K
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?
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?