To operate Class II medical devices, you must first have a business license of the company. Then, the second-class medical devices to be operated by the company need to be compiled into Excel tables, which contain the product names and specifications of Tian Ming products and the second-class classification to which the registration number belongs. Should be stamped with the official seal, and then log on to the website of the State Food and Drug Administration, and register the company name, and then apply for the filing of Class II medical devices on the website.

After filling out the application form, print out the form together with a copy of the business license, the power of attorney of the legal person, and a copy of the second-class medical device commodity registration certificate, affix the seal, and submit the statistical summary to the designated drug administration or the market management pharmacy department for paper review.

After the audit is completed and confirmed, upload the data to the system. SFDA will then print the filing form for Class II medical devices. Only when the business license and the second-class filing form are complete can the second-class medical devices be sold.

What does the second-class medical device registration certificate mean?

According to the Regulations on the Supervision and Administration of Medical Devices, it is necessary to apply for the Record Certificate of Class II Operation of Medical Devices, which is valid for five years, and the application for renewal must be made six months in advance.

How to prepare for the filing of the first, second and third types of medical devices?

20 1 June, 41A few days ago, if the business license for Class II medical devices has been obtained, there is no need to re-apply for filing. If the business license expires and it is necessary to continue to engage in business, it shall be filed.

20 1 April1The food and drug supervision and administration department that has accepted the application for the business license of Class II medical devices shall notify the enterprise to handle the filing in accordance with the new regulations.

What materials do I need to apply for Class II medical devices?

The second-class medical device business now only needs to be filed, and no license is required.

According to the Measures for the Supervision and Administration of Medical Device Management (Order No.8 of China Food and Drug Administration) issued by China Food and Drug Administration on July 30, 20 14.

Article 8 To engage in the operation of Class III medical devices, the operating enterprise shall apply to the municipal food and drug supervision and administration department located in the district, and submit the following materials:

(a) a copy of the business license and organization code certificate;

(two) the legal representative, the person in charge of the enterprise and the person in charge of quality, and a copy of the certificate of education or professional title;

(three) the description of the organization and department;

(4) Description of business scope and mode of operation;

(5) A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address;

(6) Catalogue of business facilities and equipment;

(seven) management quality management system, working procedures and other documents;

(eight) the basic introduction and functional description of the computer information management system;

(9) the authorization certificate of the agent;

Extended data:

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 identity certificate, education certificate, professional title and appointment document of the legal representative shall be valid;

4, issued by the administrative department for Industry and commerce "enterprise name pre-approval notice" or "business license" copy should be the same as the original, copy confirmed retained, the original returned;

5. Property right certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid;

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 the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date 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.

How long can I declare medical devices with Class II certificates?

It takes 1-2 working days to apply for the second-class medical device license, with complete information, basic information and qualification certificates of the legal representative and person in charge of the enterprise, notice of pre-approval of the enterprise name issued by the administrative department for industry and commerce, resume, education or title certificate of the person in charge of production quality and technology of the enterprise, registration form of relevant professional and technical personnel and workers, proportion of senior and intermediate junior technicians, production site certification documents and other relevant information.