In today's global recession, innovation, creativity and resourcefulness are essential. Using these tools to determine the appropriate regulatory strategy for your medical device could decide the success or failure of your product in Asia. This article provides the most recent regulatory updates... Read More
The United States and Japan issued a report detailing the progress of the US-Japan Regulatory Reform and Competition Policy Initiative. The Initiative was established to encourage fairer competition, improve the business environment in Japan, and promote bilateral economic growth through regulatory reform.... Read More
The Drug Controller Governor of India (DCGI) plans to put together an official national list of pharmaceutical manufacturers that are licensed in India. Additionally, the DCGI will use a software program to keep an updated computer database of these companies. State drug... Read More
The Association of Southeast Asian Nations (ASEAN) countries gathered for five days from May 25-29, 2009 for the 16th Meeting of the ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group (ACCSQ PPWG). The event was held in the Philippines, and... Read More
In June 2009 the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical device sector. The new regulations have been sent to the Ministry of Health for final notification, which is expected soon.... Read More
As previously reported in our Asia Medical eNewsletter, the Taiwan Food and Drug Administration (TFDA) will combine the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs in order to better integrate... Read More
India combines many opportunities and many challenges for the medical device industry. India’s medical device market is currently the fourth largest market in Asia. With projected growth rates of 12-16% for the next five years, one cannot ignore India’s potential and vast... Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has discussed with the Ministry of Health, Labor and Welfare (MHLW) on how to implement international activities for pharmaceuticals and medical devices in the future. They have formulated a framework for international activities and posted... 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