(ISO 13485 / CMDCAS & MDSAP)
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Apply For Registration
Substantial Change QMS
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
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)
Interested in CMDCAS? How about selling your product in Europe or Japan? Check out our CE Marking services.
CMDCAS: Canadian Medical Devices Conformity Assessment System from NSAI
So you want to sell your medical devices in Canada? NSAI is ready to help your company gain access to the Canadian Marketplace with CMDCAS certification. CMDCAS demonstrates that your company meets the Canadian QMS regulatory requirement for medical device licensing.
Don't have CMDCAS certification? Good news, you've come to the right place. At NSAI we're a Notified Body that knows medical devices and we're experts at delivering time-to-market certification services, with some of the fastest certification times in the industry. We help our clients get their products on the market faster, with less paperwork hassle.
When time is of the essence and customer service is what you need, choose the National Standards Authority of Ireland.