Malaysia - Auditor Requires an Updated Audit Report

marmotte

Diapason Consulting
#1
Dear all,

I manufacture a class II/IIa device.
We have a ASEAN distributor with several offices -we deal mostly with Singapore. Their Malaysian office is also our registered agent in Malaysia. I have provided them with (before the june 2016 deadline) the paperwork for the registration there - which has been done from what I know (communication with the Malaysian office is not very good). There has been several updates of this paperwork - at their request. I believe this is because it is something new for them professionally - and their are still quite messy?

Lately, after they have been themselves audited (by the Malaysian authority) they have asked me to update some declarations (Safety) which their template require me to date "between now and five years ago" - even though I had just done one a few months ago ??
A week later, they just asked me to send them our latest AUDIT REPORT - again apparently they are FW'ind a request from the Malaysian authority.

This sounds weird to me - I believe it is not an usual and it is an excessive requirement. I am reluctant to just accept this request, for then in two weeks being asked again some more stuff.

What do you guys think?
 
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shimonv

Trusted Information Resource
#2
Re: Malaysia - Auditor Requires and Updated Audit Report

Hi marmotte,
I am not familiar with the Malaysian regulation but I cannot imagine it being very complicated and demanding.
In my experience, communications and professional issues are very common in these regions.
My advise:
1. Enhance the communicaions with the local office (phone, emails, etc.) and gather every scrap of inoformation. Make sure you have copies of everything they send and receive from the authorities.
2. Give them all they need as long as its not very confidential information that does not make sense in comparison with other markets. Right now you just want over this.

Goodluck,
Shimon
 
#3
Re: Malaysia - Auditor Requires and Updated Audit Report

Dear all,

I manufacture a class II/IIa device.
We have a ASEAN distributor with several offices -we deal mostly with Singapore. Their Malaysian office is also our registered agent in Malaysia. I have provided them with (before the june 2016 deadline) the paperwork for the registration there - which has been done from what I know (communication with the Malaysian office is not very good). There has been several updates of this paperwork - at their request. I believe this is because it is something new for them professionally - and their are still quite messy?

Lately, after they have been themselves audited (by the Malaysian authority) they have asked me to update some declarations (Safety) which their template require me to date "between now and five years ago" - even though I had just done one a few months ago ??
A week later, they just asked me to send them our latest AUDIT REPORT - again apparently they are FW'ind a request from the Malaysian authority.

This sounds weird to me - I believe it is not an usual and it is an excessive requirement. I am reluctant to just accept this request, for then in two weeks being asked again some more stuff.

What do you guys think?
Dear Marmotte,

May I ask that MY is requesting you to submit a CSDT for an active MD? All safety revision as same as DHF, for example a safety test report from original version, may be requested.

Since it is a new system, most of MY importers/distributors have less experience to deal with these tasks. I recommend some help from local Professional Regulatory Consultant firms who knew about both Technical File and CSDT. They should prepare a complete set at the beginning to avoid back and forward communication.

Best Regards from Thailand,
Pete
 

marmotte

Diapason Consulting
#4
Thank you all,
After discussion with my agent there:
1. the agent is currently being audited by the CAB. The CAB has requested them to provide an evidence of a recent audit - hence he had FW'd the request to us.
2. after clarification, the cover page of the audit report or the close out letter were enough for them - I was OK to provide that of course.

THX
 

sreenu927

Quite Involved in Discussions
#5
Hi Marmotte - Yes, that's true. All CABs are/will be audited by MDA. During the audit MDA takes a sample product/company to verify CAB's effectiveness.
If you need any help you can contact me.

Regards,
Sreenu
 
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