Class I: No medical device license is required.

The first type of medical equipment is low risk and can be guaranteed to be safe and effective through routine management, such as scalpels, surgical scissors, manual sickbeds, medical ice packs, cooling stickers and so on. Its products and production activities are managed by the municipal food and drug supervision department with districts. All business activities are liberalized without permission or filing, and only the business license issued by the industrial and commercial department is required.

Category II: The US Food and Drug Administration is responsible for the management of medical devices.

The second kind of medical devices are medical devices with moderate risk and need strict control and management to ensure their safety and effectiveness, such as band-AIDS, condoms, thermometers, sphygmomanometers, oxygen generators, atomizers and so on. Its products and production activities are managed by the provincial food and drug supervision department, and the Medical Device Registration Certificate and the Medical Device Production License are issued respectively. Business activities shall be filed by the municipal food and drug supervision department with districts.

Requirements for Class II medical devices

1, with a storage area of 45 square meters, including office area 15 square meters.

2. 1 Medical professionals are responsible persons of the enterprise.

3, product management directory

Note: If the above three points are met, the filing of Class II medical devices can basically be handled.

Category III: The State Administration of Medical Products handles medical device licenses.

Three types of medical devices refer to medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. Therefore, the state's control over this piece is very strict. Therefore, for Class I and Class II, because of the low risk, only an ordinary company is needed, and Class II has moderate risk, and it is also necessary to make a record.

The third kind of medical devices are those with high risk and need to be strictly controlled and managed by special measures to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous indwelling needles, heart stents, ventilators, CT, magnetic resonance imaging and so on. Its products and production and business activities are managed by the State Administration, provincial food and drug supervision departments and municipal food and drug supervision departments with districts, and medical device registration certificates and medical devices are issued respectively.

Licensing requirements for three types of medical devices:

1. Address requirements: generally, the office area shall not be less than 100 square meter, and the warehouse area shall not be less than 60 square meters;

2. Disposable sterility: the office area is not less than 60 square meters, and the warehouse area is not less than 80 square meters;

3. In vitro diagnostic reagents: the office area is not less than 60 square meters, the warehouse area is not less than 100 square meters, and the refrigerating room area is not less than 40 cubic meters.

4. Personnel requirements: 3 people with bachelor degree in related medical industry.

Matters needing attention in handling three types of medical device licenses:

1. The office address is commercial, and the area is subject to the building area on the property ownership certificate;

2, in vitro diagnostic reagents must have a cold room, and 40 cubic meters, medical freezer useless, must be a cold room; Because it involves the follow-up teacher's on-site investigation;

3. The third-class personnel must be in the undergraduate medical industry, and then apply for the third-class medical device license. The teacher there has an interview, so this person is very important and cannot be affiliated. The annual inspection also involves these three types of people, so the most important thing to apply for the third-class medical device license is the personnel. Our Xunling enterprise service has no address, but the staff can't provide it.

4. The registered address in the company's business license should be consistent with the actual office address. If the address on the business license is the park address, it needs to be moved to the actual office address or the address provided by us, because not every park address can increase the business scope of the related three types of medical devices, and without this business scope, it is impossible to apply for the three types of medical device licenses;

5 sales of three types of medical devices must have a registration certificate. With this certificate, we can be sure that the three types of medical devices are qualified and formal. Then, apply for three types of medical device licenses and submit materials. This product registration certificate is one of the most important materials.

How to write a description of filling in social security labor records?

There is no compulsory filing of labor contracts, and there is no clear law. However, the Labor Relations Department of the Human Resources and Social Security Bureau in most areas requires that the labor contract be filed within 30 days. If it is not filed in time, it can be filed again. The employing unit shall issue a statement that it has not been filed in time, and affix its seal to the employment filing management department.

According to Article 4 of the 2006 Notice on Establishing the Recording System of Labor and Employment:

Where an employer recruits a new employee or renews a labor contract with an employee, it shall conduct employment filing within 30 days from the date of recruiting or renewing the labor contract. If the employer and the employee dissolve or terminate the labor contract, they shall file employment records within 7 days after the dissolution or termination of the labor contract.

How to write the social security filing instructions?

I. The contents of the social security statement are as follows:

1, first state the name and ID number of the social security person.

2, which unit belongs to, the unit belongs to the situation (business or enterprise).

3. Write down the date and reason for paying social security.

I promise that if the above information is true, I will bear the adverse consequences caused by providing false information.

5. Name and date of the company. (detailed to year, month and day).

6. Signature of the social security person and signature and seal of the person in charge of the unit (seal of the unit). Two, the description of social security is generally the social security payment certificate and the qualification certification required by the employer or individual when participating in social security and paying insurance premiums.

Template of commitment letter for medical treatment in different places?

The template of commitment letter for medical treatment in different places is as follows

Personal commitment letter

I (ID number:) handle business. If I can't provide proof for personal reasons, I guarantee that I meet the requirements for handling this business, and the information is true, accurate, complete and effective, and all legal responsibilities arising therefrom shall be borne by me.

Contact telephone number:

Mailing address:

Organizer (signature, fingerprint):

Date, year and month

Description of approval of parking registration certificate?

Application for the opening of parking lot operators;

2. A copy of the industrial and commercial business license provided by the industrial and commercial department or a notice of approval of the enterprise name;

3, the planning department of the construction project planning acceptance certificate;

4. Effective credit certificate, economic guarantee or parking insurance contract;

5. Site plan;