China’s FDA Issues Regulation on Quality Supervision

January 8, 2016

Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation.

The regulation, which takes effect Feb. 1, 2016, includes reminders to follow the rules, such as procurement needs to go through proper channels and only use CFDA-approved devices, says Helen Chen, head of L.E.K. Consulting’s China life sciences practice.

“There are explicit statements that the Western audience would consider standard, such as the expectation that equipment should be properly maintained. That the CFDA would actually need to outline these steps explicitly is a sign that they recognize the variability within the Chinese hospital system, and that they want to get to a reasonably uniform standard around medical technologies management,” she said.

Device and Diagnostic Registration

Chinese health regulators also are encouraging hospitals to leverage information technology for document retention tracking, ranging from five years after the service of an instrument to indefinite maintenance of the initial intake inspection records for implants, says Chen. Building hospital information technology infrastructure is one of the initiatives introduced as part of the 12th Five-Year Plan in 2011.

The CFDA makes it clear that it is serious about the violations, setting fines of up to $3,150.

In addition, the regulator issued a notice on interprovincial corporate registration, giving examples of what happens when companies are setting up, transferring or shutting down operations between two provinces. The information is geared towards domestic companies, Chen says.

The CFDA also issued a notice on implementing registration management practices for devices and in vitro diagnostic reagents. The document, released in response to questions about standards that took effect Oct. 1, 2014, clarifies topics such as biological testing, says Jack Wong, director of regulatory affairs for Asia Pacific in TerumoBCT’s Singapore branch.

The agency also posted a document interpreting the medical device regulation to address confusion expressed by applicants regarding the registration process, such as which kind of changes are necessary to apply for modified registration and what are the requirements for notarization, Wong said.

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