Full Life Circle Management for the New Medical Devices

May 11th 2017, CFDA issued a policy ‘About Encourage Medicines and Medical Devices Revolution, Establish the New Medical and Medical Devices Full Life Circle Management Regulations (first draft)’. CFDA encourages publics to make suggestions before May 25th 2017 through Email (yhzcszhc@cfda.gov.cn). International companies can also contact us by elaine@cirs-group.com or phone number：57187206559 for more information. The deadline is June 10th 2017.
Main Content:
1. The applicants have the responsibility for the medical devices going to the market.
2. Improve the medical device adverse reaction reporting system.

Establish the applicants’ medical device adverse reaction reporting system. After the products going to the market, applicants should still keep eye on the medical device research and risk evaluation. Report the adverse reaction and be responsible for the adverse reaction. And applicants must give medical device remediation action. If any the adverse reaction happened, the applicants do not report or delay the report. Audit committee will punish without mercy.

3. Upgrade the reevaluation system for the medical devices

If the safety and efficiency of the medical devices changed as the development, the applicants need to do the self-evaluation of their products.

Any changes of the medical devices need to report to the original register community. CFDA will reevaluate the products and give the permission if these medical devices can be resold in the market.

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