Resource Documents by Month

December 2014

CDSCO’s Draft Guideline on Device GMPs

CDSCO’s Medical Device & Diagnostics Division Organogram

Canada’s Product Safety Law (Vanessa’s Law)

European Commission’s Opinion on Use of DEHP in Medical Devices

Health Technology Network’s Strategy for EU Cooperation on Technology Assessments

EUnetHTA’s Report on Methods for Health Economic Evaluations

EDMA’s Position Paper on HTA Network

NBOG’s Guidance on Reporting of Changes in Quality System and Design

NBOG’s Conformity Assessment Procedures and General Rules

NBOG’s Guidance on Personnel Involvement in Conformity Assessment Activities

IMDRF’s Final Report on Recognized International Standards

U.S. FDA’s Draft Order on Pedical Screws

Progressive Policy Institute’s Memo on FDA Regulation in the Data-Driven Economy

NICE’s Guidance on ReCell Spray-On Skin System

NICE’s Guidance on Parafricta Bootees and Undergarments

November 2014

IMDRF’s MDSAP Assessment Process for Third-Party Auditing Organizations

U.S. FDA’s Inspectorate Reorganization Plan

U.S. FDA’s Device Quality Systems Data

SCENIHR’s Opinion on Metal-on-Metal Joint Replacements

IMDRF’s Draft Document on National Competent Authority Report Exchanges

Canada’s Draft Guidance on Device Labeling

Canada’s Draft Guidance on Completing a Licensing Application Form

Canada’s Class II Device License Application Form

Canada’s Class II Amendment License Application Form

Australia’s Report on Innovation and Competitiveness

Australia’s Terms of Reference for Independent Review of Device Regulations

India’s Notice on Medical Device Labels

U.S. FDA’s Draft Guidance on Device Cybersecurity

IMDRF’s Framework for Categorizing Risk of Medical Device Software

U.S. FDA’s Final Guidance on Distinguishing Device Recalls From Enhancements

U.S. FDA’s Draft Guidance on a Framework for Regulatory Oversight of Laboratory-Developed Tests

U.S. FDA’s Draft Guidance on Medical Device Reporting for LDTs

CHI’s Report on U.S. Device Review Times

October 2014

NBRG’s Consensus Paper on Audits and Assessments Performed by Notified Bodies

European Commission Panel’s Opinion on Dental Amalgam and Alternative Materials

AHWP’s Guidance on Adverse Event Reporting Timelines

Japan’s Draft Amendment on Standard for Biological Ingredients

U.S. FDA’s Guidance on Dengue Virus Nucleic Acid Amplification Test Reagents

MHRA Proposal to Introduce a Fee for Certificates of Free Sale

Medical Technology Association of Australia’s Industry Code of Practice

September 2014

IMDRF’s Guidance on TOCs for Medical Device Regulatory Submissions

IMDRF’s Guidance on TOCs for In Vitro Diagnostic Regulatory Submissions

Anvisa’s Proposed Regulation on Clinical Trials

Anvisa’s Proposal to Expand Public-Private Development Partnerships

Flowchart on Anvisa’s Public-Private Development Partnerships

BMJ List of Questionable European Notified Bodies

U.S. FDA’s Draft Guideline on De Novo Classification Process

AusBiotech’s Comments on TGA Low Value Turnover Exemption Scheme

Comments Submitted on TGA Low Value Turnover Exemption Scheme

Market Research Report on Medical Technology: Vision 2025

U.S. FDA Guidance on Intent to Exempt Certain Devices from Premarket Notification

Health Canada’s List of Combination Products

August 2014

Stephenson Report on MHRA’s Access to Expert Advice on Medical Devices

MHRA’s Response to Stephenson Report on Access to Expert Advice

Notified Body Recommendation Group’s Consensus Paper on Risk Management Needed to Comply With EU’s MDD, Annexes Z

SCENIHR’s Guidance on Risk Evaluation of Nanomaterials

U.S. FDA’s Guidance on Risk-Benefit Considerations in 510(k)s Notifications

U.S. FDA’s Guidance on Evaluating Substantial Equivalence in 510(k) Notifications

U.S. Federal Register Notice on Evaluating Substantial Equivalence in 510(k) Notifications

