Registration Documentation
(ISO 13485 & MDSAP)

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Substantial Change QMS

General Conditions

Client Agreement

CE Marking

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)

Regulation (EU) 2017/745 IVDR

Regulation (EU) 2017/746 IVDR

Health Canada

At NSAI We Know Medical Devices - From CE Markings to MDSAP

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 Medical Device Manufacturing System Quality Management Certification from NSAI

ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.

Simply put, if you want to sell your product globally, you need to be ISO 13485 certified.

NSAI is a Notified Body that specializes in medical device certifications. We’re committed, responsive and ready to help your company achieve ISO 13485 certification. Our support team manages the various aspects of the certification process so that you don't have to, resulting in faster turn-around times, open communications and increased efficiency. In short, we deliver.

Let NSAI Help Your Company Achieve a CE Mark for Its Medical Device

If you want to sell your medical device in Europe you will need CE Marking on the product to show it complies with European health, safety and environmental protection legislation. If you’re looking for a partner to help you achieve a CE Marking, look no further than NSAI.

At NSAI, we’re experts in helping companies achieve CE marking for their products and stay compliant with Europe’s Medical Device Directive. We can start with a regulatory guidance before your CE Mark submission as well as confirmed scheduling of the technical file review.  We then provide conformity assessments, and ongoing surveillance activities to help your company maintain its conformity.

Medical Device Single Audit Program (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.

More information and documents about the International Medical Device Regulators Forum (IMDRF) and MDSAP are available on the IMDRF website and on the FDA’s website.  

The regulatory authorities that are currently participating in the MDSAP Pilot Program are:

How will regulatory authorities utilize MDSAP audit reports?

Australia:  The Therapeutics Goods Administration - TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

Brazil:  The Brazilian National Health Surveillance Agency – ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. 

Canada: Health Canada – HC accepts the results of the Medical Devices Single Audit Program as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.

Japan: MHLW and PMDA will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan. Undergoing the MDSAP Pilot audits is expected .to reduce some burden on Japanese regulatory processes.

United States:  U.S. Food and Drug Administration’s Center for Devices and Radiological Health – FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections.  Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program.  Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.”

Note: The European Union, China and Russia are members of the IMDRF Management Committee but are not participating in the pilot program at this time.

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