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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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