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“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)”

In order to fully implement the main responsibility for the quality and safety of medical device registrants, prevent and control the hidden risks of medical device entrusted production, and strengthen the supervision of medical device entrusted production, the State Food and Drug Administration organized the drafting of “Opinions on Further Strengthening the Supervision of Medical …

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Interpretation of “Administrative Measures for Medical Device Recall”

Paragraph 1 of Article 16 of the “Measures for the Administration of Medical Device Recall” stipulates that if a medical device manufacturer makes a decision to recall a medical device, it shall immediately submit a medical device recall event report form to the drug regulatory department of the province, autonomous region, or municipality directly under …

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Question and Answer for Registration of Medical Devices,IVDs

Q: What materials are included in the annex to the clinical trial report of in vitro diagnostic reagents? What are your requirements? According to the “Announcement on Publishing the Requirements for Registration Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents” (formerly China Food and Drug Administration Announcement No. 44 in …

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