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Bangladesh Class IIA Medical Device MDD Registration Requirements

B

Burgmeister

#1
Hi Folks,

looking for more help please. I received an email from our sales director this morning saying that he would like to sell our MDD Class IIa device in Bangladesh. Are there any registration requirements for the Bangladesh market that I need to be aware of?

Thanks
 
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sreenu927

Quite Involved in Discussions
#2
Re: Medical Device registration Bangladesh?

No registration requirements.

However, just from our recent experience, our distributor asked us to provide the technical reports (verification and validation reports), free sales certificate, Certificate of analysis (COA), certificate of conformance (CoC), ISO 13485Certificate docs.

Regards,
Sreenu
 
B

Burgmeister

#3
Thanks Sreenu. Only just noticed that I claimed it was a Class IIa device whereas it is actually a Class IIb device. Does that make any difference?

Thanks
 
N

NobNob

#5
Hi all,

Just a quick bump to know if someone has new information concerning the medical device market in Bangladesh ?

I am looking for some information concerning the medical device registration process (or the absence of this process) in this country but I have found nothing.. :S

Thanks

Best regards
 

Salisburysteve

Starting to get Involved
#6
Hi,

I would like to see if anyone has experience of this. Principally, fees involved and if an 'in-country' rep is needed.

Also, although there is some detail on web documents, I can't find a 'personal import' exemption which some other countries have.

Thanks in advance,

Steve
 
K

katmie

#7
Hi,
I've experienced that there is a registration process for class II medical devices. I was asked for FSC, EC Certificate, marketing history and statement on recalls.
 
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