Asia #WebinarWednesday is back! Join us on January 23rd at 11am EST to discuss South Korea’s medical device regulations and registration processes with our guest speaker Yoojin Ahn, a leading regulatory affairs and quality assurance expert based in Anyang-si, South Korea....
Consultant Post by Tunika Onnekikami As part of RegDesk’s October webinar, Nikolay Ryashin, the director of a large regulatory consulting firm in Russia, gave an overview of the Russian and EEU regulatory landscape. Explaining how regulatory changes would impact foreign...
Consultant Post by Tunika Onnekikami New guidance document In September 2017, the Food and Drug Administration (FDA) released a guidance document to provide support and clarity for “Developing and Responding to Deficiencies in Accordance with the Least Burdensome...
Consultant Post China has become the second largest medical device market in the world. Sustained economy, population growth and a burgeoning aging population makes China a lucrative market for foreign medical device and pharmaceutical manufacturers. Nevertheless, China is considered...
Africa Karen M, one of our Switzerland-based consultants, recently shared her insights into emerging markets of medical device with us. Here are Karen’s five tips to consider before sending your product to a new or developing market: Understand existing regulations...
Consultant Post Katrina is a U.S. medical device regulations consultant on the east coast with in-depth knowledge of the Medical Device Industry. Katrina has been a consultant with RegDesk for a while now and we recently had the chance to catch up! REGDESK: Did you have any...
