A. About the one-year validity period of the registration test report of medical device clinical trials Article 7 of the “Medical device clinical trial quality management practices” provides: “quality inspection […]
Grace Fu Palma, founder and CEO of Boston-based China Med Device (http://www.ChinaMedDevice.com), a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers new updates on CFDA clinical trial reform in China by CFDA. China Med Device specializing in providing turn-key solution for medtech companies, brings you up to date information on CFDA. If you have any feedback, please e-mail to firstname.lastname@example.org.
On May 11, 2017, the State Food and Drug Administration issued a notice (Opinion No. 53 of 2017) on the "Policy on Encouraging the Reform of Clinical Trials of Drugs and Devices Innovations" (draft). The "draft" is to further deepen the review and approval system reform, promote the pharmaceutical and medical device industries restructuring and technological innovation, improve industrial competitiveness, and to meet the public needs.
1. Accreditation approval to letter to file: the clinical trial institution qualification approval has been changed from the original accreditation process by CFDA to a simple letter to file at the designated registration website. The reform intends to encourage social capital investment to set up clinical trial institutions and to provide clinical trial professional services. The main investigators should have a senior title and have participated in more than three clinical trials. Clinical trial Applicants may employ a third party to evaluate the accreditation of the clinical trial institution. The supervision and validation will be shifted on-site inspection by CFDA officials. The inspection results will be announced to the public. Failure to pass the examination of the clinical trial project, the relevant data will be rejected by CFDA.
China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA […]