CFDA: New Provision for the Recall of Medical Devices Published8. March 2017
The latest revised regulations for the supervision and administration of medical devices was implemented on June 1, 2014 and includes requirements for the recall of medical devices. The China Food and Drug Administration (CFDA) organized the revision of the provision for the recall of medical devices. The provisions for the recall of medical devices (CFDA No. 29) were adopted at the CFDA executive meeting on January 5, 2017 and will be effective as of May 1, 2017.
Medical products need a CFDA registration in China.
The following products must be recalled according to the new provision:
1) Products that present undue risks that could endanger human health and safety during normal use
2) Products which do not comply with the prescribed standards and technical requirements
3) Products which are not produced according to the production and quality standards.
The manufacturer is responsible for ensuring that only products conforming to relevant Chinese quality standards are marketed within China. The manufacturer is also responsible for a recall, if necessary, for products that are defective or fall within the above stated regulation regarding recall. If a manufacturer of medical devices fails to remove non-compliant products from the market within a reasonable period of time, the manufacturer will bear the full responsibility and will likely face steep fines, and/or penalties.
There are three different types of recalls, which are classified according to the severity of the deficiencies. A severe deficiency is present if the use of the medical device can result in serious health damage. In case of serious defects, the recall must be announced within one day. A median deficiency is referred to when the medical device could cause temporary or reversible health damage. In the case of medium deficiencies, the recall must be notified within three days. A slight deficiency is given if the use of the medical device could possibly cause minor health damage. In the case of slight defects, the recall must be notified within seven days.
The recall of a medical device is a very complex process because it has to be done at different levels of authority. Furthermore, not only the manufacturer, but also the “legal agent” as well as the user of the medical device is involved in the process. Therefore, the support of a competent consultancy can make the process much easier.
The purpose for these changes is to promote further improvement of China’s medical device standards system, and build a solid foundation for ensuring the safety and effectiveness of medical devices. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future. In our “News” section on our website, we will keep you informed about official announcements and changes to the regulations.
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