Hi Barry,
I have had luck in the past using the EU Essential Requirements for Singapore, but I have not submitted a new application in the past year.
Singapore also offers expedited routes which leverage Australia, the EU or other markets which may help: https://www.hsa.gov.sg/medical-devices/registration/overview.
Best of luck,
Liz
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Elizabeth Goldstein RAC
Regulatory Affairs Manager-International
Irvine CA
United States
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Original Message:
Sent: 10-Nov-2021 02:10
From: Barry Evers-Buckland
Subject: Singapore
Does anyone know if you can use a European Essential Requirements or and Australian TGA Essential Principle document as a substitute for the ASEAN EP when submitting a registration in Singapore.
Thanks
Barry
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Barry Evers-Buckland
Director
Eltham North VIC
Australia
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