Medical device business enterprises operating medical devices in the occurrence of major quality incidents, should be reported within 24 hours of the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration.
According to the "supervision and management of medical equipment business law" Article 43 of the medical device business enterprises operating medical devices in the event of a major quality incident, should be reported within 24 hours of the location of the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration, provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall immediately report to the State Food and Drug Administration.
Expanded Information:
"Supervision and Administration of Medical Devices Law" Article 35 The medical device business enterprises entrusted to other units of the transportation of medical equipment, the carrier shall be Transportation of medical devices to assess the quality of the ability to guarantee the assessment, to clarify the quality of the transportation process of responsibility to ensure quality and safety in the transportation process.
Article 36 of the medical device business enterprises for other medical equipment production and management enterprises to provide storage, distribution services, shall sign a written agreement with the commissioning party, clear rights and obligations of both parties, and with product storage and distribution conditions and scale of equipment and facilities, with the commissioning party to carry out real-time electronic data exchange and the realization of the whole process of product management can be traced back to the computer information management platform and technical means. technical means.
Chinese government network - supervision and management of medical equipment