www.fdanews.com/articles/152421-singapore-expedites-reviews-of-high-risk-devices
Singapore Expedites Reviews of High-Risk Devices
January 16, 2013
Devicemakers looking to introduce high-risk products in Singapore can now opt for expedited registration reviews. Class C devices can be fast-tracked for approval if they have been approved in the U.S., EU, Australia, Canada or Japan, and Class D devices if approved in at least two of those countries or regions. Excluded from the new pathways are hip, knee and shoulder joint replacement nonbioactive implants.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor