RAMED Kick-off Activity in the United States

RAMED Biosciences held 1st CFDA Regulatory Affairs Forum in Minneapolis, Minnesota, USA

RAMED Biosciences and the Minnesota Chinese Association for Science and Technology (MCAST) jointly held the “2017 China Regulatory Affairs Forum for Medical Devices” on December 2, 2017, at the Humphrey Conference Center in Minneapolis, Minnesota, sharing with guests the impacts and challenges of CFDA’s new requirements for global medical device companies in China. Speakers Yongheng Chang, Ellen Jiang, and Julia Niu introduced topics including: CFDA Organization and Function Update; CFDA Medical Device and IVD Regulation Evolution; CFDA Regulatory Compliance and Practice; and Medical Software CFDA Registration Introduction. The event drew attendees from Medtronic, Abbott Laboratories, 3M, Boston Scientific, and several medical device startups. The keynote speaker, Mr. Chang Yongheng, is the Executive Chairman of the China International Medical Device Regulatory Forum (CIMDR) of the CCFDIE of CFDA. He has led the China International Medical Device Regulation Forum since 2010.

RAMED Biosciences held Regulatory Affairs Forum in Boston, Massachusetts

RAMED Biosciences held the “2017 China Regulatory Affairs Forum for Medical Devices” on December 8, 2017, at the Cambridge Innovation Center, Cambridge, MA. The forum covered several topics, including: CFDA Organization and Function Update; CFDA Medical Device and IVD Regulation Evolution; CFDA Regulatory Compliance and Practice; and Medical Software CFDA Registration Introduction. Attendees included the founders of medical device and life-sciences startup companies; investment companies; and regulatory affairs professionals from the Greater Boston Area. Event speakers Yongheng Chang, Ellen Jiang, and Julia Niu discussed compliance issues and the impacts and challenges of CFDA’s new requirements for global medical companies. Boston is at the core of the global life-science and pharmaceutical industries. The city has gathered not only world-renowned biopharmaceutical and life-science companies, but also has attracted numerous biotechnology innovation companies.

RAMED attended 2017 CABA MDDI Symposium as Speaker

Ellen Jiang presented “China CFDA In Vitro Diagnostics (IVD) Approval Process” at the 2017 CABA Medical Device and Diagnostics Innovation Symposium (MDDI) on December 9, 2017. CABA (Chinese-American BioMedical Association) is a not-for-profit professional organization in Massachusetts. Since May of 2007, CABA has been committed to promoting public awareness of advancement in the pharmaceutical and biomedical industry, and professional interactions in the fields of life-sciences, global biomedical innovations, and business development. Approximately 150 guests attended the 8th annual Innovation Symposium. Speakers included the president of Thermo Fisher-Michael Shafer, President of Vascular Sciences-Michael Drues, and CEO’s from various startup companies. They covered diverse topics from “The Democratization of Cryo-Electron Microscopy” to “Trends and Investment Considerations for the Future of 3D Printing in Healthcare” to “Connected Health for Tomorrow -- Wearable Sensors for Vital Signs Monitoring,” among others. CFDA reviewers attended the symposium and shared two topics, including “Study of the Guiding Principles for the Registration of Custom Medical Device in China” and “From 3D Printing to Custom Medical Device -- Considerations for the Technical Review.” Ellen’s speech received a warm welcome from the guests, and CABA sent a special email to Ellen to thank her for her contribution in the symposium.