Requirements for sending Medical Device Samples to Indonesia

[EyesWideOpen]

Hi,

We are considering registration in Indonesia and would like to send some device samples to prospective distributors prior to beginning the registration. Can samples be sent into the country for evaluation purposes prior to a registration being started?

The only information I could find on Medical Device samples is in the ASEAN Med Dev Directive on labeling samples, but it's not in effect and I can't find anything else specific to Indonesia.

Thanks,

Will

 

[Pads38]

I can not offer much help but..

Check Rob's thread here:
Worldwide device regulatory authorities at country level

The Indonesia page has a web address to follow. Lots of information there - in Indonesian.

 

[LFZR88]

Hi Will,

Medical devices definitely need registration before they can be sold in Indonesia. your distributors also need a licence (IPAK) However it does depend on how you are planning to send the devices? I am assuming they are implantable? - you could possibly look at sending non sterile devices clearly labelled non sterile, not for clinical use, I would speak with the distributors to get a clear view of what is acceptable as local knowledge is key.

 

[EyesWideOpen]

Thanks for the help. They're not implantable, just an IVD test. At this point we're just wanting to supply a non-clinical use demo sample for a distributor, not sell any product.

Our distribution management group asked the prospective distributor who said the registration would have to be started before demo samples could be sent, but the internal DM group didn't like this response so they've come to regulatory for more information.

 

[LFZR88]

Ok you need to speak directly with the distributor, not get this information 2nd hand, this is what I always do, especially as there is some doubt - what do they mean by "the registration has to be started" this could mean something relatively simple or committing to a full registration, Indonesia is common submission which is fairly weighty regs timewise, but the distributor may just be trying to get a commitment from your company to continue with them, as I think you mentioned distributors - as in you are speaking to a few, ask the question to several of them and see what they say.

 

[EyesWideOpen]

I totally agree. Our distribution management group is making it difficult for us to speak directly with their potential distributors, so I'll have to see how it plays out politically. Thanks for the great advice!