May 24, 2016
Mobile health app The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is regulated by the FDA under four...
May 11, 2016
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...
Feb 18, 2016
5 tips for sending your medical device to sanctioned country: Contact OFAC First The most important piece of advice we can give to anyone who is interested in sending their device to a sanctioned country is to schedule a call with Office of Foreign Assets Control...
Jan 19, 2016
The Chinese Food and Drug Administration (CFDA) has issued a new “Medical Equipment Generic Naming Guide,” which will be implemented on April 1, 2016. This is the first regulatory document for ‘naming’ generic medical devices. The CFDA believes...
Jan 13, 2016
On December 30th, the Chinese Food and Drug Administration announced that all the pharmaceutical enterprises who do not pass the newly revised “drug operation quality management practices” (referred to as Drug GSP) ¼Å’are banned from pharmaceutical...