Blog Archive: MedTech Industry

MDSAP: The Ultimate Guide to the Medical Device Single Audit Program

The MDSAP was designed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. A report from a single MDSAP audit is an accepted substitute for routine inspections by all the member Regulatory Authorities across the world.

FDA 510(k): A Beginners Guide

eBook excerpt - Congratulations! You have successfully developed a new medical device. Now you need to take it to market. In the United States, this often means submitting a 510(k). A 510(k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration (FDA).

EUDAMED and UDI in Europe: An Overview

The European Databank on Medical Devices (EUDAMED) is an IT system developed by the European Commission to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the European Union.

Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?

Marketing medical devices in the European Economic Area (EEA) can be a challenge. Some regulatory activities require interactions with regional level authorities, while others are handled by Member States. This article explains the different regulatory bodies that oversee medtech products within the European region.

Quick Reference Guide: Global Medical Device UDI Requirements and Timelines

Keeping track of country-specific UDI requirements, implementation timelines, and affected devices can be a big challenge to RA teams—especially because information is scattered across many sources. This guide consolidates timeline information and device class requirements across multiple regions.

The Ultimate Guide to the China NMPA UDI System and Database

eBook excerpt - In 2019, Chinese medical device regulations added a provision that devices carry a unique device identification (UDI). China's UDI requirements are similar to those in the US and EU. They establish specific device ID and labeling requirements, as well as a central, state-administered device database.