Hi Ranjit,
I assume by asking on the fees by CAB, you have yet to have an office in Malaysia.
Through my experience, the following are some tips for you
To have a AR,
1. Appoint a local company, and will be easier if you get existing local AR covering activities you need eg: Some AR focus only on registration and licensing, some offer Post Market, some offer servicing if instrument/machine involved.
or
2. Set up a local office as AR (for foreign company), implement GDPMD (a QMS almost similar to ISO9001), hire a CAB to conduct conformity assessment for GDPMD certification. Once you get GDPMD certification then you can apply for establishment license from Medical Device Authority Malaysia through MedCast
3. How long to get GDPMD- mine is 1 year from zero to hero ;p
4. How much the cost for GDPMD certification- depends on CAB, the activities and the headcount, and no harm to ask CAB to prepare quotation/ proposal for you to choose - 50 headcounts usually around RM10K per audit, and they performed audit every year for the first 3 years.
5. How much the cost for MDA license - application fee+license fee roughly RM 5000, valid for 3 years
AR register the product,
1. Get your dossier ready by preparing the CSDT and supporting document as outlined in guidances and MedCast system
2. Hire a CAB to do product verification for your registration dossier, once approved, you can submit the dossier and CAB report through MedCast and wait for MDA approval.
3. How long the process - from CAB to MDA approval takes about 6 months-1 year roughly through my experience, provided complete dossier given, also depends on the product class
4. How much is the overall cost - for MDA, based on the class too, for application fee+registration fee, please refer to MDR2012. for CAB, stated in circular is recommended RM500 per product verification, but bear in mind that its not mandatory to follow, also need to add in management and certificate fees by CAB.
That is all i can think of right now, hope its help, ill come back again if i managed to get proper place to sit and brainstorming everything.. its weekend here ;p
Happy Weekend to you reader!
Thank you,
Murni