declaration of authenticity of the materials
(1) the list of materials submitted;
(2) the enterprise's commitment to bear the legal responsibility;
(3) stamped or proposed legal representative signature.
The above application materials submitted by the unified use of A4-type paper, and bound, where the submission of materials for copies should be stamped with the applicant's original seal or signature.
Enterprises should log on to the Fujian Provincial People's Government Portal while filing paper application materials, and file an electronic version of the application materials online.
Four, based on:
1, "Supervision and Administration of Medical Devices Regulations" Article 24
2, the State Food and Drug Administration "Medical Device Business License Management Measures" (Bureau Decree No. 15).
3, "Fujian Province, the medical device business enterprise qualification recognition of the Interim Provisions"
V. Description:
Corporate medical device business enterprise "medical device business enterprise license" to change the licensing matters, should be to the district municipal bureau to apply for change, without the approval of the provincial bureau, shall not change the licensing matters; legal person of the medical device business enterprise to change the registration
Matters of the business sector should be approved within 30 days after the change, to the regional municipal bureau to apply for change. Medical Device Business License" has a limited period of five years, the enterprise shall apply for re-examination of the license six months before the expiration of the limited period.
Sixth, the application form model text:
"Medical Device Business License" application form.doc
If you still want to know more about the city related to the official website of Freeda can be consulted.