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Registration Documentation
(ISO 13485 / CMDCAS)

Request For Quote

Apply For Registration

Substantial Change QMS

General Conditions

Client Agreement


CE Marking

Transfer Application

New Class 1 Application

Class 1 Substantial Change Application

New Class IIa & IIb Non Implantable Application

Class IIa & IIb Non Implantable Substantial Change Application

New Class IIb Implantable, Class III, AIMD Application

Class IIb Implantable, Class III, AIMD Substantial Change Application

All MDD/AIMD 3 Year Renewal Application

New IVD Application

IVD Substantial Change Application


IVD 3 Year Renewal Application


Vigilance Reporting


Post Market Surveillance Application


Equivalence Route


Medical Resource Links

Health Products Regulatory Authority


IDA Irish Development Agency

Medical Device Directive: (93/42/EEC)

Active Implantable (90/385/EEC)

In-Vitro Diagnostic (98/79/EC)

Health Canada

CE MARKING UPLOAD

Please create an ARCHIVE file (ZIP) of the required documents, attach and
*upload ZIP file below.

Create a ZIP file containing the following documents:

1) Word version of the completed Application or Change Notification form
2) PDF version of the completed Application or Change Notification form (to include signature)
3) All supporting documents required by the relevant Application/Change Notification form
• Please send attachments seperately rather than one large pdf file.
• Please label the attachments with their content.
• In 'Message' field below, please put Company name and File number as applicable.

If you are having difficulty uploading files then please try these steps:

 

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