China’s Food and Drug Administration (CFDA) has already started shifting multiple inspection and approval authorities to its regional FDA offices. The changes, mandated under the CFDA’s May 15, 2013 restructuring plan, are to be completed by the end of 2013 at the... Read More
A proposed bill from India’s Ministry of Health (MOH) would — for the first time ever — require the comprehensive regulation of all medical devices manufactured in or imported into India. On July 11, the Union Cabinet approved the Drugs and Cosmetics... Read More
Together, the ten countries of the Association of Southeast Asian Nations (ASEAN) have a combined GDP of $2 trillion and a population of more than 600 million. Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Myanmar (Burma), Cambodia, Laos and Vietnam made up... Read More
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More
Previously, China was associated primarily with low tech components and disposable medical devices. But over the last five years, Chinese manufacturers have made considerable strides in both medical technology and product quality. High end products like diagnostic imaging technology can now be... Read More
Despite a recent drop in economic growth, China's economy is still growing. GDP growth in 2013 is expected to reach 7.3 percent, higher than anywhere in Asia. China's medical device market is currently the sixth largest in the world. If current growth... Read More
With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which... Read More
China is considering requiring more local clinical trials for medical device approval. The Regulation on Supervision and Administration of Medical Devices, passed in 2000 and updated in 2004 and 2007, was largely a reflection of U.S. Food and Drug Administration (FDA) practices.... Read More
The India Pharmaceutical Regulatory Report comprehensively covers all aspects of India pharmaceutical regulations. It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. It also includes an overview of the... Read More
China’s State Food and Drug Administration (SFDA) and the Guangdong Provincial Government recently signed an agreement establishing Guangdong as a priority area for pharmaceutical technology transfer, drug manufacturing technology transfer, and inter-provincial manufacturing consignment. The agreement gives Guangdong’s provincial government powers to... Read More