International Medical Device Regulatory Monitor Documents Index
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Canada’s Draft Guidance on Device Labeling
Canada’s Draft Guidance on Completing a Licensing Application Form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U.S. FDA’s Draft Guidance on Device Cybersecurity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U.S. FDA’s Draft Guidance on a Framework for Regulatory Oversight of Laboratory-Developed Tests
U.S. FDA’s Draft Guidance on Medical Device Reporting for LDTs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
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
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
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
U.S. FDA Division of International Compliance Operations Organizational Chart
MHRA Statistical Requirement 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
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
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
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
Health Canada Revised List of Recognized Standards
March 2013
MPA Stand-Alone Software Guidance
U.S. FDA Final Rule on Children in Clinical Trials
India’s Ethics Committee Registration Amendment
TGA Joint Reclassification Guideline
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
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