Since 2000, China’s State Food and Drug Administration (SFDA) classified registered medical devices into Classes I, II, and III according to the intended use of the medical device and the risks associated with its use. The SFDA recently adjusted their medical device... Read More
Like many other Asian countries, Hong Kong is developing a more regulated, harmonized system for medical device manufacturers and importers. Though registration is currently voluntary, manufacturers will soon be required to register their products. Get a head start by viewing our webcast... Read More
The Indonesian pharmaceutical market was estimated to be around US$4 billion in 2011. The countrys pharmaceutical market has been steadily growing. Along with increased domestic demand, sales of prescription drugs are expected to grow approximately 12% in 2012, according to IMS Health... Read More
China's pharmaceutical market is currently the ninth largest worldwide and worth approximately $25 billion. With analysts predicting this market to be the fifth largest by 2013, one cannot ignore China's potential. This webcast will provide an overview of drug registration in China... Read More
On November 24, 2011, the Chinese SFDA announced the Notice for Clinical Trial Waiver Concerning Certain Class II Devices, effective immediately. The notice lists 21 types of Class II devices eligible for waiver of local registration trials. Applicants seeking the waiver must... Read More
The Vietnam medical device market is growing very quickly. To succeed there, foreign medical device companies need to understand the Vietnamese regulatory system and how to get product approval. Read More
The Korea Food and Drug Association (KFDA) recently revised the classification of six medicines. Two over-the-counter (OTC) drugs were re-categorized as prescription drugs, while two previously prescription drugs can now be sold at pharmacies OTC. Classifications of 11 other drugs... Read More
The Thailand medical device market is current valued at $800 million and is quickly growing. It is expected to expand at about 8% annually over the next 5 years. Meanwhile, the Thai government continues to support a universal healthcare system. Since April... Read More
Singapore passed the Health Products Act in February 2007. This Act has been implemented in stages throughout the past few years. Under this Act, all Class A-D products require Singapore medical device registration with the Singapore HSA. Also, manufacturers, dealers, importers and... Read More
Hong Kong's government currently does not strictly regulate most medical devices. In August 2010, Hong Kong's Medical Device Control Office proposed its framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. There are many similarities to the... Read More