A suitable supplier network is a business priority, particularly in today’s outsourced environment, but it can sometimes be forgotten that the finished device manufacturer bears the ultimate responsibility for the safety and effectiveness of the device, and is therefore responsible for the selection and management of vendors.
Archives for June 2013
Exporting to Asia Pacific? Join me THIS FRIDAY 21 June at Medilink NW in Stockport for a presentation on market Access in Australia, China and Taiwan. It’s not all doom and gloom. Asian Medtech markets are experiencing robust growth of up to 20% per year (See the article on Asia’s Power markets at http://medtechinsider.com/archives/31390). China […]
Arthur Brandwood to present at ARCS Conference, Sydney 6 June 2013 and at Medilink UK on 21 June 2013.
Currently, a registration certificate in China is valid for 4 years, after which the license must be renewed in order to continue supply in China. The process typically involves review of technical data and often a repeat of type testing. But this is all to change – with a new streamlined process, focussing on product changes, postmarket experience – and no retesting.
Sponsors of a medical device in Australia are responsible for keeping a tab on important financial dates relating to renewals and cancellations of entries included in the Australian Register of Therapeutic Goods (ARTG). This includes acting to ensure that annual fees are paid on time and that devices no longer supplied are cancelled from the register. Fail to cancel and you pay for licenses you don’t need. Fail to pay annual fees and TGA will cancel the inclusion – and stop you selling.
Recently, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) issued a draft bill that proposes to use private accreditation organisations to evaluate certain Class III devices, such as kidney dialysis machines and generic dental implant products. This approach extends Japan’s 3rd party review beyond the current limited set of Class II devices which may be 3rd party approved.