What about Class II Medical Devices

Class II medical device license conditions? (a) with a quality management license or quality management personnel, with the corresponding business license scope and scale, quality management personnel should have a nationally recognized relevant professional qualifications or titles;

(b) with a business premises in line with the scope and scale of business. Interim Measures for Technical Identification of Medical Accidents, Article 36 of the medical negligence on the consequences of the damage of medical accidents, the patient's original disease conditions and other factors to be analyzed comprehensively. Medical malpractice in the degree of responsibility for medical negligence is divided into:

(a) the full responsibility of medical malpractice, refers to the medical negligence caused entirely.

(ii) the main responsibility, refers to the medical malpractice caused by the damage is mainly due to medical negligence, other factors are secondary.

(C) secondary liability, refers to the main cause of medical malpractice is caused by other factors, medical negligence is secondary.

Second-class medical device license is easy to handle?

First, the second class of medical devices do not need to apply for a license to operate, only need to apply for the record to prove. What?

Second, what is the specific process?

(a), first of all, to the Trade and Industry Bureau for a business license, registration must be a business, it can be a corporate enterprise, unincorporated enterprises, sole proprietorships, partnerships, individual businesses and so on.

(ii), to the Quality Supervision Bureau for the agency code.

(c), and finally to the State Food and Drug Administration website to register the organization code, online reporting.

(d), "Medical Device Filing Application Form" online declaration of the required electronic materials.

Copy of the business license

legal representative, the person in charge of the enterprise, the person in charge of quality of identification, education or title certificate

organization and department description

business scope, business model description

business premises, warehouse address of the geographic location of the map, floor plan, copy of the document certifying the ownership of the house or a copy of the lease agreement (with the document certifying the ownership of the house) copy;

Business facilities and equipment directory

Documentation directory, such as the operation of quality management systems and work procedures

8. Computer information management system overview and functional description

Certificate of authorization of the operator

Scanned version of the application form signed and stamped

Third, the second class of medical devices for the record, by the municipal Food and Drug Administration for approval, the online declaration of acceptance, the enterprise is required to provide the paper materials to the The government hall to declare, after the site acceptance, issued after the record vouchers you can operate.

The second class medical device license does not require any business annual report. Log on to the national enterprise letter what with the information publicity system for the annual report of industry and commerce, is engaged in business activities of the business license what the annual report of industry and commerce, that is, the business license to engage in business activities what the annual report of industry and commerce to fill in the report. Class 2 medical devices require an administrative license, do not need to operate, and do not need to handle the annual report of industry and commerce.

How many years is the annual review of the Class 2 medical device license?

The medical device license is valid for five years. The contents of the medical device license include: license number, enterprise name, legal representative, responsible person, residence, business premises, business mode, business scope, warehouse address, licensing department, licensing date and validity period and other matters. After the expiration of the need to apply for replacement. Drug supervision and management departments as needed, should be in the "drug license license" before the expiration of the validity of the decision. Failure to make a decision after the expiration date, deemed to be granted a replacement license.