Japan’s Technical Guidance on Development of Companion Diagnostics

Turkey’s Regulation on Sale, Advertisement and Promotion of Medical Devices

India’s Procedures for Review of Clinical Trial Applications

Team-NB’s Code of Conduct for Notified Bodies

July 2014

European Commission Staff Working Document on Implementation of the Joint Plan for Actions on Medical Devices

U.S. FDA Guidance on Global Unique Device Identification Database

Philippines FDA Administrative Order on Ethical Standards for Health Product Promotion

U.S. FDA Guidance on Risk/Benefit Information in Social Media Messages

U.S. FDA Guidance on Correcting Third-Party Information

Health Canada List of Recognized Standards

U.S. FDA/Customs and Border Protection Trusted Trade Pilot Program

U.S. FDA Strategic Priorities 2014-2018

UK MHRA Consultation on Revoking the Clinical Thermometer Regulation

U.S. FDA eSubmitter Software Update

Japan PMDA Guidance on Combination Diagnostics

Eucomed White Paper on Sustainable Funding of Medical Devices

India CDSCO Revised List of Regulated Medical Devices

India CDSCO Previous List of Regulated Medical Devices

June 2014

South Africa’s Draft Medical Device Regulation

Australia’s Amendment to IVD Regulation

Explanatory Note on Aussie IVD Amendment

Anvisa’s IVD Resolution, Portuguese

Anvisa’s Medical Device Resolution, in Portuguese

Malaysia’s Guideline on IVD Registrations, Submissions

Japan’s Requirements for Companion Diagnostics

Team-NB’s Survey of Notified Body Performance

MTAA’s White Paper on Regulatory Reform

TGA’s 2013 Report on Adverse Event Reporting

EUnetHTA’s Draft Guideline on Meta-Analysis of Diagnostic Test Accuracy Studies

AHWP’s White Paper on Software as a Medical Device

May 2014

Argentina’s Medical Products Traceability Scheme (in Spanish)

India’ Draft Rules on Clinical Trial Compensation

India’s Clinical Trial Injury Compensation Formula

U.S. FDA’s Expedited Access PMA Program

U.S. FDA’s Draft Guidance on Postmarket Studies

TGA’s Approach to Disclosure of Commercially Confidential Information

MHRA’s Report on Medical Device Adverse Incidents, 2011-2013

U.S. FDA’s Medical Device 2012 Quality System Data

National Institute for Health and Care Excellence’s Guidance on Heart Devices

Medical Technology Association of Australia’s Code of Practice

April 2014

TGA Draft Compositional Guideline for Molybdenum Trioxide

FDA Draft Guidance on Humanitarian Device Exemptions

AdvaMed MOU with Brazilian Counterparts on Ethical Business Practices

EU Regulation on Data Protection

MHRA Guidance on Software as Standalone Devices

NICE Proposal on Medtech Assessments

Russia’s Device Procurement List

IMDRF Guidance on Assessment of Auditing Organizations

Eucomed FAQ on RoHS 2 Directive

SCENIHR Opinion on New of Metal-on-Metal Implants

Eucomed Position Paper on EU Device Regulations

March 2014

U.S. FDA eMDR Guidance

Final Rule on MDR Electronic Submission Requirements

U.S. FDA Memo Detailing Agency Reorganization

U.S. FDA Final Guidance on Presubmission Program

Report on Modifications to U.S. 510(k) Process

U.S. FDA Draft Guidance on Annual Reports for Approved PMA Applications

MHRA Guidance on Borderline Devices

UK Summary of 2012 Adverse Event Reports

Industry Guidance on RoHS 2 Market Requirements

February 2014

CDSCO Guideline on Audio-Visual Consent

India’s Clinical Trial Compensation Formula

Peru’s Order on Importation of Unregistered Devices

U.S. FDA Final Rule on Pediatric Device Submissions

U.S. FDA Draft Guidance on Custom Device Exemptions

Eunethta Rapid Assessment of Renal Denervation

Summary of Comments on Eunethta Rapid Assessment

NICE Guidance on Implantable Cardioverter Defibrillators

Nice Guidance on Magnetic Migraine Device

COCIR Guideline on CT Energy Conservation

NICE Recommendation on Spinal Device

Ecuador’s Draft Regulation on External Limb Prostheses

January 2014

The Protecting Canadians From Unsafe Drugs Act, “Vanessa’s Law”

