The Drug Controller General of India (DCGI) has decided to make registration of clinical trials mandatory starting June 15, 2009. Therefore, any clinical trials initiated after this date will require registration through the Clinical Trials Registry – India (CTRI). CTRI was set... Read More
Vietnam is currently attracting a great deal of foreign investment, especially from foreign medical device manufacturers that are relocating due to rising wages in coastal and southern China. American and European medical device makers dominate the market, but more and more global... Read More
In a move that is likely to ease the way for foreign medical device manufacturers, the KFDA is planning to eliminate certain requirements for certificates of product approval. Manufacturers must currently submit a copy of the product approval in the country of... Read More
There is no doubt that China is and will continue to be a global hotspot for the medical industry. Yet many Western companies that rush haphazardly into China without fully understanding its business culture and mentality ultimately meet with failure. This presentation... Read More
Without a proper understanding of Japan's regulations and cultural differences, companies could fail to get their products registered in that nation. As more and more companies have faced QMS audits, a better understanding of the process has emerged. This article describes several... Read More
In February 2009, Thailand’s “Liability for Damages Arising from Unsafe Products Act” came into effect. Drug and device manufacturers selling products in Thailand will need to be aware of the changes in the legal system. Liability of unsafe products will change drastically... Read More
Vietnam has recently moved to enhance its medical device regulatory system. While imported medical devices do not need to be registered in Vietnam to be marketed, they do require an import license. First-time device imports that use a novel method of diagnosis... Read More
The Thai Food and Drug Administration (FDA) recently implemented a new phase of its Medical Device Act. This phase is the transfer of some regulatory powers to the provincial governments. Thailand’s new Medical Device Act went into effect in 2008, overhauling Thailand’s... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More
In November 2008, Japan’s Ministry of Health, Labor and Welfare (MHLW) released its slated 2009 revisions to the Good Clinical Practice (GCP) standards governing clinical trials for medical devices in Japan. Almost identical revisions to GCP for drugs were implemented in April... Read More