The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
The Health Sciences Authority (HSA) of Singapore has recently issued various Guidance Document drafts on their website. As described in Volume 7, Issue No. 10, Singapore passed its Health Products Act in February 2007 to regulate all medical products, including medical devices.... Read More
Asia's growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India's GDP figures progressed from 7% to 9% over the same period. These countries' medical device markets are... Read More
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