European Commission’s Notice of Evidence Needed for HTA Assessors

NICE’s Guidance on JOTEC’s E-vita Open Plus

IMDRF’s Final Guidance on UDIs

IMDRF’s Final Guidance on Key Definitions for SaMD

India’s Guidance on Registration/Reregistration of IVD Kits

India’s Guidance on Import of Notified Kits

India’s Guidance on Import of Non-Notified Kits

December 2013

Chaudhury Clinical Trial Reform Report

Indian Order Requiring Audio/Visual Consent for Trials

IMDRF’s Outcome Report

U.S. FDA Division of International Compliance Operations Organizational Chart

MHRA Sponsor Guidance

MHRA Biosafety Guidance

MHRA Statistical Requirement Guidance

MHRA Investigator Guidance

MHRA Clinical Assessor Guidance

U.S. FDA Draft Guidance for Device Development Tools

MTANZ’s Report ANZTPA – A Proposed Regulatory Agency

U.S. FDA Guidance on Blinding Medtech Trials

November 2013

List of Canadian Medical Devices Conformity Assessment System Registrars

EU Parliament’s Adopted Text of Medical Device Regulation

EU Parliament’s Approved Text for IVD Regulations

EU Data Protection Proposals with LIBE Committee’s Amendments

UK’s NICE Guidance on MoM Hip Replacements

EU Court of Justice Ruling on Borderline Products

SCENIHR’s Full Report on Breast Implants

U.S. FDA’s Final Guidance on Investigational Device Exemption Early Feasibility Studies

U.S. FDA’s Guidance on Device eCopy Submissions

Malaysia’s Draft Guidance on Installation, Testing and Commissioning of Medical Devices

EU’s SCHER Opinion on Effects Of Mercury From Dental Amalgams

Health Canada’s List of Recognized Device Standards

October 2013

European Commission’s Implementing Regulation on Criteria for Notified Bodies

European Commission’s Recommendation on Notified Body Audits and Assessments

Eucomed’s Cost Fact Sheet on Proposed Medical Device Regulations

U.S. FDA’s Final Rule on Unique Device Identification

India’s Drugs and Cosmetics (Amendment) Bill, 2013

U.S. FDA’s Final Guidance on Mobile Apps

TGA’s Q&A Guidance on Mobile Apps

Medsafe’s Proposal on Contraceptive Standards

UK Health Research Authority’s Transparency Mandate

September 2013

India’s Drugs and Cosmetics (Amendment) Bill, 2013

Ministry of Health and Family Welfare’s Trial Compensation Notice

Brazil’s Clean Company Act (In Portuguese)

Decree on New GMP Framework (In Portuguese)

EPHA’s Opinion Paper on EU Medical Device Regulations

Malaysia’s Guideline on Device Registration

List of Malaysian Conformity Assessment Bodies

U.S. FDA’s Guidance on Risk-Based Clinical Trial Monitoring

Medtronic’s Comments on TGA Premarket Assessment Requirements

BSI’s Comments on TGA Premarket Assessment Requirements

U.S. FDA’s Guidance on Wireless Radiofrequency Devices

U.S. FDA’s Guidance on New User Fees

NICE’s Guidance on Breast Cancer Post-Surgery Test

EMA, U.S. FDA Notice of Joint Orphan Product Meeting

August 2013

Rapporteur’s Opinion on EU Medical Device Regulations

Report on EU Notified Body Certificates

IMDRF Proposal on Standalone Software

TGA Consultation on IVD Regulation

IVD Australia Comments on IVD Consultation

Abbott Response to IVD Consultation

Alere Response to IVD Consultation

TGA Consultation on High-Risk Device Advertising

MTAA Response to High-Risk Device Advertising Proposal

EUnetHTA Renal Nerve Denervation Draft Pilot Plan

Responses to EUnetHTA’s RND Draft Pilot Plan

NICE Guidance on the Vision Amniotic Leak Detector

NICE Guidance on the Oking Ascope2

FDA Guidance on ISO-10993

Malaysia Guidance on Good Distribution Practice for Devices

Biotechnology Regulatory Authority of India Bill, 2013

CDSCO Draft Rules on Clinical Trial Compensation

India Draft Trial Compensation Guideline

July 2013

Eucomed Guidance on Conformity Assessment Requirements Under RoHS 2 and MDD

MHRA Report on Implementing Track-and-Trace for High-risk Devices

MTAA Comments on TGA’s Push for Tighter Device Premarket Controls

TGA Proposal on Special Labeling for New-to-Market Devices

U.S. Supreme Court Ruling on Patentability of Isolated DNA

U.S. FDA Consultation on Demasking Clinical and Preclinical Safety Data

Colombia Guideline for Device Importers (in Spanish)

