Before Singapore's Health Products Act 2007, most medical devices did not fall under governmental regulations. From August 1, 2010 onwards, all of these medical devices need to be re-registered under the Health Products Act 2007 guidelines using the online Medical Device Information... Read More
India continues to signal that new medical device regulations are on the horizon. On August 4, 2010, the Central Drugs Standard Control Organization (CDSCO) released online a draft of two different medical device-related documents: the “Guidance Document on Common Submission Format for... Read More
The 2010 Chinese Pharmacopoeia is a new and revised version of the 2005 Chinese Pharmacopoeia. Completed in 2009, it will come into effect October 1, 2010. Manufacturers in each Chinese province are expected to adhere to the contents. One of the most... Read More
Singapore’s Health Sciences Authority (HSA) included secondary assembly activity guidelines in its medical device Technical Specification 01 (TS-01) in early July 2010. Manufacturers that make use of secondary assembly must meet new regulations by August 2011. HSA defines secondary assembly activity as... Read More
On July 19, 2010, the Philippines’ Department of Health signed Administration Ordinance No. 2010-0024. This ordinance requires a new permit (Department of Health Permit to Construct) as a part of the Free-standing Screening Drug Testing Laboratory (free-standing SDTL) Accreditation Process. This ordinance... Read More
In Vietnam, it was recently discovered that a major US drug company was involved with Ho Chi Minh City (HCMC) doctors promoting two types of drugs in exchange for commission. These doctors allegedly accepted kickbacks to prescribe drugs made by Schering-Plough, which... Read More
After a rash of incidents leading to patient deaths in Hong Kong hospitals in 2009, a review committee has developed 75 recommendation points aimed at improving the safety of prescription drugs. Under the Food and Health Bureau (FHB) and Department of Health... 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 these devices. All of these regulations have been marked... Read More
Medical Device Act B.E. 2551 was recently updated in October 2009 with new supplemental laws. These include Premises of Medical Device Manufacturing, Premise of Medical Device Importation, and The Rate of Medical Device Fees. Medical device manufacturers must describe their facility and... Read More
The Ministry of Health (MOH) in China issued new regulations in mid-January 2010 to increase supervision of medical devices in China. Larger hospitals will be required to set up committees to oversee and manage medical device use. In addition, the MOH hopes... Read More