Device Description in CSDT Format - Medical Device Instructions for Use (IFU)

[LQ. Fanny Lozano]

Dear all,

Hope you can help me out on this one. The CSDT format for Medical Devices asks for "Instructions for Use (IFU)" of the medical device. In our case, the medical devices we are pretending to submit due to their nature they don't nee from an Instructive as such, so here in our country they are registered without an Instructive but still we have all the information contained on the IFU.
On section 4.4 DEVICE LABELLING in the point 4.4.2 an IFU must be given but as I told you before, we don't have one.
So my question is: Is it OK if I present the IFU just "as it is" like a summary on a Word document or shall I make an IFU specially for this purpose??
Could anyone tell me something concerning to this case?? Has somebody gone through this same problem??

Thank you for attention!! Regards

 

[Stijloor]

A Quick Bump!

Can someone help with this?

Thank you very much!

Stijloor.

 

[Marc]

Another quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[MIREGMGR]

...CSDT format for Medical Devices

CSDT is defined in Guidance GN-17 for general devices, and GN-18 for IVDs. These guidances are published for the ASEAN country-group.

I have no experience with these guidances, so I won't venture to answer the question.

 

[LQ. Fanny Lozano]

Thank you anyway....but still the doubt stays about if I rather do or not an IFU format.

Hope that someone who already submitted medical devices on those countries could help!! Regards

 

[sreenu927]

Hi,

If you don't have any formal IFU or Product Insert, then you can paste the content as it is in the prescribed sections including the warnings, precautions, contraindications etc..
Else, you can put it as a word document and make it as a pdf and make as an appendix to cSDT, at section 4.2.2, "refer appendix X".
Either ways are accepted.

Regards,
Sreenu

 

[LQ. Fanny Lozano]

Thanks a lot Sreenu!! Now I don't have to worry in designing a formal IFU for my products which due to their nature they don't really need any...I think it is more like "electromedical" stuff and for complex medical devices.

Best regards and thanks for the information!!