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FDAnews Device Daily Bulletin

Singapore Launches Device Priority Reviews, Pre-Market Consultations

Sept. 5, 2017

Singapore is introducing a pre-market consultation scheme and a priority review mechanism for medical devices in an effort to attract more devicemakers and bring more novel devices to market.

The Medical Devices Branch of Singapore’s Health Sciences Authority began accepting priority review applications for medical devices Aug 1. Class A devices and those incorporating medicinal products are not eligible for the priority review scheme.

Devices can qualify for the priority review pathway if they address priority healthcare areas or are designed and validated to meet unmet clinical needs.

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