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Medtech Guidance Tracker - December 2015

This article was originally published in SRA

Executive Summary

Click on the links to access the documents.

Country

Organization

Document

Status

Australia

TGA

Classification of IVD medical devices

Final

Australia

TGA

IMDRF Table of Contents pilot: TGA regional assembly and technical guide

Final

Canada

HC

Guidance Document - Fees for the Review of Medical Device Licence Applications

Final

EU

EUnetHTA

WP7-SG3 "Therapeutic medical devices" guideline

Final

EU

EMA

Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device (EMA/587433/2015)

Final

Malaysia

MDA

Draft Guidance Document On Licensing For Establishment

Draft

US

FDA

Unique Device Identification: Convenience Kits

Draft

US

FDA

Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals")

Draft

US

FDA

Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses

Draft

US

FDA

Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices

Final

US

FDA

eCopy Program for Medical Device Submissions

Final

US

FDA

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings

Final

Key

TGA: Therapeutic Goods Administration

HC: Health Canada

EUnetHTA: European network for health technology assessment

EMA: European Medicines Agency

MDA: Medical Device Authority

FDA: Food and Drug Authority

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