Almost 12 months ago, the China Food and Drug Administration (CFDA) has begun reviewing the eight-year-old rule on adverse event monitoring. The text from 2015 searched for opinions on the suggested inclusion of a classification for serious hostile events, together with the governing reporting requirements and timelines for occurrences that linked into the category.
Likewise, the draft was used by the CFDA to measure the responses of the industry to plans to subject devices related frequently to adverse events to stricter monitoring.
This week, the text that was released keeps the previously inserted of severe adverse events and many of its effects for the manufacturers of medical devices. The said manufacturers are expected by the CFDA to begin the investigation of the suspected grave adverse events immediately and to report the instance to the local monitoring technology agency within 15 days. However, the adverse event reporting time falls to five days if a patient has died. The said timelines are unchanged from the 2015 draft.
As to the compliance of manufacturers, CFDA kept the same penalties for failure to comply the reporting requirements. So as to the manufacturers who will be charged with poor monitoring and reporting practices or deliberately concealing an adverse event, they will be construed to pay fines between RMB 5,000 and RMB 20,000 ($738 to $2953). The text also provides powers to the officials to impose RMB 20,000 fines on businesses that lack personnel who are responsible for adverse event monitoring or have failed to create a structure in handling the task.
Irrespective to the unchanged guidance from its initial draft, the CFDA has also revised the order, wording and intent of the latest version of the text in multiple areas. This latest draft toughens the activities manufacturers should practice especially when certain safety situations ascend.
Now, compared from the previous text, CFDA already demands the manufacturers to immediately end the manufacture and sale of medical devices in certain conditions. As to the workers, the new draft from CFDA also paves way for the compensation payments.
Until the end of November, CFDA will be accepting comments regarding the latest released text for manufacturers of medical devices.
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