Engaged in the production of Class I medical devices should be filed with the municipal people's government food and drug supervision and management department.
Definition of Class I Medical Devices:
Class I Medical Devices refers to medical devices whose safety and efficacy can be ensured through routine management. According to Article 5 of the Regulations for the Supervision and Administration of Medical Devices issued by the state, the state will implement classified management of medical devices.
The main responsibilities of the Food and Drug Administration:
Responsible for the supervision and management of the safety of drugs, medical devices and cosmetics. Formulate supervision and management policy planning, organize the drafting of draft laws and regulations, formulate departmental regulations, and supervise the implementation. Research and development to encourage the management of drugs, medical devices and cosmetics new technologies and new products and services policy.
Responsible for drugs, medical devices and cosmetics standards management. Organize the development and publication of the national pharmacopoeia and other drugs, medical equipment standards, organization and formulation of cosmetic standards, organization and formulation of classification and management system, and supervise the implementation. Participate in the development of the national essential drugs catalog, with the implementation of the national essential drugs system.
Responsible for the registration and management of drugs, medical devices and cosmetics. Formulate registration management system, strict listing review and approval, improve review and approval service facilitation measures, and organize the implementation.
Food and Drug Administration Division set up and division of labor:
I. General Division:
Responsible for the company's internal comprehensive affairs. Carry out medical device regulatory system research.
Two, supervision of a:
Organization to formulate and supervise the implementation of active medical devices, passive medical device production regulatory system and production quality management standards. Organizations to guide the production of on-site inspection, organization, investigation and handling of its production of major violations.
Third, the supervision of the Second Division:
Organization and supervision of the development and implementation of in vitro diagnostic reagents and clinical testing equipment in accordance with the responsibilities of the production regulatory system and production quality management standards. Organizations to guide the production of on-site inspection, organization and investigation of major violations of its production. Organizations to develop and guide the implementation of medical equipment business, the use of quality management standards.
Four, monitoring and testing Division:
Development of medical device adverse event monitoring management system, organization to carry out adverse event monitoring and disposal according to law. Organize quality sampling and testing, regularly issued quality bulletin. Organize and carry out medical device re-evaluation work.