October 24, 2018

AstraZeneca and 5 Others Caught for Violating China’s Human Genetic Regulation: Clinical Data Rejected

The Ministry of Science and Technology of China imposed penalties today (Oct 24th) on 6 companies for violating regulations on human genetic resources. AstraZeneca and 5 domestic companies are on […]
October 16, 2018

Grace Palma to Present on ASQ and RAPS Boston

Wednesday, 24 October 2018 3:00-7:00 pm EST The Conference Center at Waltham Woods 860 Winter Street Waltham, MA 02451   Don’t miss this unique opportunity to engage with regulatory and […]
October 16, 2018

CFDA: Record Number of Guidelines and Standards Issued in September

In the month of September, unprecedented number of medical device guidelines and industry standards issued by CFDA to expedite your registration and renewal.   Guideline CFDA issued 12 Technical Review […]
October 14, 2018

Siemens, Medtronic Found Incompliance in CFDA Clinical Audit

For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report.  In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with […]
October 8, 2018

Thank You for Visiting Us at RAPS!

Thanks for taking the time to visit China Med Device at the RAPS Convergence in Vancouver.  I appreciate the opportunity to share some of the latest developments at NMPA (CFDA) […]