Indonesia Medical Device Product Registration

cmeby

Involved In Discussions
#21
I am also looking for information about registration of a medical device.
Our Imaging Software has ISO 13485 clearance, and FDA clearance.
Does this mean we ensure we have a distributor in Indonesia, and simply register?
Do the same device classifications apply?
Is there any information on Mobile device regulations?
It is very hard to find English information on most of the links and sites.


We have received a request from a customer in Indonesia that is interested in our product...so I would love to get the processes started.
:thanx:
 
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harry

Super Moderator
#22
............................. We have received a request from a customer in Indonesia that is interested in our product...so I would love to get the processes started.
:thanx:
I would suggest that you get this customer to help to do the ground work and facts finding - much easier for locals who understand the language and work-culture of the civil servants there.
 
T

twix38

#25
Hello guys. Can someone advise me if the product registration in Indonesia allows to group a family of devices (e.g., different in size, length, etc) into one application?

I was told by a consultant that it is registered according to per product type/ per Certificate of Free Sale. If this is true, we will have to submit lots of applications (and fees) for the same product brand just because each model has to be registered one by one.
 
T

twix38

#27
Thanks for the information. I couldnt find the part on the grouping of the devices, though. The link on the last paragraph is all in Indonesian language. Can pls help?
 
Y

ymunwai

#28
HI Gopa, I would like to have info on Indonesia medical device regulations but the webpage is in Indonesian. Would you have an English version. I see from your previous post that an English word file is available. thanks.
 

Ronen E

Problem Solver
Staff member
Moderator
#29
HI Gopa, I would like to have info on Indonesia medical device regulations but the webpage is in Indonesian. Would you have an English version. I see from your previous post that an English word file is available. thanks.
Apparently the post that you responded to is from almost 5 years ago, and the poster hasn't logged into Elsmar since that day. :(
 

Murni Ahmad

Involved In Discussions
#30
Apparently the post that you responded to is from almost 5 years ago, and the poster hasn't logged into Elsmar since that day. :(
Apparently im also looking for info on Indonesia...
I will be supporting our branch in Indonesia soon. Appreciate if anyone can share their simplified version of the requirements and documentation for Indonesia registration.

Thank you!
 
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