Does the filing of Class II medical devices require annual review?

Class II medical devicesThe filing does not require annual review. According to Article 13 of the Measures for the Supervision and Administration of Medical Device Production, the validity period of the filing license is 5 years.

At the same time, in accordance with its Article 17 "Medical Device Production License".

If the validity period is extended, the medical device manufacturer shall submit an application for the renewal of the "Medical Device Production License" to the original licensing department 6 months before the expiration of the validity period.

Materials required for the filing of Class II medical devices:

1. The basic information and qualification certificate of the legal representative and the person in charge of the enterprise.

2. Administration for industry and commerce.

Notice of pre-approval of the name of the proposed enterprise.

3. Proof of production site.

4. Resume, academic background or professional title certificate of the person in charge of production, quality and technology of the enterprise; Registration form of relevant professional and technical personnel and skilled workers, and indicate the department and position where they are located; Proportion of senior, intermediate and junior technical personnel.

5. Scope of products to be produced, varieties and related product introduction.

6. Catalogue of main production equipment and inspection equipment.

7. Production quality management.

File directory. 8. Process flow chart of the product to be produced.

The main control items and control points are also indicated.

9. For the production of sterile medical devices, the production environment test report shall be provided.

The above content refers to the Encyclopedia - Measures for the Supervision and Administration of Medical Device Production.

Encyclopedia - Class II medical devices.

It can no longer be operated, and if it is an illegal operation, it will be fined. It is recommended that if you want to continue**, you can apply for a medical device license to find us.

If it is engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the people's government at the municipal level divided into districts where it is located and submit the certification materials that it meets the conditions specified in Article 29 of these Regulations.

Conditions of acceptance. 1. The filing materials should be complete and clear, and those who are required to sign must be signed, stamped with the official seal of the enterprise one by one, printed or copied on A4 paper, bound into a book in accordance with the order of the materials and accompanied by a table of contents;

2. Where a copy of the filing materials needs to be submitted, the applicant must indicate the date on the copy and affix the official seal of the enterprise;

3. The "Class II Medical Device Business Record Form" shall be signed by the legal representative and stamped with the official seal of the enterprise;

4. The items filled in the "Class II Medical Device Business Record Form" should be complete and accurate, and the content should meet the following requirements:

1) "Enterprise name" and "domicile" are the same as business licenses;

2) "Business premises area and warehouse area" shall meet the requirements of the corresponding business scope in the "Implementation Rules for the Supervision and Administration of Medical Device Business in Beijing";

3) In the "mode of operation", "wholesale", "retail" or "wholesale and retail concurrent" is filled in the logic of one of the three choices, and "providing transportation and storage services (wholesale or retail) for medical device registrants, filing persons and business enterprises" can be checked separately without selecting the other three business modes;

Application Materials. 1. A copy of the business license and the ** certificate of the organization.

2. A copy of the identity certificate, academic qualification or professional title certificate of the relevant person in charge.

3. Floor plan of the business premises, copy of the real estate certificate or lease agreement (with the certificate of house ownership).

4. Catalogue of operating facilities and equipment.

5. Catalogue of documents such as business quality management system, work procedures, etc., basic introduction and function description of computer information management system, and authorization certificate of the operator.

1.The business license of the company type shall be obtained in accordance with the law, and its business scope includes the distribution of medical devices, and individual industrial and commercial households cannot apply for a medical device business license or filing. 2.

Have a quality management organization or quality management personnel suitable for the scope and scale of business, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state. Among them: (1) the person in charge of the quality of the medical device business enterprise shall have a college degree or above or an intermediate professional title or above in medical device related majors (related majors refer to medical devices, biomedical engineering, machinery, electronics, medicine, biological engineering, chemistry, pharmacy, nursing, laboratory science, computer, law, management, etc.), and shall have more than 3 years of medical device business quality management experience.

2) Among the quality management personnel engaged in in in vitro diagnostic reagents, one person should be the competent inspector, or have a college degree or above in laboratory science related majors and have more than 3 years of work experience in testing-related work. Personnel engaged in the acceptance and after-sales service of in vitro diagnostic reagents shall have a technical secondary school degree or above in a laboratory related major or have a professional and technical title of a primary or above inspector. (3) Among the personnel engaged in the operation of implantable and interventional medical devices, they shall be equipped with medical-related personnel.

