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
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 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
On February 12, 2007, the Singapore Parliament passed the Health Products Act 2007 into law. This represents a major change to Singapore’s regulatory system, bringing a number of medical products under mandatory regulation, starting with medical devices. Previously, medical devices were registered... 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
In January 2007, the revised International Code of Pharmaceutical Marketing Practices developed by the International Federation of Pharmaceutical Manufacturers & Association (IFPMA) became effective. Though the Singapore Association of Pharmaceutical Industries (SAPI) is part of the IFPMA, it has only recently stated... 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
With steadily increasing drug development costs and significant time spent on clinical trials, outsourcing clinical trials in Asia has rapidly become an appealing option for many firms. As developing a single drug can cost more than $200 million and take at least... Read More
The Singapore Parliament is conducting a preliminary review on new legislation to regulate all health products and active ingredients. The Health Products Bill was first presented to the Parliament on January 22, 2007. It seeks to regulate the manufacture, import, supply, presentation,... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More