Luis Jimenez


Japan renews its participation in MDSAP until 2020

Japan’s participation in MDSAP (Medical Device Standardized Audit Program) has been a contributing factor in the exponential update of MDSAP by multinational companies. Japan’s MHLW and PMDA has been opting...
Distribution copy

The commercialization continuum: beyond product registrations

Your product is approved, now what? This is a question that can bring a painful realization to medical technology manufacturers and suppliers eagerly entering a new market. The appropriate preparation...
MDSAP article image

MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)

On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to...

Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry. Many, if...

Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

TGA issues international collaboration guidelines for review of pharma applications

New guidelines for collaboration with overseas regulators were issued on June 15th 2018 by the TGA. Australia’s Therapeutic Good Administration (TGA) has issued a guidance for a framework to enable...


Recent Posts