Medtech regulatory consultants and manufacturers are working to interpret the new medtech regulations promulgated in the People's Republic of China.
The new regulations, designed to boost supervision and administration of medical devices, will take effect October 1. They cover registration of devices and in- vitro diagnostic reagents, instructions and labels, supervision of manufacturing, and distribution. They will pick up the pace of regulation and level the playing field for domestic and imported manufacturers.
The China Food and Drug Administration (CFDA) earlier this month introduced implementing regulations that add to rules that took effect in June.The new rules emerged after years of government regulation inactivity.
Emergo Group has predicted shorter approval times for Class I devices, longer validity dates for all devices (from four to five years), more emphasis on quality management system compliance; more clinical trials and new CFDA registration fees; greater responsibility for companies’ legal agents; and a longer timeframe for in-vitro device registration.
Another Emergo report states that all device documentation must include:
Product risk analysis reports; Product technical requirements, formerly known as product registration standards; Clinical evaluations; Labeling and user manuals; Quality management system documentation; Home country premarket licenses.
Rather than a technical review for Class I devices, the CFDA will conduct a completeness check to see that all required documents have been included.
Initial regulatory reviews of Class II devices may be complete within 60 working days. Regulators plan to finish Class III registration reviews within 90 working days, unless outside expert reviews or combined device-drug reviews are necessary.
Applicants will have one year to submit information that CFDA requests. Regulators expect to review supplemental information within 60 working days, and issue licenses within 10 working days of technical reviews, the Emergo report says.
The Chinese government issued the in-vitro diagnostic reagent registration in 2007. The remaining rules had languished without an update for a decade, according to a report in Medical Device Daily.
