TGA has amended classification regulations for joint replacements to remove discrepancies with Europe, and offers refunds to manufacturers of misclassified ancillary components.
Archives for April 2015
In these days of global clinical trials, most regulators have provisions to accept international clinical data in support of regulatory submissions. New FDA draft guidance seeks to clarify US practice – but does it? And what about the rest of the world?
It seems the Indian Government has deep pockets but short arms. Apparently bureaucratic delays in release of funding are preventing implementation of India’s ambitious regulatory reform Agenda. The Director General is not amused…
IMDRF has released for comment a new guidance on quality systems for Software as a Medical Device. It’s required reading for medical software developers everywhere…
What’s the regulatory fee is a key question when considering a new market. Or is it… ? Factor in review times, market size, pricing, reimbursement and the effects of harmonization, and surprising things happen.
A Chinese saying “the one who tastes the crab first must be a brave person” is nowadays used to refer to the first person to tread a path unknown. Abbott Vascular must like seafood – as they are the first international manufacturer granted access to the new Innovative device registration pathway in China.