Professional college degree or above, and through the production enterprise or business training personnel. (4) Personnel engaged in the operation of other medical devices with special requirements such as contact lenses and hearing aids shall be equipped with personnel with relevant professional or professional qualifications.

The requirements of the person in charge of quality in medical devices can be based on the provisions of Chapter III of the "Medical Device Business Quality Management Standards" as follows: Article 10 The legal representative, person in charge and quality management personnel of the enterprise shall be familiar with the laws, regulations, rules and regulations of medical device supervision and management and the relevant knowledge of the medical devices operated, and meet the qualification requirements of the relevant laws and regulations and this specification, and shall not be prohibited by relevant laws and regulations. Article 11 The enterprise shall have a quality management organization or quality management personnel suitable for the scope and scale of business, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state.

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Many companies apply for medical device licenses, so how to handle it! What are the requirements and what specific information is required, see below!!

The following information is required in the handling: business license, identity certificate of legal representative, identity certificate of the person in charge of the enterprise, identity certificate of the person in charge of quality, identity certificate is a copy of the front and back of the ID card, the legal person and the person in charge of the enterprise, and the person in charge of quality can be the same person, if the online filing system uploads the scanned copy. The academic certificate of the person in charge of the enterprise and the person in charge of quality is required to be a technical secondary school degree or above in pharmacy and more than 3 years of experience in drug management.

Description of the organization and department setting, description of business scope and business mode, business quality management system, working procedures, geographical location map of the business premises, floor plan of the business premises, proof and copy of the ownership or right to use the business premises, business facilities and equipment directory, enterprise employee roster, and power of attorney for filing.

It seems that it is very troublesome to need a lot of information, but if you entrust it to us, you only need to provide the required identity certificate, academic certificate, etc., and other tedious work can be handed over to us, and we will professionally help you to handle it quickly and legally.

Measures for the Administration of Medical Device Business".

Article 12 If the business is engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the city divided into districts where it is located, fill in the record form for the operation of Class II medical devices, and submit the information specified in Article 8 of these Measures (except for item 8).

Requirements for the filing of Class II medical devices:

1.Have the qualification of a legal person and obtain an industrial and commercial business license or other legal certification issued by the administrative department for industry and commerce in accordance with the law;

3.There are three graduates of medical-related majors with college degree or above, and hold a professional title certificate issued by the relevant department;

4.Product certificates related to operating products.

If it is engaged in the operation of Class III medical devices, the business enterprise shall apply to the food and drug supervision and administration department of the city divided into districts where it is located, and submit the following information:

1.Application for the Filing of Class II Medical Devices in Shanghai;

2.Industrial and commercial business license or pre-approved name notice;

3.Proof of identity of the legal representative;

Proof of identity and professional title of medical professionals;

5.Geographical location map, floor plan, house ownership certificate or lease agreement of business premises and warehouse addresses (except for the address provided by our company);

6.Product business catalogue list;

7.Product Conformity Certificate;

8.purchase and sale contracts and purchase channels;

9.Other materials required by the food and drug administration.

Procedures for the filing of Class II medical device operations.

1) Filing.

1. Acceptance. 1) The filing person directly submits the electronic file and paper file filing materials to the medical device department.

2. Filing on the spot.

If the materials are qualified in the preliminary examination, the filing certificate will be handled on the spot.

3. Information Release.

The medical device department will send the electronic file for filing to the regulatory department for publication, and regularly submit the filing information to the provincial food and drug administration.

2) Change the record.

1) The filing person directly submits the electronic file and paper file filing materials to the medical device department.

2) Review.

2. Filing on the spot.

If the information meets the requirements, the filing certificate will be handled on the spot.

3. Information Release.

Published by the Regulation Department of the local Food and Drug Administration, the Medical Device Department will regularly submit the filing information to the Provincial Food and Drug Administration.

3) Supplemental certificates. 1) The filing person directly submits the electronic file and paper file filing materials to the medical device department.

2) Review.

2. Supplement the certificate on the spot.

If the materials are qualified in the preliminary examination, they will be processed for the record on the spot.

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Legal analysis: The filing materials for Class II medical devices are required: 1. Business license and copy; 2. The identity certificate, academic qualification or professional title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality; 3. List of professional and technical personnel and ID cards, academic certificates and professional title certificates of professional and technical personnel; 4. Description of organizational structure and department setting; Description of business scope and mode of operation; 5. The geographical location map, floor plan, house property right certificate or copy of the housing lease certificate issued by the housing leasing office of the business premises and warehouse address.

