Required materials:
1, name pre-approval application;
2, investor identification;
3, registered capital, the proportion of capital contribution.
Processing time: 3-5 working days if the materials are complete and the name is not duplicated
The second step of the medical device business license application
1, "Notice of Acceptance"
Required materials:
(1), "Registration Form for Application of Materials for Medical Device Business License";
(2), "Application Form for Medical Device Business License". Shanghai Medical Device Business License Application Form";
(3), the industrial and commercial administration department issued by the enterprise name pre-approval documents or a copy of the "business license";
(4), the proposed enterprise quality management person in charge of the identity card, academic or professional title certificates and copies of the personal resume;
(5), the proposed enterprise quality management personnel Identity card, academic qualifications or certificates of title;
(6), the proposed enterprise organization and functions or full-time quality management personnel functions;
(7), the proposed enterprise registered address, warehouse address of the geographic location of the map, the floor plan (indicating the area), proof of ownership of the house or a copy of the lease agreement (accompanied by a certificate of ownership of the leased premises);
(8), Proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(9), the proposed business scope of the enterprise, in accordance with the medical device classification directory of the management category, class code name to determine;
(10), the proposed sale of products entrusted to the seller's business license and product registration certificate (copy), authorization letter, electronic reporting materials ( Pudong Drug Inspection needs);
(11), other supporting documents to be provided.
Attachment: specific requirements for the application materials:
(1), the content of the form can not be missing, clear handwriting;
(2), at the same time, the electronic copy of the application form (placed on a floppy disk) and A4 specification of the written information (fax paper can not be reported as information) a copy;
(3), the applicant to submit the application materials should be complete, standardized and effective.
2, "Medical Device Business License"
(1), approved for acceptance, within 25 working days of the drug inspection department on-site inspection;
(2), from the date of the decision to grant permission to issue the "Medical Device Business License" within 10 working days.
Processing time: 25 working days after acceptance of complete materials
The third step of industrial and commercial registration
Required materials:
1, all shareholders to designate a representative or *** with the commissioning agent's certificate (power of attorney) and a copy of the commissioned person's work permit or identity card;
2, notice of pre-approval of the name of the enterprise;
3, the shareholders' certificate of legal personality or natural person's identity;
4, the application for registration of establishment of an enterprise legal person signed by the chairman of the board of directors or executive director of the company;
5, the resolution of the shareholders' meeting (shareholders' seal, signature of the natural person shareholders);
6, the resolution of the board of directors (signed by all the directors);
7, the Articles of Association of the company (all shareholders) Seal), group limited company also need to submit the group articles of association (group member enterprises seal);
8, documents setting out the names and residences of the company's directors, supervisors and managers, as well as certificates relating to the appointment, election or employment of the company, which include:
(1), a letter of appointment (wholly owned by the state);
(2), a letter of appointment (seal of the appointing entity);
p>(3), the company's chairman or executive director, directors, supervisors, managers, proof of tenure;
(4), the company's directors, supervisors, managers, a copy of ID cards;
9, with the statutory qualifications of the capital verification agency issued a capital verification report;
10, proof of the company's domicile, leased premises need to be submitted lease agreement (with a copy of the certificate of title);
< p>11, the company's business scope, belonging to the laws and administrative regulations must be submitted to the approval of the project, submit the approval documents of the relevant departments;12, laws and administrative regulations provide for the establishment of limited liability companies must be submitted to the approval, submit the approval documents of the relevant departments;
13, a full set of registration forms and other materials issued by the Bureau.
Processing time: 7 working days after the materials are complete
Labor cost: depends on the registered capital
Step 4 Institutional Code
Required materials:
1, the original and the duplicate of the business license (original and photocopy);
2, the legal representative's identity certificate.
Processing time: normal 5 working days; expedited 1 working day
The fifth step of tax registration
Required materials: the same as industrial and commercial materials
Additionally required:
1, 4 copies of the tax registration form;
2, the institutional code certificate;
Above the materials need 2 sets
Processing time : 15 working days for complete materials
How long is the validity of the license for medical institutions for effective management considerations, according to the establishment of beds (with or without scale, strength), were issued by different validity of the license for the practice of medical institutions, no beds for 5 years, with beds 15 years, the expiration of the period can be within the prescribed period of time to apply for an extension of the formalities.
Legal basis
"Supervision and Management of Medical Devices" Article 10
Engaged in the third class of medical equipment business, the business enterprise shall be located in the area of municipal drug supervision and management department responsible for the application and submit the following information:
1, the legal representative (corporate (person in charge), the quality of the person in charge of identification, education or title copies of relevant materials;
2, enterprise organization and departmental settings;
3, medical device business scope, business mode;
4, business premises and warehouse location map, floor plan, building ownership documents or copies of lease agreements;
5, the main operating Facilities, equipment directory;
6, business quality management system, work procedures and other documents directory;
7, basic information management system;
8, authorization documents.
The applicant for a medical device license shall ensure that the information submitted is legal, true, accurate, complete and traceable.