Article 32 of the State Administration of Quality Supervision to establish the risk of imported medical devices early warning mechanism. Through the collection and assessment of defective imported medical devices and other information, in accordance with relevant regulations issued warning information, and take appropriate risk warning measures and rapid response measures.
Article 33 The inspection and quarantine agencies need to regularly understand the jurisdiction of the quality of imported medical devices used, found that the import of medical devices in the event of a major quality incident, should be promptly reported to the AQSIQ.
Article 34 of the manufacturers of imported medical devices, imported units and the use of units in the discovery of defects in their medical devices should be reported to the inspection and quarantine institutions, inspection and quarantine agencies to take risk warning measures and rapid response measures should be coordinated.
Article 35 of the defective imported medical devices risk warning measures include:
(a) to the inspection and quarantine agencies to issue risk warning notification to strengthen the defective products produced by the manufacturer and importer of imported medical devices imported inspection and supervision;
(b) to the manufacturer of defective products, imported units to issue a risk warning notices urging timely measures to eliminate risks;
(c) to the manufacturer of defective products, imported units issued risk warning notices to urge them to take measures to eliminate risks.
(c) to consumers and users of risk warning notices to remind them of the risks and hazards of defective imported medical devices;
(d) to the relevant domestic departments, the relevant countries and regions in China, embassies or liaison offices, the relevant international organizations and institutions to inform the situation, and recommend that they take the necessary measures.
Article 36 of the defective imported medical devices of rapid response measures include:
(a) recommended to suspend the use of defective medical devices;
(b) adjust the defective imported medical devices imported units of the classification and management of the category;
(c) to stop the defective medical device imports;
(d) suspend or revoke the defective Imported medical devices of the national mandatory product certification;
(e) other necessary measures.