On March 13, 2014, the China Food and Drug Administration (CFDA) announced the Five Rectifications Campaign, a special five-month enforcement campaign targeting medical devices. The Campaign will focus on medical device registration, manufacturing, distribution, advertising, and use in healthcare institutions. The campaign began on March 15, 2014 and will end on August 15, 2014.
False Information in Registration Applications
The Campaign against false registration information will focus only on Class II and Class III medical devices. In China, Class II and Class III devices are considered higher-risk and, under most circumstances, require clinical trials prior to obtaining approval for marketing. The Campaign specifically targets false clinical trial reports and fake sample products submitted for testing during the registration process.
The Campaign against manufacturing violations will concentrate primarily on a few specific types of medical devices and certain problematic manufacturing practices. One area of focus will be the use of raw and semi-finished materials that do not meet relevant standards to manufacture disposable infusion/injection instruments and disposable catheters, as well as the improper sterilization of those devices. A second area will be unauthorized contract manufacturing of condoms. The last area will be the release of hemodialysis concentrate that does not meet relevant standards.
The Campaign against illegal distribution will be focused narrowly on only certain distribution practices. CFDA will scrutinize distribution of unregistered Class II and III devices via experiential marketing (i.e., by supplying user samples). A second area of focus will be the distribution of unregistered colored contact lenses and hearing aids. The last area will be on the distribution of in vitro diagnostic reagents that have not been stored or transported in accordance with relevant standards and regulations.
Exaggerated Advertising Claims
The Campaign against advertising will focus on exaggerated therapeutic claims for products for back or leg pain, nearsightedness, diabetes, hypertension, and physiotherapeutic products; exaggerated product indications and efficacy claims in unapproved advertisements (under the new Medical Device Regulations, all advertisement must be based on the approved labeling, be true, and not contain false, exaggerated, or misleading content); and illegal endorsements by research organizations, technical experts, and patients.
Use of Unregistered Devices
The last piece is the Campaign against the use of unregistered in vitro diagnostic reagents by medical institutions. This focus accords with CFDA’s increased scrutiny of unlicensed human genome-sequencing instruments, reagents, and related software and their use by medical institutions.
During this special period of enforcement, violations found within the scope of the Campaign will be punished by the maximum penalty allowed by law. These maximum penalties are set to increase when the new Medical Device Regulations come into effect on June 1, 2014. In addition, for serious violations, CFDA may revoke medical device registrations and licenses to operate, including medical device manufacturing and distribution licenses. CFDA may also order recalls of unsafe devices and refer any suspected criminal cases to the public security bureau for criminal investigation and prosecution.