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Update: PMDA Review Timelines for Medical Device and IVD Products

The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.

UKCA: A Wait and Watch Approach?

On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

Archimed Acquires Majority Interest in NAMSA

Private equity healthcare specialist ArchiMed has acquired from the founding Gorski Family a majority stake in NAMSA, the only full continuum Contract Research Organization (CRO) in the world focused exclusively on medical devices. NAMSA’s President and CEO, John Gorski, the Gorski Family and senior managers will hold stake in the company amounting to a significant double-digit percentage. The price of the transaction is undisclosed.