MDSAP

Door closed

The door to Europe is closed – so where else should I look?

By Arthur Brandwood | 2 December, 2019
Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
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Japan renews its participation in MDSAP until 2020

By Luis Jimenez | 2 May, 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...
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Asia-Pacific Med Dev Change Opens Up New Opportunity

By Grant Bennett | 1 May, 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...
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MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)

By Luis Jimenez | 21 December, 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...
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Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP

By Arthur Brandwood | 30 August, 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...

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Recent Posts

Harmonised Standards for MDR? CEN/CENELEC say “Non”

Jul 2, 2020

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

Jul 1, 2020

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

Jun 19, 2020

Proposed delayed commencement of certain Medical Device Regulatory Changes

Jun 12, 2020

Software as a Medical Device – Upcoming Changes to the Australian Regulations

May 29, 2020

Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods

May 19, 2020

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