Tag Archives: product classification

Learn about product classification for medical devices in Asia, focusing on regulatory frameworks, risk levels, & approval strategies with Pacific Bridge Medical.

Malaysia Device Registration: Classify Before You Register

February 28, 2017

By Kandace Nguyen Fu, Senior Vice President of Pacific Bridge Medical Classifying your product as a medical device in Malaysia is an important first step before registering the device. Malaysia’s regulatory system is relatively new and undergoing many changes, so it is... Read More

Chinese Clinical Trials: New GCP Requirements

October 12, 2016

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