Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
Asia
In April, China was hit by a vaccine scandal that has since resulted in a shortage of supply. Thousands of vaccine doses for children and adults were found to be improperly stored or expired. The vaccines were illegally sold for millions of dollars on the black...
Europe
The Ministry of Health of the Russian Federation is the country’s regulatory body for healthcare concerns. They recently released a change in regulation for medical devices. All Medical Device Registration Licenses issued from 1 January 2007 to 31 December 2012...
Asia
The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of medical device clinical trials and devices that may be...
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...
