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Countries that require minimal Medical Device Registration

#1
Hi Everybody,:bigwave:

Can anyone advise on countries (worldwide) that do not require or have minimal registration requirements allowing importation and sale for medical devices (EU class IIa or lower).

Not including Europe!

Thanks
 
#2
Re: Countries that require minimal registration

What do you mean by "minimal" - no regulation? Submission of a few forms? EU class I equivalent?

Does your product already carry a CE mark? or has it undergone 510k/PMA in the US? - some markets accept EU/FDA approval etc with what I would deem to be "minimal" additional effort
 
#3
Re: Countries that require minimal registration

Yes, it is for CE marked products and I am looking to expand globally, so want to go for countries where an expedited registration is possible, alternatively submission of a few forms.
 

Mikilk

Involved In Discussions
#4
Re: Countries that require minimal registration

is it an active device? sterile? have you done market research to understand the potential markets?
you have countries like Thailand, Jordan and South Africa that are "easier" (I'm trying to be careful as you still need a registration, and it is still a process). we are doing it a lot but its depend on the type of device.
Miki
 

tibon74

Involved In Discussions
#5
Re: Countries that require minimal registration

Hello,

Does someone have information about medical device registration in Jordan?
thank you!
 

Mikilk

Involved In Discussions
#6
Re: Countries that require minimal registration

Hello,

Does someone have information about medical device registration in Jordan?
thank you!
Yes
MD Registration in Jordan consist should be sent to MOH, based on CE / FDA certificate.
timeline for getting the license is - 4-8 months (depends on lab testing if required)
you should register the manufacture and products - through local representative
that is Assigned as a local regulatory authorized Representative and license holder. -

if you need any further information, Please do not hesitate to contact me
 
Last edited by a moderator:

tibon74

Involved In Discussions
#7
Re: Countries that require minimal registration

thank you !
do you have more information on needed documents ?
All manufacturing sites must be registered or only legal manufacturer ?
Are there medical device classes like in Europe (I, IIa, IIb, III)? Should we approve I and IIa classes ?
thank you !
 
M

MMBer

#8
There is an article discussing countries with minimal medical device requirements at regdesk. It is titled "List of Countries with NO Formal Regulatory Approval Process"
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Super Moderator
#9
There is an article discussing countries with minimal medical device requirements at regdesk. It is titled "List of Countries with NO Formal Regulatory Approval Process"
Thanks for the reference, I inserted a quick link to that article.

Are you related to Regdesk in some way?
 
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