By June 30, 2015, foreign medical device manufacturer products must be on Malaysia’s transition list to be sold in Malaysia. In addition, in February of 2015, the Malaysia Medical Device Authority (MDA) published a draft guidance for a proposed system of post-market... Read More
Mandatory Device Registration Coming Soon to Malaysia Read More
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently announced that it would aim for increased speed to market for innovative medical devices and pharmaceuticals. The PMDA plans to complete 70% of device and pharmaceutical reviews within 12 months in 2015– compared... Read More
中国药品市场的改革 Read More
日本：医疗器械和药品审评 Read More
The U.S. and India: Pharmaceutical and Trade Progress Read More
U.S. Food and Drug Administration News Read More
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations. Read More
This presentation provides an overview of the Asian medical device markets and covers important regulatory issues for specific Asian countries, including China, Japan, India, Thailand, and Vietnam. To view these presentation slides, please click on Asia Medical Device Markets Overview Presentation Table of... Read More
China's medical device and IVD market has grown to over $20 billion, the third largest in the world. The number of foreign medical device manufacturers registering their products in China has grown exponentially. To be successful in this fast growing market, view... Read More