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Tag: TMDA

TMDA Guidance on Changes to Medical Devices: Application Process

The article describes in detail the application process to be followed concerning changes to legally marketed medical devices.  Table of Contents ...

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TMDA Guidance on Changes to Approved Medical Devices: Types of Changes

The new article provides additional details regarding the types of changes to medical devices, their features, and the regulatory approach to be applied.  ...

​​TMDA Guidance on Changes to Medical Devices: Overview

The article provides an overview of the regulatory requirements related to changes to medical devices already placed on the market.  Table...

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