Taiwan is the most advanced medical device market in Asia with more than 70% market share contributed by foreign manufacturers. Due to its economic performance, rising demand of healthcare products from a rapidly growing aging society as well as National Health Insurance that covers almost all of its 23 million population, the medical device market in Taiwan is projected to grow by over 7% from 2014-2019. This certainly marks Taiwan as one of the most exciting medical device markets for import opportunities.
TGA has recently released its five new Declaration of Conformity templates specifically for IVDs. In this article we outline which template should be used depending on the conformity assessment route taken and the classification of the IVD.
Due to a continuing growth in our client base, we are seeking to expand our China–based team. We seek a team player who brings a well-grounded practical knowledge of regulatory practice, the flexibility to apply their skills across a diverse range of client projects and who has a hunger to learn and grow with the […]
Australia has always been viewed as an attractive market for implantable medical devices. This is due, in a large part, to the Australian Department of Health’s Prostheses List. The Minister of Health, Sussan Ley MP announced initial reforms to the Prostheses List. Guest author Sarah Griffin outlines what this means for medical device manufacturers.
Brandwood Biomedical Founder and Principal Consultant Arthur Brandwood was honoured with a Personal Award for Outstanding Contribution at the China International Medical Device Regulatory Forum in Chengdu.
The US FDA has issued a draft guidance to update and clarify the 510(k) submission decision-making process for manufacturers whose devices have been modified. The guidance follows the controversial 2011 draft, which was withdrawn after Congressional Intervention.