May 02, 2012
The Health Sciences Authority (HSA),
Singapore, started from 1 May, made all
non-sterile Class A medical device exempted from registration with HSA, but
listing in SMDR is still required.
Starts from 1 September, 2012, Class B
products with at least approval by 2 reference authorities from GHTF members,
i.e. EU, USA, Canada, Australia and Japan without adverse events for 3 years, are
allowed to get immediate registration. Otherwise a 60-day expedited registration
process shall be applied.
For detail please have a look at the HSA website,