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2024 China NMPA Bluebook is here:
NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including some big players, BD, Boston
NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical
NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical
Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24
Are you ready for CFDA’s oversea inspection? Do you comply with Chinese Medical Device Good Manufacturing Practice? Does your current quality system meet the Chinese legal requirements? Join us for
Under CFDA Guideline Nos 14 and 218 issued in 2015, China targets sterile devices, implant and IVDs for overseas onsite inspection for registration and issuing manufacturing permit, including change order
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.
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