The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
This fall, India has announced plans to replace its current Central Drugs Standard Control Organization (CDSCO) with a new agency, the Central Drugs Authority of India (CDAI). The government hopes that the CDAI will help centralize the product approval process and improve... Read More
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and... Read More
In August 2007, China’s State Food and Drug Administration (SFDA) issued six Working Procedures, laying out how it would conduct various procedural requests about medical device product registrations. The most notable of these was a detailed description of how to apply for... Read More
Japan's long recession is over. After a frustrating period of starts, stops, and even reverses in economic growth (1990-2002), Japan's GDP growth has stayed near or above 2% since 2003. With its affluent and aging population, Japan is the second-largest medical market... 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 Central Government in India has recently drafted legislation to ensure quality control of vital life-saving medical devices such as endoscopes and pacemakers. Drafted by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, the draft has been forwarded to the... Read More
Recent reports on counterfeit drugs in Thailand have prompted several government agencies, including the Intellectual Property Department, to investigate and crack down on fake drugs. The Food and Drug Administration (FDA) in Thailand said that over 30 sellers of fake drugs were... Read More
Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing... Read More