Medical device company registration process:
Application conditions: warehouse area 15㎡ or above, and office area of 30㎡ or above.
The layout is guided by the agent according to the requirements of the Food and Drug Administration.
The first step is to check the industrial and commercial name.
Materials required:
1. Name Pre-approval Application
2. Identification certificate of the investor
3. Registered capital and contribution ratio
Processing time: 3 working days with complete materials and no duplicate names.
Step 2 Application for License of Medical Device Business Enterprise
1. Accept notification
Materials required:
1 Registration Form of Application Materials for Medical Device Business License;
2 "Shanghai Medical Device Business License Application Form";
3. A copy of the certificate of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce;
4. A copy of the ID card, education or professional title certificate and resume of the person in charge of enterprise quality management to be established;
5. A copy of the ID card, education or professional title certificate of the quality management personnel of the enterprise to be established;
(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;
7. The registered address of the proposed enterprise, the geographical location map and floor plan of the warehouse address, the marked area, the property right certificate of the house or a copy of the lease agreement with the property right certificate of the leased house;
8. The product quality management system 1 1 document of the proposed enterprise, and the catalogue of storage facilities and devices;
The business scope of the proposed enterprise shall be determined according to the management category and category code name specified in the Catalogue of Medical Devices Classification;
10 business license, copy of product registration certificate and power of attorney of the entrusted seller of the products to be sold;
10 electronic application materials; Demand for drug testing in Pudong;
1 1 Other documents that need to be provided.
Attachment: Specific requirements of application materials:
1 The form must be complete and clear.
At the same time, the electronic text of the application form should be put on floppy disk, and A4-size fax paper should not be submitted as a copy of the information.
The application materials submitted by the applicant shall be complete, standardized and effective.
2. Medical device business enterprise license
1 After approval, the drug inspection department will conduct on-site inspection within 25 working days.
2. Issue the medical device business license within 10 working days from the date of making the decision to grant the license.
Processing time: 25 working days after the materials are complete and accepted.
Step three, industrial and commercial registration.
Materials required:
1. Power of attorney of the designated representative or entrusted agent of all shareholders and a copy of the client's work permit or ID card;
2. Notice of pre-approval of enterprise name;
3, the shareholder's legal person qualification certificate or natural person identity certificate;
4. An application for registration of the establishment of an enterprise as a legal person signed by the company's chairman or executive director;
5. The shareholders' meeting decides that the shareholders shall affix their seals and the natural person shareholders shall sign them;
6. The resolution of the board of directors shall be signed by all directors;
7. The articles of association of the company shall be sealed by all shareholders, and the group limited company shall also submit the articles of association of the group with the seals of the group member enterprises;
8. Records showing the names and residences of directors, supervisors and managers of the company, as well as certificates of appointment, election or employment, including:
1 letter of appointment is wholly state-owned;
2. The letter of appointment shall be sealed by the appointing unit;
3. Certificate of appointment of the company's chairman or executive director, director, supervisor and manager;
4. Copies of ID cards of directors, supervisors and managers of the company;
9. A capital verification report issued by a legally qualified capital verification institution;
10, the company's residence certificate, and the lease agreement with a copy of the property right certificate is required for renting a house;
1 1. In the business scope of the company, if it is a project that must be approved according to laws and administrative regulations, the approval documents of relevant departments shall be submitted;
12. If the establishment of a limited liability company is subject to approval according to laws and administrative regulations, the approval documents of relevant departments shall be submitted;
13, a full set of application forms and other materials issued by our bureau.
Processing time: 5 working days after the materials are complete.
Cost: It depends on the registered capital.
Step 4: Mechanism Code
Materials required:
1. Original and photocopy of business license
2. Identification certificate of the legal representative
Processing time: usually 5 working days; The expediting time is 1 working day.
Step 5: Tax registration
Required materials: same as industrial and commercial materials.
Additional requirements:
1, 4 copies of tax registration form
2. Organization Code Certificate
Two sets of the above materials are required.
Processing time: complete materials 15 working days.
Medical device business license administrative license
Contents of administrative license
1. Review and issue the newly issued Medical Device Business License, Class II Medical Device License and Class III Medical Device License.
2, the second and third types of medical device business enterprises merger, division or migration across the original jurisdiction.
