Question on Authorized Representative (Malaysia)

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sreenu927

Quite Involved in Discussions
#12
Hi,
Is there any update from Malaysian Regulatory Authority on extension of transition period for product registration. The initial 2 years transition ends by 30 June 2015; however, most of the Companies did not get their Conformity Assessment Body (CAB) certification, due to fewer number of CABs.
So is MDA extending the timeline?
Any update is appreciated.

Thanks,
Sreenu
 

Murni Ahmad

Involved In Discussions
#13
Hi,
Is there any update from Malaysian Regulatory Authority on extension of transition period for product registration. The initial 2 years transition ends by 30 June 2015; however, most of the Companies did not get their Conformity Assessment Body (CAB) certification, due to fewer number of CABs.
So is MDA extending the timeline?
Any update is appreciated.

Thanks,
Sreenu
Hi Sreenu,

No extension given so far, but new guidance has been published by MDA, called Fast-Track registration.
It allows you to submit your product registration without CAB reports, and will be issued temporary registration, and you will be given 3 years to appoint CAB and update your CAB report to MDA. This advantage applied only for GTHF countries product.
 
Last edited:
#14
I am Ranjit from Technosyscon Consultants Pune. I have a few clients from medical device manufacturing who are looking to expand their customers in Malaysian market. I went through the approval procedure and documents required but couldn't find anything related to how much fees do the CAB charge for the approval process. If you can give me a rough estimate it would be helpful.

BR
Ranjit
 

Murni Ahmad

Involved In Discussions
#15
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
 
Last edited:
J

jon.loo

#16
CAB cost depends on each CAB and your negotiation.
Medical Device Authority application fees and registration fees are published on the fifth schedule of the Malaysia Medical Device Regulations.
 
#17
CAB cost depends on each CAB and your negotiation.
Medical Device Authority application fees and registration fees are published on the fifth schedule of the Malaysia Medical Device Regulations.
Depending on your experience what will a rough cost of CAB for: class a: full conformity assessment=?, product verification=?, class b: full conformity assessment=?, product verification=?, class c: full conformity assessment=?, product verification=?, class d: full conformity assessment=?, product verification=?,
 
#18
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
Extremely helpful and very detail oriented answer. I am very thankful for valuable insight. i am getting more and more inquiries from clients who are from wide class of medical devices. And everything has now come to cost after your pointers. Depending on your experience what will a rough cost of CAB for: class a: full conformity assessment=?, product verification=?, class b: full conformity assessment=?, product verification=?, class c: full conformity assessment=?, product verification=?, class d: full conformity assessment=?, product verification=? Please guide me through this. Thanks in advance.
 

Murni Ahmad

Involved In Discussions
#19
Hi Ranjit,

Sorry for this late reply. I have no definite answers to that, you can ask the CAB to send a proposal or quotation, also you might want to know how efficient are they, considering most of CAB is now busy with the end of transition and the coming mandatory registration.
 
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