The European Medical Device and Active Implantable Medical Device Directives have for more than 20 years provided the “best practice” regulatory model which has been adapted into so many other markets around the world. But now Europe has changed. How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world? Is this new global disharmony a threat – or can others follow Europe’s lead and take the opportunity to deliver a more harmonised global regulation?
European Parliament today adopted the MDR, IVDR – setting up a publication within the month and a transitional period ending May 2020 for full implementation of the new regulations.
The Australian Senate Community Affairs Committee has recommended that parliament pass amendments to the Therapeutic Goods Act to implement reforms arising from the Sansom review.
The amendments pave the way for some key changes including introduction of Australian Conformity Assessment Bodies
In a quiet announcement from China’s Ministry of Finance last week, the Chinese government cancelled an array of administrative charges – including for drug and medical deice testing. Already type testing centres are cancelling charges, but there are traps here which may slow down testing processes
China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
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.