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Medical device Product Registration

#1
Hi Everyone!

As a new comer in Medical Device Regulatory, I would like to ask about product registration process.
If I have Product A and we are planning to have several supplier for our device components. Component 1 from Company X, component 1 from Company Y.
So do I have to register Product A (using component from Company X) as one registration. And another registration for Product A (using component from company Y).
or I can have both components in one registration submission?

Situation is, component from both company might be differ in quality grade and price. But they are from same material.

Thanks in advance for your responses.
 
Elsmar Forum Sponsor
#3
For now we are planning for Asia Pacific region only. So does it depending on which country we are planning to market our device?
 
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