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

K

kcovington

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?
 

Marc

Fully vaccinated are you?
Leader
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

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

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.
 

Nipun Kumar A

Registered
Hello Team,

Whether Bahamas and Barbados need any special approval and additional certifications for introducing a Class II device? This product is already FDA approved and CE marked also.
 

MadRob

Registered
Bumping this up, as I am in a similar circumstance, @Nipun Kumar A and have not been able to find almost any information on Barbados registration procedures for devices!
 
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