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
On April 1, 2009, the Japanese government decided to bring the “me-too” application category back to its medical device registration system. “Me-too” devices are those that are demonstrated to be equivalent to devices that already have market approval in Japan. The enforcement... Read More
On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
India’s government is working on a comprehensive regulatory framework for the medical device sector, which has been lacking a formal regulatory system for many years. Medical devices are currently often regulated as drugs or unregulated. Now, however, India’s health authorities plan to... 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
The Korea Food and Drug Administration (KFDA) is undergoing some reorganization. In his second year at his post, Commissioner Yun Yeo-pyo has decided to restructure the KFDA to improve its efficiency and oversight of food, drug, and medical device safety. New divisions... 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
China’s Center for Drug Evaluation (CDE) under the State Food and Drug Administration (SFDA) has recently released statistics for CDE drug registration approval recommendations in 2008. The CDE reviewed over 25,000 applications, including those for clinical trials, import, and production, but rejected... Read More