1, the three meanings are different: the meaning of Class III medical devices: Class III medical devices is the highest level of medical devices, medical devices must be strictly controlled, refers to implanted in the human body, for the support, life support, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices. The meaning of Class II medical devices: Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument belongs to the second class of medical devices. The meaning of a class of medical devices: Class I medical devices refers to the routine management of medical devices sufficient to ensure their safety and effectiveness. According to the state issued the "supervision and management of medical devices regulations" the provisions of Article V, the state will be the implementation of the classification of medical devices management;
2, the three different degrees of risk: the degree of risk of Class III medical devices: Class III medical devices is a higher risk, the need to take special measures to strictly control the management. The degree of risk of Class II medical devices: Class II medical devices is a medium risk, need to be strictly controlled and managed. The degree of risk of Class I medical devices: Class I medical devices is a low degree of risk, the implementation of routine management.
Medical device business license process generally includes the following steps:
1, prepare materials: prepare the medical device business enterprise application materials, including enterprise legal person business license, tax registration certificate, organization code certificate and other documents, as well as the enterprise's basic introduction, business plan, quality management system and other related information;
2, submit the application: Will be prepared to submit the application materials to the local health administrative department or food and drug regulatory departments, submit the application and on-site audit;
3, on-site audit: the applicant needs to be on-site to accept the audit of the regulatory authorities, the auditors will be on the application materials for the item-by-item audit, and the business premises, equipment, personnel, quality management system, etc. to check;
4, Inspection and testing: medical devices submitted for application must be inspected and tested to ensure compliance with relevant national quality standards and technical requirements;
5. Qualified audit: If the audit is qualified, the regulatory authorities will issue a medical device license, the enterprise can formally operate medical devices.
In summary, the medical device license process is relatively cumbersome, the applicant needs to prepare the appropriate materials in advance, and actively cooperate with the regulatory authorities on-site audit and inspection and testing work. In the application process, the applicant also needs to comply with relevant national laws and regulations and provisions to ensure that the business activities are legal and compliant.
Legal basis:
"Chinese People's Republic of China*** and the State Medical Device Supervision and Administration Regulations" Article 20
Engaged in the production of medical devices, should have the following conditions:
(a) with the production of medical devices suitable for the production of space, environmental conditions, production equipment, and professional and technical personnel;
(b) have a quality inspection of medical devices produced (B) the production of medical devices for quality inspection organizations or full-time inspectors and inspection equipment;
(C) to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) product development, production process documentation requirements.