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Registration Documentation
(ISO 13485 / CMDCAS & MDSAP)

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


TYVEK Application Form


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

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.

Interested in learning how NSAI can help your company become CMDCAS certified? Contact us today or fill out our RFQ form. One of our experts will get back to you within 24 hours – guaranteed.

When time is of the essence and customer service is what you need, choose the National Standards Authority of Ireland.

 

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