Bangladesh Class IIA Medical Device MDD Registration Requirements

[Burgmeister]

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

[sreenu927]

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

[Burgmeister]

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

[sreenu927]

No, as of my knowledge. Irrespective of classification, they are interested to verify the mentioned documents.

Regards,
Sreenu