Medical Device Updates and Regulation Changes in Asia
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
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 Filipino FDA held a public consultation on December 3, 2009 for its revised fee schedule. The increased fees are primarily to facilitate the recently approved regulations: the Food and Drugs Administration Act of 2009 and the Universally Accessible Cheaper and Quality... Read More
Hong Kong’s Department of Health (DH) currently has a voluntary registration system under the Medical Device Administration Control (MDACS). DH is currently drafting legislations based on the feedback they have received so far on this MDACS system. In this proposed legislation, all... Read More
China's State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued the... 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
On September 11, 2009, China’s State Food and Drug Administration (SFDA) hosted a Medical Devices Task Force meeting in China. The agenda covered various medical device topics and regulations. For clinical trials, the US encouraged China to adopt a risk based approach... Read More
India’s Central Drugs Standard Control Organization (CDSCO) recently issued the required list of documents needed to conduct bioequivalence studies for export purposes. There have been a growing number of applications filed by manufacturers, importers, and CRO’s requesting approval to carry out BE... Read More
Despite the global economic downturn, the Indian medical devices market is growing at an impressive rate. India has a relatively young population of over 1.1 billion, and its economy has fared relatively well through the global economic crisis. Prime Minister Singh projects... Read More
As part of China’s overhaul of its healthcare system, the government has recently released a list of approximately three hundred medicines that are expected to be sold at government-controlled prices starting in September. The list of essential medicines includes Western medicines such... Read More