Singapore Class C Device Registration - Time & Cost?

[Burgmeister]

Morning all.

In early 2010 I started the registration of a Class C device and it took until early 2012 to get final approval. As far as I am aware there were no particular issues with the application. I have now been approached about registering a different Class C device (with a different manufacturer). Was I just unlucky with my 20+ month timescale, or is that the norm? I noticed a thread regarding changes to HSA that should speed up the time taken, but are they up and running yet? If so, have they had any effect?

Basically, has anyone had any experience of registering with HSA recently and how long did it take? Also, does anyone know what the involved costs are?

Thanks in advance of any help.

 

[sreenu927]

Hi,
If the registration dossier is in "good" shape interms of completeness and accuracy, then it won't take 20 m for registration.
Currently, as per HSA regulations, the cost varies from S$3500 - S$6200, depending upon the # of GHTF approvals.
Regarding the processing time, it may take less than an year for a good submission with no or one input request!
If you need further help u can contact me!

Regards,
Sreenu

 

[zhang126]

current official timeline depending on registration route is:

Full: 220 work days

Abridged: 160 wd

Expedited: 120 wd

 

[Burgmeister]

Hi zhang, thanks for that, most helpful