China Ramps Up Device Inspections, Fast-Track Approvals

China’s Food and Drug Administration boosted device approvals by 20 percent in 2016.

Overall, the agency approved 5,751 device applications, according to CFDA’s annual progress report for 2016. Eight applications were rejected for data integrity issues.

CFDA conducted more than 30 overseas inspections in 2016 and plans to inspect 30 to 40 foreign companies every year for the next five years.

The authority accepted 1,690 applications for Class II imported devices and 1,405 applications for imported Class II in vitro diagnostic devices, according to the agency’s 2016 report. It accepted 2,331 applications for imported Class III devices and 487 imported IVD Class III applications.

The agency has revised its review process, so all imported devices will be reviewed by CFDA, as well as Class III domestic products. Class I and II devices from domestic manufacturers will be reviewed by provincial FDAs.

CFDA’s device review process is faster than that of the U.S., Dan Zhang, CEO of Beijing-based CRO Fountain Medical Development, told IDDM. In 2016, the CFDA approved 45 innovative devices via its fast-track pathway. Similar to the U.S. FDA’s breakthrough pathway, the innovative pathway can shorten development time by 18 months.

Katherine Wang, Shanghai-based partner in the law firm Ropes & Gray, said the assessment of risk by China’s regulators is usually more conservative than that of the U.S. FDA. For example, a product that is qualified for the 510(k) application pathway in the U.S. would be considered a Class III product in China.

There are significant delays in updating Chinese standards to reflect the latest ISO standards, so device makers seeking to introduce new technology to the Chinese market need to be sure the product complies with the Chinese standards.

“This requires companies to really think about the Chinese standards and its complications during the product development stage,” she said.