EMERGO SUMMARY OF KEY POINTS:

• Chinese medical device regulators have addressed frequently asked questions about clinical trial timeframes and filing requirements.
• The CFDA appears to have stepped up actions and clarifications regarding clinical trial requirements and policies in recent months.

China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices.

According to Emergo consultants in Hong Kong, the CFDA has identified two common questions (link in Chinese) regarding clinical trial timeframes and filing processes.

• First, a clinical trial must be initiated within one year after a registration test report is issued. In cases where trial sponsors are conducting multi-center studies, the initiation date refers to the time when a protocol passes an ethics review at the main clinical trial site. For other clinical trials, the initiation date is the time when the protocol passes ethics review at each study site.
• Second, regarding filing clinical trials at local or provincial CFDA offices, applicants may submit separate filings after signing contracts with each trial site and then initiate their trials immediately; applicants do not have to wait until contracts have been signed at all trial sites. Also, when trial sponsors are submitting clinical trial filings multiple times, they should submit all previous filing forms pertaining to the same trial, as well.

Other recent Chinese regulatory actions regarding medical device clinical trials reported by Emergo include the launch of a new clinical trial inspection program as well as a new round of clinical trial exemptions for some Class II and Class III devices.

Related Chinese medical device regulatory resources:

• CFDA medical device registration support
• CFDA Agent in-country representation for foreign companies
• Medical device clinical trial study design and protocol development support