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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

As the global economic crisis deepens, China is entering a new phase in its development. Its exports, economic growth, and employment levels are all falling. It is, however, important for Western businesses to keep these changes in perspective. China's gross domestic product... Read More

Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More

Singapore’s Health Sciences Authority (HSA) drafted a stricter set of guidelines in October 2008 for advertising and promoting medical devices in Singapore. These new guidelines coincide with Singapore’s recent implementation of an updated medical device regulation framework. They are meant to complement... Read More

Thailand’s Food and Drug Administration (FDA) has recently held meetings to discuss methods of improving supervision of post-market surveillance and medical product advertising. The Medical Device Control Division of the Thai FDA held a seminar in Bangkok on June 3rd and 4th,... Read More

Thailand’s Food and Drug Administration (FDA) has recently implemented a new law, Medical Device Act B.E. 2551, to replace Medical Device Act B.E. 2531. This new Act details regulations and requirements for product registration, advertisements, and punishments for non-compliance. The Act defines... Read More

China’s State Food and Drug Administration (SFDA) has recently issued various laws to regulate more stringently quality control in the medical market. The US Department of Health and Human Services (HHS) is also helping China improve its medical market. The HHS and... Read More

The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries.... Read More

The Indonesian Health Minister has set a deadline of August 2006 for full compliance with a ministerial decree regarding drug labeling requirements. Ministerial Decree 68/2006 requires drug companies to print generic names and retail prices on packaging for all branded drugs. The... Read More

Japan’s new Pharmaceutical Affairs Law (PAL), effective as of April 1, 2005, outlines the new post-marketing safety measures, also known as Good Vigilance Practice (GVP). This regulation clarifies the responsibilities of distributors of medical devices, drugs, quasi-drugs, and cosmetic products. All Marketing... Read More