Article 38 The medical device manufacturer shall, in accordance with the requirements of the quality management standard for the production of medical devices, the establishment of a quality management system and maintain effective operation.
Article 39 The medical device manufacturer shall carry out medical device laws, regulations, rules, standards and other knowledge training, and establish training files. Production position operators should have the appropriate theoretical knowledge and practical skills.
Article 40 of the medical device manufacturer shall be registered or filed in accordance with the technical requirements of the product production organization, to ensure that the factory medical devices in line with mandatory standards and registered or filed by the technical requirements of the product. The medical device shall be qualified by the inspection and accompanied by qualified documents.
Article 41 The medical device manufacturer shall regularly in accordance with the requirements of the quality management standard for the production of medical devices quality management system for the operation of a comprehensive self-inspection, and at the end of each year to the location of the provinces, autonomous regions, municipalities directly under the Central Government or municipal food and drug supervision and management departments to submit an annual self-inspection report.
Article 42 of the medical device manufacturers of production conditions change, no longer meet the requirements of the quality management system for medical devices, medical device manufacturers shall immediately take corrective measures; may affect the safety and effectiveness of medical devices, shall immediately stop production activities, and to the county-level food and drug supervision and management department report.
Article 43 of the medical device products have been discontinued for more than one year and no similar products in production, production, medical device manufacturers shall report in advance in writing to the location of the province, autonomous region, municipality directly under the central government or municipal food and drug supervision and management department, after verification of compliance with the requirements before resuming production.
Article 44 of the medical device manufacturer does not have the original production license conditions or with the record information does not match, and can not be contacted, by the original licensing or filing department publicity, according to law, the cancellation of its "Medical Device Manufacturing License" or in the first class of medical devices production record information to be marked and announced to the community.
Article 45 The medical device manufacturer shall produce in the licensed or filed production site, the production equipment, process equipment and testing instruments and other facilities and equipment to maintain and ensure their normal operation.
Article 46 The medical device manufacturer shall strengthen the procurement management, establish a supplier audit system, supplier evaluation, to ensure that the procurement of products meet the statutory requirements.
Article 47 The medical device manufacturer shall record the procurement of raw materials, production, inspection and other processes. Records should be true, accurate and complete, and meet the requirements of traceability.
Article 48 The state encourages medical device manufacturers to use advanced technology to establish information management system.
Article 49 The medical device manufacturer produces medical devices in the event of a major quality incident, shall report within 24 hours of the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration, the province, autonomous region, municipality directly under the Central Food and Drug Administration shall immediately report to the State Food and Drug Administration.