Markets with No Prior Approvals? Without Country of Origin or other Prior Approval

K

kcovington

#1
Hello all,
I am with a small medical device company focused on emerging markets. We do not yet have US FDA clearance or CE Mark approval. We are working towards building out our full quality system, but do not yet have ISO 13485 certification.

I have seen the list before of no reg countries from Reg Desk. My question is - are there countries where it is possible to submit without country of origin or other prior approval, and without a QMS certificate for a Class IIa device?

We identified Ghana as a market where they do not require home country approval, and perform their own GMP audits. Although it's an atypical path, are there other countries people are aware of that would meet this criteria?
 
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#2
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

A quick "Bump". My Thanks in advance to anyone who can help with this unanswered question. And, should you be browsing threads and find this one, and it still has no reply, if you can help we will all appreciate it.
 
J

jon.loo

#3
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

Is there any region you are looking at? In Singapore and Malaysia, prior regulatory approval is not compulsory, although they approval from GHTF countries does help to qualify your device for a "expedited" approval route with lower requirements
 
S

sweetasheaven

#4
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

Hello all,
I am with a small medical device company focused on emerging markets. We do not yet have US FDA clearance or CE Mark approval. We are working towards building out our full quality system, but do not yet have ISO 13485 certification.

I have seen the list before of no reg countries from Reg Desk. My question is - are there countries where it is possible to submit without country of origin or other prior approval, and without a QMS certificate for a Class IIa device?

We identified Ghana as a market where they do not require home country approval, and perform their own GMP audits. Although it's an atypical path, are there other countries people are aware of that would meet this criteria?
Hi there you can consider going into Thailand at the moment as registration is still quite minimal.
 
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