China Food and Drug Administration (CFDA, formerly State Food and Drug Administration, SFDA) has been enforcing medical device regulations since 2000. With experience, the authority continues to shape the regulatory structure and recently, CFDA has been aggressively reforming its management systems, resulting in a series of regulatory updates including publishing and issuing several notices and guidance documents.
At the end of the first quarter 2014, CFDA issued an updated “Regulations on Supervision and Management to Medical Instrument” (State Council Order 650, http://www.sfda.gov.cn/WS01/CL1103/97815.html ). The new regulation was approved on February 12, 2014, by State Council, tightening controls in several areas such as the manufacturer’s responsibility for device quality, supervision of post-market surveillance and control of distribution. This regulation was enforced on June 1, 2014. In the interim, CFDA released a draft version of measures associated with the new regulation for public comment (http://www.sda.gov.cn/WS01/CL0779/97818.html). Included measures covered medical device registration, IVD registration, labeling, and Class II and Class III Clinical trial exemption list. The drafted measures brought significant changes compared to current rules. However by June 1, only the regulation itself was enforced, and these measures have yet to be finalized. (http://www.sfda.gov.cn/WS01/CL1103/100660.html).
On August 1, 2014, five measures associated with the regulation were finalized, and the enforcement date was set for October 1, 2014. The finalized measures incorporated fewer changes than the drafted version. (http://www.sfda.gov.cn/WS01/CL1103/103755.html). They are:
CFDA also released notices or guidelines to clarify the applicability of the current measure during the transition period. .
In response to these significant changes with rush transition period, UL technical experts provide the following insights for manufacturers to consider regarding the new measures.
Drafting the product’s technical requirements, compiling dossier, and arranging the submission document plays a crucial role in the success of the entire registration process. The extended registration duration and overall complicated process made these tasks vulnerable. A qualified agent can reduce the learning curve and increase the chances of success.
Based on UL’s experience, software documentation, risk management and clinical evaluation are three main documents that reviewers easily criticize. Prior to official submission, ensure these documents comply with the guidance published by CFDA.
Although it is mandatory to conduct the registration testing in a CFDA designated testing lab, you can still find a good testing consultant with experience to anticipate more about how the testing is performed in order to implement the preventive action if necessary. Re-test or design modifications are a common cause of registration delay.
CFDA has published the exemption list of Class II and Class III devices. A qualified clinical evaluation report is considered crucial while registration. CFDA releases drafted version of “Principle of medical device clinical evaluation” for public comments on late August. We recommend that manufacturers consider this drafted version as a direction of CFDA’s current thinking.
The new regulation requires stronger control of the manufacturer’s quality system along with its associated supply chain. Despite the fact that a CFDA on-site audit has historically been uncommon, it is possible that CFDA will increase the frequency or be more willing to conduct more frequent on-site audits. In addition to the manufacturer, the legal agent in China should also be aware of the requirements from new measures.
Based on the 2014 regulation, the strengthening of supervision and tightening of control are foreseeable trends. The new regulation also indicates that CFDA is able to charge applicants a review fee, which had been free of charge. Therefore CFDA may have a larger budget to implement and execute these measures. In order to mitigate the risks of registration testing and make the CFDA registration process more smooth, prior to submission, manufacturers should become familiar with the new regulations.