If it is a third-party logistics of medical devices entrusted by warehousing, an entrustment contract shall be provided; 6. Catalogue of documents such as management system and working procedures. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality accident reporting system and other documents; 7. Catalogue of operating facilities and equipment; 8. The basic introduction and function description of the computer information management system installed by the enterprise, and the home page of the information management system is printed.

Legal basis: Law of the People's Republic of China on Basic Medical Care and Health Promotion Article 65 The State strengthens the management of medical devices, improves the standards and specifications of medical devices, and improves the safety and effectiveness of medical devices. The competent health departments and the people's health departments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the advancement, suitability and accessibility of technology, prepare large-scale medical equipment allocation plans, and promote the rational allocation and full sharing of medical equipment in the region.

The filing method of Class II medical devices is:

1. Submit an application for filing. The business enterprise shall file with the food and drug supervision and administration department of the city divided into districts where it is located, fill in the second-class medical device business record form, and submit relevant materials;

2) Review. The food and drug supervision and administration department will check the completeness of the information submitted by the enterprise on the spot, and if the application materials are complete and in accordance with the statutory form, the filing materials will be accepted and the enterprise will be issued with a record certificate for the operation of Class II medical devices.

Regulations on the Supervision and Administration of Medical Devices

Article 9. The state improves the medical device innovation system, supports the basic research and application research of medical devices, promotes the promotion and application of new medical device technologies, and provides support in scientific and technological project establishment, financing, credit, bidding and procurement, medical insurance, etc.;

Support enterprises to set up or jointly set up research and development institutions, encourage enterprises to cooperate with institutions of higher learning, scientific research institutes, medical institutions, etc. to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the ability of independent innovation of medical devices.

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Class II medical device filing process: 1. The first step: upload electronic materials online

Log in to the State Yao Product Supervision Administration** - Service - Online Service Guide - Medical Device Production and Operation License Filing - Application Enterprise - First Use Registration - After the registration is completed, fill in the application form according to the requirements - Upload electronic materials. The upload is successful, waiting for the review of the municipal bureau. 2. Step 2:

Log in to the system to check whether the municipal bureau has passed the review. After the review is passed, you can submit paper materials to the administrative service hall of the Municipal Bureau, and the Municipal Bureau window will issue the certificate on the spot.

How to handle the filing of Class II medical devices.

Hello dear, it is a pleasure to serve you <>

Class II medical device filing process: 1. The first step: upload electronic materials online

Log in to the State Yao Product Supervision Administration** - Service - Online Service Guide - Medical Device Production and Operation License Filing - Application Enterprise - First Use Registration - After the registration is completed, fill in the application form according to the requirements - Upload electronic materials. The upload is successful, waiting for the review of the municipal bureau. 2. Step 2:

Log in to the system to check whether the municipal bureau has passed the review. After the review is passed, you can submit paper materials to the administrative service hall of the Municipal Bureau, and the Municipal Bureau window will issue the certificate on the spot.

Extended information: required information: 1. A copy of the business license; 2. A copy of the SFZ certificate, academic background or professional title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality; 3. Description of organizational structure and department setting; 4. Description of business scope and business mode; 5. Geographical location map, floor plan, copy of house property right certificate or lease agreement (with house property right certificate) of business premises and warehouse address, and certificate of not being within the scope of demolition; 6. Catalogue of operating facilities and equipment; 7. Catalogue of documents such as business quality management system and working procedures; 8. Introduction to the basic situation and function description of the computer information management system; 9. Proof of authorization of the operator; 10. Reissue the loss statement of the business license; (Not required for new businesses); 11. Scanned version of the application form signed and stamped with the official seal; 12. Other supporting materials.

Do I need a practitioner to apply for a Class II medical device license?

Medical practitioners. To apply for a Class II medical device license, do you need to have a medical practitioner.

To apply for a Class II medical device license, medical practitioners are required.

To apply for a Class II medical device license, you need a medical practitioner.

Does this practitioner have to work in the company?

For the operation of Class II medical device products, the quality manager and the person in charge of the quality organization shall have a technical secondary school degree or above or a technical title of junior level or above in related majors recognized by the state and related majors (medical devices, biomedical engineering, machinery, electronics, etc.).

Or is it enough to find someone with a medical certificate?

It is enough to have a job title.

Is one enough?

No, there must be a quality manager and a person in charge of the quality organization.