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 the Central Government where it is located. Among them, the “identification information (such as batch number)” column of the medical device recall event report form refers to the effective information that can clearly determine whether the product is within the scope of recall, including but not limited to product batch number, serial number, factory number, unique medical device logo, etc. When recalling medical devices that have implemented the unique medical device identification system, the unique identification information of medical devices should be indicated in the “identification information (such as batch number)” column of the medical device recall event report form (see the attached table).
Recall notification, investigation and evaluation report, recall plan and other documents, if it is necessary to clarify the scope of product recall traceability, the requirements are the same as above.