Application Form


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NameApplication Form
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Medical Devices

Application Form


  • Class 2A

  • Class 2B Non-Implantable




New Application/ Transfer Submission Details


Please tick all that apply:



Class 2A









Class 2B Non-Implantable





















Transfer (from another NB)









Modular (partial application)





















Fast Track (expedited)










PO Number

     




Directive(s) that apply:

NSAI File Number



MDD (93/42/EEC)

252.     /     




Legal Manufacturer’s Name




Legal Manufacturer’s Address





INSTRUCTIONS


  1. Please complete all relevant sections of the form (excluding the NSAI Review sections).



  1. Please enter as much information onto the form as possible - avoid entering “see Technical File/Design Dossier”. If the data is in the supporting documentation, please ensure that there is a clear reference to the exact location of this information.



  1. Please submit an unsigned version of this Application in Word as well as a signed copy - either scanned/secured (pdf) copy.



  1. All application forms and supporting data to be forwarded in soft copy via one of the following (Hard copies not required)

NSAI upload facility : see http://www.nsaiinc.com/

  1. Supporting documents should be provided in a SEARCHABLE format



  1. Applications and supporting documentation must be in English



  1. Please send a representative sample of the device(s). This is particularly important for new/novel devices. Any video or animations of procedures/simulated use would also be helpful, if available.





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