Category: Medical Device

Categorization and Registration Process for Devices in EUDAMED

November 19, 2021
Medical Device

Categorization of Devices Categorization of devices to be registered in EUDAMED include: Regulation Devices – Regulation Devices are defined as medical devices and in vitro diagnostic...

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Guidance on Premarket Submission for Device Software Functions

November 12, 2021
Medical Device

The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software...

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Medical Devices – USA/Europe Regulatory Updates round up – Oct 2021

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

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Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

November 3, 2021
Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the PhilippinesThis Circular aims to: Specify the establishments classified as retailers...

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Switch of the legal status of a medicinal product from prescription to non-prescription – Romania

October 18, 2021
Medical Device

Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription to non-prescription – Romania Principles and procedures: • It is to the applicant to...

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Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

October 6, 2021
Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

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