Legal basis for setting authority
1, Regulations on the Supervision and Administration of Medical Devices;
2. Measures for the administration of licenses of medical device enterprises
Specific matters of administrative licensing conditions
1, the legal representative of the enterprise, the person in charge of the enterprise, and the quality management personnel shall not have the circumstances specified in Article 40 of the Regulations on the Supervision and Administration of Medical Devices;
2. An enterprise shall have a quality management organization or full-time quality management personnel suitable for its business scale and scope; Quality management personnel should have relevant professional qualifications or titles recognized by the state, and have professional and technical personnel who have obtained qualifications according to law. If the quality manager should be at work, not in other units.
3. It has a relatively independent business place suitable for its business scale and scope.
4. Having storage conditions, storage equipment and facilities suitable for the business scale and scope.
5. Ability to provide technical training and after-sales service for products.
6, should according to the relevant provisions of the state and local, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards, industry standards and regulations, rules and special provisions of the supervision and management of medical devices.
8, in accordance with the "Guangdong Province set up medical device business enterprise acceptance implementation standards" for acceptance.
List of materials submitted by the applicant
Data number 1, medical device business license application form, medical device business license.
2. Notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce.
No.3, application report.
4. Proof documents of the business premises and storage premises, including the copy of the title certificate or lease agreement and the title certificate of the lessor.
Data 5. Layout of business premises and warehouses.
The ID card, diploma or title certificate copy and resume of the person in charge of the proposed employment method, the person in charge of the enterprise and the quality manager in No.6 document.
List of No.7 technicians and copies of their academic qualifications and titles.
Data No.8. Directory of Management Quality Management Specification Documents.
Data No.9. Product Invoicing Information Management System installed by the enterprise, and the homepage of the information management system is printed.
The material number is 10, and the storage facilities and devices are listed.
Data number 1 1, announcement of on-the-job self-assurance of quality management personnel and announcement of self-assurance of authenticity of application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood;
The material number is 12. If the handler of enterprise application materials is not the legal representative or the person in charge himself, the enterprise shall submit a power of attorney.
MaterialNo. 13, Application for Medical Device Business License Confirmation
Requirements of application materials
1. The Application Form for Medical Device Business License submitted by the business enterprise shall be signed by the legal representative or stamped with the official seal of the enterprise;
2, the medical device business license application form to fill in the project should be complete and accurate, fill in the content should meet the following requirements.
The "enterprise name" and "registered address" are the same as the industrial and commercial business license or the notice of pre-approval of enterprise name.
B the business scope for application shall be filled in according to the Class I Catalogue of Medical Devices issued by the State Medical Device Administration in 2002.
C, "registered address" and "warehouse address" should fill in the specific house number, floor and room number.
3, the legal representative's identity certificate, certificate of education and professional title, employment documents should be valid;
4 issued by the administrative department for Industry and commerce "enterprise name pre-approval notice" or "business license" copy should be consistent with the original, the copy confirmed to be retained, the original returned;
5. If the lessor wants to claim the right of * * * *, it shall be valid with the property right certificate and the house lease certificate;
6, the person in charge of the enterprise, the quality manager's resume, diploma or title certificate should be within the validity period;
7, enterprises should establish medical device quality management documents or forms according to their own reality.
8. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. If there is no official seal, it shall be signed or sealed by the legal representative himself.
9. If a photocopy of the application materials is required, the applicant shall indicate the words "This photocopy is consistent with the original" or a written description on the photocopy, date it and affix the official seal of the unit; Individual applications should be signed or sealed.
10. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be typed and filled in by computer, printed on A4 paper, copied on A4 paper, and bound in the order of application materials.
Legal liability
1. If the applicant conceals relevant information or provides false materials to apply for the Medical Device Business License, the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government or the entrusted food and drug supervision and administration department of the city with districts will not accept the application or issue the Medical Device Business License and give a warning. The applicant shall not apply for the Medical Device Business License again within 1 year.
2. If the applicant obtains the medical device business license by cheating, bribery or other improper means, the food and drug supervision and administration department shall revoke its medical device business license, give a warning and impose a fine of 6,543,800 yuan to 20,000 yuan. The applicant shall not apply for a medical device business license again within 3 years.