Design Philosophy - Iran Medical Device Registration

G

gathagmador

#1
Hello All,
I am completing a device registration for Iran and am stuck on one element the "Design Philosophy" The description of this in the registration info seems to be all over the place. Does anyone have an example of what this should look like they would kindly pass along?
 
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LFZR88

Involved In Discussions
#2
Re: "Design Philosophy" - Iran Medical Device Registration

Hi
I don't have any specific experience on this but I assume... ;) that they have taken this from the Canadian registrations which reads

(3)4.4 Design Philosophy

The features that enable the device to be used for the medical conditions and purposes for which it is manufactured, sold or represented by the manufacturer should be described. A brief description of the underlying science/technology, design concepts, and/or theoretical principles supporting the device's function should be provided, linking them to the claimed indications for use. References and comparisons with appropriate previous versions or generations of the device can be presented with reference to the previous version's Canadian medical device licence number. A tabular format is preferred for comparisons.

I don't know if this helps.... good luck
 

tibon74

Involved In Discussions
#3
Re: "Design Philosophy" - Iran Medical Device Registration

Hi !! could I have some details on the Iran regulation ?
Should we appoint a local representative? who is the license owner ? how much time it takes to approve a product? is there a renewal process ? if so, when ?
thank you !
 

LFZR88

Involved In Discussions
#6
Re: "Design Philosophy" - Iran Medical Device Registration

Hi All,
we have just found this application document for Iran with guidance notes, it contains info about the design philosophy that was asked back in August and other useful guidance.

Design Philosophy :
This section requests a description of the features that enable the device to be used for the medical conditions and purposes for which it is manufactured, sold or represented by the manufacturer. To satisfy this requirement, a brief description of the design philosophy and performance specifications for the device should be provided, linking them to the claimed indications for use. References and comparisons with appropriate previous versions or generations of the device should be presented. A tabular format is preferred for this comparison.
In the event that the use of the device is self-evident to the intended user, the customary or most frequent conditions or uses of the device should be summarized. This section should include an overview of the purposes and principles of operation for the device and a summary of the method of its use and operation, unless these instructions are not required for the
safe, effective use of the device. Details on the strength of materials and the accuracy, sensitivity and specificity of the device should also be supplied.
The physical aspects of the device, including packaging, operational capabilities and the processing of inputs and the resultant outputs, must be provided. This should include a summary comparison of the design input parameters (operation specifications) with the resultant performance specifications (design output characteristics).

hope this helps
Liz
 

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#8
Re: "Design Philosophy" - Iran Medical Device Registration

Dear all,

I have a query regarding registration of medical devoces in Iran.

The local representative : Does the local distributor become a sole distributor in Iran for the exporting company?

If yes, does the local authorised representative become for distributor product by product, or for the whole company?

If yes, for how long?

Thank you,
Best regards,
Primate
 
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