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Medtech Guidance Tracker - October 2015

This article was originally published in SRA

Executive Summary

Click on the links to access the documents.

Country

Organization

Document

Status

International

IMDRF

Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations

Final

International

IMDRF

Medical Device Regulatory Audit Reports

Final

International

IMDRF

Software as a Medical Device (SaMD): Application of Quality Management System

Final

Australia

TGA

Draft: Uniform Recall Procedure for Therapeutic Goods

Draft

China

CFDA

Guideline for Medical Device Good Manufacturing Practice On-site Inspection

Final

China

CFDA

Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Sterile Medical Devices

Final

China

CFDA

Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Implantable Medical Devices

Final

China

CFDA

Guideline for Medical Device Good Manufacturing Practice On-site Inspection for In Vitro Diagnosis Reagents

Final

EU

EC

Guidelines for Competent Authorities for Making a Validation/Assessment of a Clinical Investigation Application under Directives 90/385/EEC and 93/42/EEC

Final

EU

EC

Manual on borderline and classification in the Community Regulatory framework for medical devices, version 1.17 (09-2015)

Final

EU

EUnetHTA

Therapeutic medical devices

Draft

EU

EUnetHTA

Endpoints used in Relative Effectiveness Assessment - Safety

Draft

Malaysia

MDA

Requirements for Labelling of Medical device

Draft

Malaysia

MDA

Good Distribution Practice for Medical devices (GDPMD), MDA/RR No 1: November 2015

Final

US

FDA

Manufacturing Site Change Supplements: Content and Submission

Draft

US

FDA

General Considerations for Animal Studies for Medical Devices

Draft

Key

IMDRF: International Medical Device Regulators Forum

TGA: Therapeutic Goods Administration

CFDA: China Food and Drug Administration

EC: European Commission

EUnetHTA: European Network for Health Technology Assessment

MDA: Medical Device Authority

FDA: Food and Drug Administration

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