Medical Device Registration in Saudi Arabia

TomQA

Involved In Discussions
Hello,
I work for a Swiss company and we would like to register one of our products in Saudi Arabia using the simplified GHTF route (our product is CE marked) but I have certains issues/questions.
- Our device is currently a class I software according to MDD 93/42/EEC classification rules (it is not MDR compliant)
However, according to the SFDA classification rules (which are identical to MDR), our medical device is considered as a class IIa / class B . And registration in SFDA requires us to sign an SFDA Declaration of conformity (DoC) stating the SFDA class (IIa/B) in addition to the EU DoC (class I EU / classA SFDA).
Therefore I feel that the GHTF route is not possbile for us due to the discrepancy between the two DoC.
What is your opinion on this ?
Thank you very much!
 

ralfie874

Registered
Unfortunately the GHTF route is not longer accepted. You would have to use the Technical File (Assessment) route.
 

ZIK1971

Registered
Hello, anyone here have any idea if we can register products with SFDA in Saudi Arabia, without CE or USFDA,
Can we only use "Technical Files" if Manufacturer is from Non-EU, require some information about it.
 
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