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On January 8th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this
On January 11, 2018, the CFDA issued a guideline for accepting medical device international clinical trial data. This new guideline could benefit foreign medical device
This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the
On October 20th, CFDA released the new technical requirements for accepting overseas clinical data for comments. This technical requirement is based on the guidelines from
On October 31st, the CFDA released and implemented the 3rd batch of “Medical Device Clinical Trial Exemption List”. There are 37 Class II, 11 Class
In accordance with the requirements of “the Decision on the Revision of the Medical Device Supervision and Management Regulations” issued by on State Council of
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
Grace Fu Palma, founder and CEO of Boston-based China Med Device (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 info@chinameddevice.com.
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
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