China’s State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for sterile and implantable medical devices. All of these regulations... Read More
The Drug Controller General of India (DCGI) plans to revive the pharmacovigilance program initially launched in 2004, after holding a workshop on December 29 and 30, 2009. About 20 centers were open to record adverse drug reactions but the program has been... Read More
China’s State Food and Drug Administration (SFDA) issued new plans for ensuring the quality of essential drugs on November 25, 2009. All provincial food and drug administrations will need to focus on strengthening essential drug production and quality control supervision work. They... Read More
India’s Central Drugs Standard Control Organization (CDSCO) is increasing its supervision on spurious medical products by conducting a nationwide survey to assess the extent of availability of spurious drugs. They have drawn samples from different regions and these samples are currently being... Read More
More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be... Read More
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
In March 2009, a series of blunders in Hong Kong’s drug industry shook up the public’s confidence in the safety of their drugs. This scandal involved expired medicines, illegal packaging, fake expiry dates on drugs, and an illegal level of fungi in... 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
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
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