Intended use - Taiwan

#1
Dear All,
I posted not too long ago a question concerning a difficulty we are experiencing in registering a new RF based device in Taiwan:

Long time ago our EU NB advised us during a submission of a new device class IIB that we amend the intended users section in the IFU from:

Intended users: Healthcare professionals

To:
Intended users: Healthcare professionals (Doctors or Nurses)

Meaning to add Dr and nurses.

We are now facing some RA difficulties in Taiwan requesting to omit Dr and Nursed.

We came to know that our NB requested that we explain what does it mean "Health care professionals" and we replied "doctors and nurse, meaning it was their request.

Provided we dont wish to create a special configuration fso that the same device bearing the Medical CE will be also sold in Taiwan:

  • If Taiwan doesn’t need the Medical CE for registration, but its still there, are we allowed to create a separate IFU with or without the CE medical with their requested intended use and add it to the machine which bears the Medical CE mark?
  • If they need the medical CE mark, it means that the IFU must be with the CE mark as well with the same intended use as in Europe even though its sold outside of the EU?
Thanks
Udi
 
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monoj mon

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#2
  • If Taiwan doesn’t need the Medical CE for registration, but its still there, are we allowed to create a separate IFU with or without the CE medical with their requested intended use and add it to the machine which bears the Medical CE mark?
  • If they need the medical CE mark, it means that the IFU must be with the CE mark as well with the same intended use as in Europe even though its sold outside of the EU?
Although I don't directly handle our products' approval in Taiwan, but I do contribute (time to time) by preparing some of the summary documents for our products' (without CE mark or 510k) approval in Taiwan. Based on my experience, you can submit your application independent of your CE status. I assume, you are aware of the fact that you will need to write almost everything in Chinese! Specially the Labeling. If you submit your application independent of CE or 510k, you may need to provide similar amount of documents you provided for CE, including a well-written Clinical Evaluation Summary. While submitting, you can try providing information about your CE status (including your CE mark on the labels/IFUs) and consult with TFDA reviewers about it.
 

Sicco

Involved In Discussions
#3
Hi Udi,
there shouldn't be a problem to prepare different version - with labelling without the CE mark - it is also your protection because you could face some obstacles if such device would be re-sale to Europe (this is not so probably but it could happen)
 
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