Indonesia Medical Device Product Registration

Ajit Basrur

Staff member
Admin
#11
Hi, this is my 1st post in this forum. First of all, I'll like to thanks everybody for participate and contribute in this very informative forum.

Is the said english version of of Indonesian documents available anywhere in this forum or on the web?

Thank you very much in advance.
Welcome to the Cove :bigwave:

You could refer to this ITA document

Also see :Indonesia Medical Device Product registration
 
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M

MIREGMGR

#12
Heh. The second link in the preceding post of this thread points to...this thread. :rolleyes:

I was all excited, thinking there was going to be a new information source. :)
 

harry

Super Moderator
#14
You could refer to this ITA document
The ITA page from year 2001 is out of date.

It is now under the MOH and controlled by the DG of Pharmaceutical Services & Medical Devices. Problem is, there is English for the MOH page but none for the DG's page.

Attached is a ppt file from year 2006 which may be out of date but nevertheless should give some ideas.

.
 

Attachments

S

shaurya

#19
Hi Tiffany,

This is Shaurya from India. I am doing research on Medical Devices import and distribution in Indonesia and Vietnam. I am looking for regulations and registration process of medical devices in Indonesia.

I read this post from you where you have asked for the same information. So, just wanted to know if you have that information now and if it would be possible for you to share the same with me.

It'll be a great help to me.
Looking forward to your response,
Regards,
Shaurya Varma
 
D

davjger

#20
Can anyone advise if a medical device, provided only as software on a CD, is required to be registered in Indonesia? The Software is installed on the customer's OTS computer. This product is class 2b in the EU.
 
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