Tag Archives: regulatory affairs

asia R&D growth

Staying Competitive Amid Rapid R&D Growth in Asia

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. From 1970 to 2000, the United States, Europe and, to an extent, Japan dominated the medtech research and development (R&D) world. During this time period, the... Read More

china gcp requirements

Chinese Clinical Trials: New GCP Requirements

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. In late 2014, China announced new medical device regulations. One of the most important new regulations stated that all Class II and Class III devices will... Read More

asia medical device quality assurance

Quality Matters: Do It Right the First Time

By Ames Gross, President and Founder of Pacific Bridge Medical This blog post was also published on MedTech Intelligence. As medtech companies move into the Asian markets, they will find that the Chinese medical device registration process can be very difficult. Today, it is... Read More