Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 35 of the medical device registrant, the filer, the commissioned manufacturer shall, in accordance with the quality management standard for the production of medical devices, to establish and improve the production of medical devices and to ensure that the quality of management system and ensure its effective operation; in strict accordance with the registered or filed by the technical requirements of the product organization Production, to ensure that the factory medical devices in line with mandatory standards and registered or filed product technical requirements.
Medical device registrants, filers, commissioned manufacturers should be regularly on the operation of the quality management system for self-examination, and in accordance with the provisions of the State Council drug supervision and management department to submit a self-examination report.
Article 36 of the medical device production conditions change, no longer meet the requirements of the quality management system for medical devices, medical device registrants, filers, commissioned manufacturers shall immediately take corrective measures; may affect the safety and efficacy of the medical device, shall immediately stop production activities, and to the original production license or production filing department report.
Article 37 of the medical device shall use the common name. Generic name should be consistent with the State Council drug supervision and management department to develop medical device naming rules.
Article 38 of the State according to the medical device product categories, the step-by-step implementation of the unique identification system for medical devices, medical devices to achieve traceability, the specific measures developed by the State Council drug supervision and management department in conjunction with the relevant departments of the State Council.