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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

At NSAI We Know Medical Devices - From CE Markings to CMDCAS and JPAL

NSAI is a leading Notified Body for medical device certification services. We have achieved this distinction by being the most responsive Notified Body in the market, giving our clients the level of service they deserve and require to get their products to market quicker. We offer a full range of Management System and Certification Standards for the medical device industry including:

ISO 13485

The global standard for comprehensive management system for the design and manufacture of medical devices. (read more)

CE MARKING

Want to sell your medical product in Europe? You’ll need a CE Marking from NSAI. (read more)

CMDCAS

The Canadian Medical Devices Conformity Assessment System is your ticket into the Canadian medical marketplace. (read more)

MDSAP

The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485 and their respective regulatory requirements. (read more)

If you’re looking to get your products on sale in more markets across the globe, contact NSAI today. We know medical devices!

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