Very well stated Paul. Personally, I remember navigating those grey waters with you: I was in Singapore, and you were Head of the Notified Body. We laugh now at what we remember, because we weren't always correct. But, we were always aligned, and that was important. I remind people that today's changing regulatory environment is not ...

Kevin, Thanks for sharing the flow chart , provides clarity to the process. Thanks, ...................................................... Rashmi Pillay Regulatory Affairs Manager T +61 8 7074 8105 E rpillay@ellex.com ------Original Message------ Attached ...

It is not clear if you are discussing an in vitro diagnostic device. If you are, FDA has recognized CLSI standard EP25-A on Stability Testing of Diagnostic Reagents for instructions on how to perform this testing.  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30533. Real time stability testing ...

Hi all,  After the Mutual Recognition Agreement, EMA does not inspect US establishments.  I have a question on how to obtain a cGMP declaration from FDA for an establishment manufacturing a biologics (whose submission would go through CBER).  I am aware of the CDEReCATS system to request cGMP declaration for a drug-manufacturing establishment.  Does ...

NMPA issued the "Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)" today (December 13, 2019). Feedbacks need to be submitted by January 13, 2020. Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by China Med Device. As a cost-effective and ...