When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they... 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
The Taiwanese legislature passed the “Biotech and New Pharmaceutical Development Act” in June 2007. The Act is designed to offer incentives to companies in the pharmaceutical and biotech industry. In one major change, the Act allows publicly-funded researchers to help private companies... Read More
Taiwan’s Department of Health (DOH) plans to introduce a Health Technology Assessment (HTA) system to control rising healthcare costs. This HTA system would require all medical devices, new drugs and innovative surgical procedures to demonstrate effectiveness in improving patients’ health and cutting... Read More
The Bureau of National Health Insurance (BNHI) is facing serious financial problems with a deficit of about $104 million. Last year, the BNHI borrowed $2.3 billion and owed $100 million in interest to pay for healthcare reimbursement. This year, the BNHI has... 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
Taiwan’s Bureau of National Health Insurance (BNHI) plans to change its payment system to a Diagnosis-Related Group (DRG) system in the next year. By establishing this DRG system, the BNHI hopes to decrease waste and improve hospital efficiency. A DRG system means... 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