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Category Archives: Blog

Medfins International > Blog
15
Feb
Date February 15, 2024
Author Mr. Arunkumar Chokkalingam

NEW IVD

In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
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0 Comments Author Mr. Arunkumar Chokkalingam
24
Jan
Unique Device Identification
Date January 24, 2024
Author Mr. Arunkumar Chokkalingam

What is UDI in the EU Context?

Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
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0 Comments Author Mr. Arunkumar Chokkalingam
16
Nov
Introduction-to-Technical-Documentation-under-EU-MDR-2017745
Date November 16, 2023
Author Mr. Arunkumar Chokkalingam

Introduction to Technical Documentation under EU MDR 2017/745

Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
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0 Comments Author Mr. Arunkumar Chokkalingam
30
Oct
What is EUDAMED
Date October 30, 2023
Author Mr. Arunkumar Chokkalingam

What is EUDAMED

It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vi...
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0 Comments Author Mr. Arunkumar Chokkalingam
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