NMPA Reminder: New Requirements for Medical Device Recall Reporting

On April 11, NMPA issues an interpretation of the Administrative Measures for Medical Device Recalls.

The content of the announcement specifically emphasizes: 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 to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where it is located. Among them, the “identification information (such as batch number)” column of the medical device recall event report refers to the effective information that can clearly determine whether the product belongs to the recall scope, including but not limited to product batch number, serial number, factory number, unique identification of medical device, etc.If the recall notice, investigation and evaluation report, recall plan and other documents need to clarify the scope of product recall traceability, the requirements are the same as above.

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