Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Medtech Guidance Tracker - January 2016

This article was originally published in SRA

Executive Summary

Click on the links to access the documents.

Country

 

Organization

 

Document

 

Status

 

International

 

AHWP

 

Regulation of Combination Products – a Review of International Practice

 

Final

 

International

 

AHWP

 

Guidance for Preparation of a Common Submission Dossier Template Dossier for General Medical Device Product Submission

 

Final

 

International

 

AHWP

 

Definition of the Terms "Medical Device" and "In Vitro Diagnostic (IVD) Medical Device"

 

Final

 

International

 

AHWP

 

Guidance Document on Qualification of Medical device Software

 

Final

 

International

 

AHWP

 

Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative

 

Final

 

International

 

AHWP

 

Clinical Evaluation

 

Final

 

International

 

AHWP

 

Clinical Evidence for Medical Device – Key Definitions and Concepts

 

Final

 

International

 

AHWP

 

Clinical Evidence for IVD Medical Device – Key Definitions and Concept

 

Final

 

International

 

AHWP

 

Clinical Evidence for IVD Medical Device – Scientific Validity Determination and Performance Evaluation

 

Final

 

International

 

AHWP

 

Distributor Auditing Checklist

 

Final

 

International

 

AHWP

 

Guidance on Regulatory Auditing of Quality Management System of Medical Device Distributors: Auditing Strategies

 

Final

 

International

 

AHWP

 

Regulatory Audit Report Guidance Document

 

Final

 

International

 

AHWP

 

Guidance for Medical Device Naming Rule

 

Final

 

EU

 

EUnetHTA

 

HTA Core Model: Guiding principles on use

 

Final

 

Germany

 

BfArM

 

Guidance on "Medical Apps"

 

Final

 

Malaysia

 

MDA

 

Declaration of Conformity (DOC)

 

Final

 

US

 

FDA

 

Postmarket Management of Cybersecurity in Medical Devices

 

Draft

 

US

 

FDA

 

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

 

Draft

 

US

 

FDA

 

List of Highest Priority Devices for Human Factors Review

 

Draft

 

US

 

FDA

 

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices

 

Draft

 

US

 

FDA

 

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

 

Final

 

US

 

FDA

 

Applying Human Factors and Usability Engineering to Medical Devices

 

Final

 

Advertisement
Advertisement
UsernamePublicRestriction

Register

MT040712

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel