Medical device Product Registration

HnZul

Starting to get Involved
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.
 

HnZul

Starting to get Involved
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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