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Question on Authorized Representative in Malaysia

#1
Hi everybody, I'm part of the Legal Department of an Argentinian medical device manofacturer and we have a question about authorized representative in Malaysia.

One of our distributor registered our products in Malaysia as authorized representative. Now we want to start a business relationship with other distributor and there is no chance that the previous one gives this latter an autorization. So, are there any ideas on how to appoint the new distributor? The registrations are exclusives? Can a registration be revoke?

Any information would be welcome, thank you all!
 
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Sicco

Involved In Discussions
#2
I suppose you have to issue an authorisation letter to your original distributor so I suppose -
1) this letter is time limited,
2) the registration is also time limited (for 5 years)
3) there could be possibility to revoke your current authorisation
 

Murni Ahmad

Involved In Discussions
#3
Hi everybody, I'm part of the Legal Department of an Argentinian medical device manofacturer and we have a question about authorized representative in Malaysia.

One of our distributor registered our products in Malaysia as authorized representative. Now we want to start a business relationship with other distributor and there is no chance that the previous one gives this latter an autorization. So, are there any ideas on how to appoint the new distributor? The registrations are exclusives? Can a registration be revoke?

Any information would be welcome, thank you all!
Hi there,

Registration can be revoked, tricky part if you want to transfer to a new AR
Involving a good understanding with the current AR

You can also have multiple AR, but must carrying/registering different products.
Only 1 AR for 1 product - ideally.

To appoint, just issue a LOA, ensure you AR registered with MDA.
 

Jen

Starting to get Involved
#4
Hi everybody, I'm part of the Legal Department of an Argentinian medical device manofacturer and we have a question about authorized representative in Malaysia.

One of our distributor registered our products in Malaysia as authorized representative. Now we want to start a business relationship with other distributor and there is no chance that the previous one gives this latter an autorization. So, are there any ideas on how to appoint the new distributor? The registrations are exclusives? Can a registration be revoke?

Any information would be welcome, thank you all!
Attached is the guidance doc for change of ownership in Malaysia. Hope it can help.
 

Attachments

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