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Australia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification.
With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.
On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.
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