By Nick Otto
The China Food and Drug Administration (CFDA) last month released revisions (in Chinese) to administrative measures that, on Oct. 1, will affect the way medical devices are registered in the country.
According to the new registration requirements, all Class II and Class III devices must undergo clinical testing unless they meet the following criteria:
- The clinical application of a similar device has been listed for a period of time with no serious adverse events — the CFDA, however, does not specify what that time period is.
- The safety and effectiveness of the device can be proven by a nonclinical evaluation.
- An analysis and evaluation can be obtained on similar clinical data or clinical trials to prove safety and effectiveness.
Once a clinical trial application is submitted, the CFDA will have 40 days to review it and another 20 days to approve or disapprove the trial.
The order also details new requirements for device registrations in the country.
According to the Emergo Group, Class I device makers will need to submit “filings rather than registrations” to the agency, which Emergo says could mean shorter approval times for industry.
Filing documents for the Class 1 devices require clinical evaluations, labeling and user manuals, and home-country premarket licenses, among other documents.
Once submitted, Emergo says Chinese officials will evaluate the application for completion, rather than as a technical review.
Although the same documentation will be required for Class II and Class III device registrations, the order says Chinese regulators will plan to complete an initial review of Class II registrations within 60 working days and for Class III registrations within 90 working days.
The order notes registrations will be valid for five years.