Reporting of adverse reactions of medicament or medical devices provides valuable information for TFDA, manufacturers, medical professionals and customers in identifying the potential risk of a certain treatment. As technology develops, general report systems for the whole pharmacy field is no longer adequate. Therefore, to deliver a more practical and effective safety surveillance specifically for medical devices, TFDA is planning to launch a new reporting system for reporting serious adverse events related to medical devices.
Below lists- out the major differences of the current and future regulation:
- 1. While reporting, medical device distributor or medical institutes should list out the following items:
(i) Name, address, contact info of the reporting firm or institute
(ii) Date of occurrence and acknowledgement of the adverse event
(iii) The Chinese name, certificate number or registration code of the medical device
(iv) The type, model, and lot of the medical device
(v) The source of supply and the flow of the device. If the reporter is the end-user, the traceability of the device is not needed.
(vi) The current situation of the reported device
(vii) The category and the result of the adverse event
(viii) The description of the adverse event
- 2. After reporting, the holder or the register of the medical device certificate should investigate, evaluate, take corrective and preventive actions actively.
- 3. All documents related to the adverse event should be kept for at least 5 years. If the certificate is transferred within this period, the transferee should continue to keep the records.
- 4. While being requested to provide patient or medical device related information and document, medical device institute or distributor should not avoid, hinder or refuse.
- The major differences in the current and upcoming “Reporting Form for Serious Adverse Events of Medical Devices” are the following:
- (i) UDI and GMDN code of the medical device should be provided.
- (ii) Item added: “Is the product a single-use medical device being re-sterilized?”
- (iii) Item added: “The source of the supplement of the medical device?”
- (iv) Item added: “Have you contacted the distributor/manufacturer?”
- (v) IMDRF terminologies for categorized adverse event reporting should be provided
- (vi) The institute where the adverse event occurred and handled should be provided.
- (vii) The Investigation of the whole adverse event should be recorded.
Reference: TFDA Notice: Drafting of “Regulations for Reporting Serious Adverse Events of Medical Devices”