June 2013

EU Reports and Amendments on the Medical Device and IVD Regulations

EC’s Overview of Comments on the ATMP Regulation

Eucomed’s Comments on the ATMP Regulation

National Services Scotland’s Comments on the ATMP Regulation

UK Consultation on Animal Tissue and eLabeling Regulations

EC’s Request for Scientific Opinion on Synthetic Biology

Australia’s Premarket Reform Proposals Impact Analysis

Australia Independent Hospital Pricing Authority’s Paper on Clinical Trial Costs

Australia Device Industry’s Response to IHPA Paper

Canadian Health Policy Institute’s Study on Device Spending

U.S. FDA’s Proposed Rule Notice on Foreign Data

U.S. Securities and Exchange Commission’s Final Rule on Conflict Minerals

Drug Controller General of India’s Appointment Order

May 2013

IMDRF’s UDI Scheme

EU’s UDI Recommendation

Rapporteur’s Report on EU Medical Device Regulation

Rapporteur’s Report on EU IVD Regulation

Trans-Tasman Warning System comments

Philippine’s FDA Postmarket Alert System Circular

Australian Government’s Draft Mobile Privacy Guide

MTTA’s Comments on Mobile Privacy Proposal

Aussie Device Associations’ Comments on Pharma Transparency Bill

U.S. Securities & Exchange Commission’s Conflict Minerals Disclosure Rule

Philippine FDA’s Revised Renewal Application Process

Brazil’s GMP Regulation

MHRA’s Corporate Plan

April 2013

Saudi Arabia’s Guidance for Grouping Device Authorization Documentation

MTAA’s Comments on Changes to Device Premarket Assessment Requirements

Argentina’s Device Registration Notice (in Spanish)

Health Canada’s Guidance on Classification of Products at the Drug-Device Interface

EU’s Late Payments Directive

Health Canada Revised List of Recognized Standards

March 2013

MPA Stand-Alone Software Guidance

TGA Progress Report

U.S. FDA Final Rule on Children in Clinical Trials

India’s Ethics Committee Registration Amendment

India’s Medical Device FAQ

India’s IVD FAQ

U.S. FDA Guidance: Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements

TGA Joint Reclassification Guideline

U.S. FDA Guidance: Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I

Malaysia’s Conformity Assessment Bodies Application

February 2013

Eucomed’s Position Paper on Proposed Revisions to the Medical Device Directives

COCIR’s Comments on the Proposed EU Medical Device Regulations

Federal Register Notice on Metal-on-Metal Hips

TGA Class III Implant Reclassification Checklist

TGA Premarket Scrutiny Proposals

EC’s Updated Guidance on Device Vigilance

Egypt’s Guideline on Medical Device Vigilance

NICE Guidance on WatchBP Home A Monitor

NICE Guidance on EXOGEN Bone-Healing System

European Commission Report on Modalities of Stakeholder Consultation in the Future Health Technology Assessment Network

Philippines’ Guideline on eCopy Submissions for Product, Facility Registrations

U.S. FDA Guidance on Acceptance and Filing Reviews for Premarket Approval Applications

U.S. FDA Guidance on 510(k) Refuse-to-Accept Policy

January 2013

UK Government Response on Proposed European Medical Device Regulations

Frequently Asked Questions on EU’s Unified Patent System

EC Consultation on New Regulation For Advanced Therapy Medical Products

FDA Seeks Comment On Independent Audits of CDRH’s Premarket Review Processes

Statement of Work for FDA on Independent Audits of Premarket Reviews

EU-New Zealand Mutual Agreement on Inspections, GMP

Singapore Draft Guidance on Quality System Requirements for Class A Devices