×

MDSAP

shutterstock_552100717

Japan renews its participation in MDSAP until 2020

By Luis Jimenez | 05.02.2019
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...
Asia Pacific flags

Asia-Pacific Med Dev Change Opens Up New Opportunity

By Grant Bennett | 05.01.2019
Rapid regulatory change is normal in the emerging (and established) medical device markets of the Asia Pacific. Substantial changes in 2018 were no exception, including in some cases, whole new...
MDSAP article image

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

By Luis Jimenez | 12.21.2018
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...
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

Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP

By Arthur Brandwood | 08.30.2018
Australia’s regulatory system is modelled very closely on that of Europe. This equivalence of requirements and assessment pathways has allowed TGA to leverage prior CE marking to grant Australian device...

Search

Recent Posts

Australian TGA To Introduce AusUDI

Aug 19, 2019

Cybersecurity – Is Your Device Software Secure?

Aug 13, 2019

Inaugural Course on Molecular Toxicology

Aug 5, 2019

Beyond a business merger, diverse skills come together at Brandwood CKC

Aug 5, 2019

Applications Closing Soon – November PL.

Aug 1, 2019

Importance of Innovation

Jul 29, 2019

Categories

Categories

Archives

Archives

Archives

Tags

3D 3D printing 510(k) 510(k) PMA adverse events Apple Watch Artificial Intelligence Australia Biocompatibility Biomechanics Brexit CE CE Certificates CFDA China clinical evidence distribution Europe FDA Health Canada IVD IVDR MDR MDSAP mechanical properties medical device medical devices New Zealand Notified Bodies PMA PMDA post market postmarket premarket Quality Systems Reform regulatory Reimbursement SaMD Software standards Sterilisation TGA UDI Webinar
Translate »