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.

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.
