Chinese guidebook for medical device adverse

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Chinese guidebook for medical device adverse

The proposed Measures contain the requirements for reporting, evaluating, and remediating adverse events and serious adverse events for both imported and domestically manufactured devices in China.

The comment period closed on December 20th. We describe some of the key points of the proposed Measures below. The proposed Measures are a revision of a rule of the same name. The proposed Measures contain a number of changes to the medical device adverse event reporting system, including the addition of a new definition of serious adverse event SAEa system of enhanced monitoring for certain devices, and a set of detailed requirements and timelines for government agencies, manufacturers, distributors, and healthcare institutions to monitor, report on, and analyze adverse events.

CFDA committed to expand these institutions in see our earlier entry, here. The proposed Measures set forth five circumstances in which an adverse event would constitute an SAE: The proposed Measures have more detailed reporting requirements than the rule.

Individuals may also report suspected adverse events. The manufacturer or healthcare institution must report the event within 15 days of its occurrence or of learning of its occurrence. If the SAE causes death, a report must be submitted within five days. For normal adverse events, the report must be submitted within 30 days.

In addition, both Chinese domestic medical device manufacturers that distribute their devices outside of China and foreign device manufacturers must report SAEs that occur abroad. Foreign manufacturers must make those reports within 15 days of the event or of knowledge of the event.

Once reported, monitoring institutions at different levels of government provincial and municipal will evaluate those events and report to the provincial food and drug regulatory agency for Class I and Class II devices or the CFDA for Class III and imported devices.

If CFDA or the provincial food and drug authorities determine that additional steps are necessary to control the event, then they will communicate that decision to local healthcare regulatory authorities. Devices with frequent or more severe adverse events may be subject to enhanced monitoring.

In that case, provincial monitoring institutions must monitor the device according to a special plan determined by the provincial food and drug authorities. Devices with problematic records may also require re-evaluation.

Noteworthy

Specifically, if reported adverse events raise questions about the safety or the effectiveness of the device, either the manufacturer or the provincial food and drug regulatory authorities can re-evaluate the device to determine necessary measures need to be taken to control those issues.

If the event is determined to be the result of a medical accident, healthcare authorities must take steps to resolve the problem, although the proposed Measures do not include detail as to that process.

Chinese guidebook for medical device adverse

The proposed Measures impose penalties for failing to properly monitor or report adverse events, such as fines or, in more extreme cases, orders to stop production or cancel licenses. The proposed Measures also state, however, that the content of adverse event reports and related risk analyses may not serve as the basis for disputes or litigation surrounding medical treatment or for resolving incidents related to medical device quality.

All device manufacturers that distribute their devices in China should continue to monitor the progress of this rule, and its implementation.Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations () market research report available in US $ only at schwenkreis.com - Buy Now or Ask an Expert To know More about this report.

Chinese Guidebook for Medical Device Adverse Event Reporting and Monitoring is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device adverse event reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical.

However, when searching on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall and adverse event reports for those that made by overseas and multinational medical device manufacturers.

If the SAE causes death, a report must be submitted within five days. For normal adverse events, the report must be submitted within 30 days. In addition, both Chinese domestic medical device manufacturers that distribute their devices outside of China and foreign device manufacturers must report SAEs that occur abroad.

Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device adverse event reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical.

Access China Report Copy right © Access China Management Consulting Ltd. 1 Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations.

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