Pre-market Information - Class III and IV

Size: px
Start display at page:

Download "Pre-market Information - Class III and IV"

Transcription

1 Pre-market Information - Class III and IV Life Sciences Council British Columbia NRC Industry Research Assistance Program Vancouver, October 29, 2007 Mary-Jane Bell, Ph.D. Medical Devices Bureau (MDB) Therapeutic Products Directorate (TPD)

2 Overview Safety and Effectiveness Requirements Premarket Review Document Class III Class IV Special Cases

3 Licensed Medical Devices Medical devices licensed under Part 1 of the Medical Devices Regulations (MDR) represent the vast majority of medical devices sold in Canada. All these medical devices must meet the safety and effectiveness requirements set out in Sections 10 to 20

4 Manufacturer Obligations Licensed Devices Part 1 of the MDR detail the obligations and responsibilities of manufacturers and importers of medical devices who sell medical devices in Canada. These are inclusive of premarket, postmarket and quality systems responsibilities.

5 Medical Device Licence Applications Class III and IV As part of the medical device licence application for Class III and IV devices some evidence supporting safety and effectiveness is required. More premarket evidence is required for a Class IV device, relative to a Class III medical device.

6 PREMARKET REVIEW DOCUMENTS Required for Class III and IV medical devices. The premarket review document contains the objective evidence required to determine if the device licence application or amended device licence application meets the safety and effectiveness requirements of the Regulations. A guidance document prescribes the format and content of this file.

7 Medical Device Licence Applications In order to obtain a medical device licence, a manufacturer is required to submit information to Health Canada to demonstrate that the medical device in question is safe and effective. The safety and effectiveness information provided by each manufacturer is confidential and proprietary to their own product. It cannot be used to support products manufactured by another entity. Information from the peer-reviewed, publicly available scientific literature can be used as appropriate to support the safety and effectiveness of any medical device.

8 Class III Premarket Review Document Background Information: Device description, including design philosophy Marketing history Safety and Effectiveness List of standards, declaration of conformity Summary of all studies relied upon Validation procedures and results Labelling

9 Background Information Device Description - general description of the device and the materials used in its construction and packaging. Principles of design - description of the features, including performance specifications of the device that permit it to be used for its intended purposes. Marketing History - information on regulatory status, problem reports, recalls and known sales volumes in major world markets.

10 Safety and Effectiveness (1) List of Standards Manufacturers are requested to supply a list of standards complied with during the design and manufacture of the device to satisfy the safety and effectiveness requirements. A declaration of conformity in accordance with the Standards Policy can be provided for MDB recognized standards, to minimize the data reporting requirements.

11 Safety and Effectiveness (2) Summary of studies relied on to ensure the medical device meets the safety and effectiveness requirements: Is dependent upon the device in question, might include biocompatibility, electrical safety, mechanical strength and potential clinical evidence of effectiveness. Must include sufficient detail as to how the testing was conducted, the results obtained and most importantly the conclusions drawn by the manufacturer. Bibliography specific to the device in question.

12 Safety and Effectiveness (3) Validation processes and results to establish the safety and effectiveness of the device. Including but not limited to: Sterilization validation Software design validation Calibration processes, etc.

13 Labelling Labelling must comply with Sections 21 to 23 of the MDR. Label is defined in the Food and Drugs Act and includes any legend, word or mark attached to, included in, belonging to or accompanying a device or package. Labelling claims must be supported by the evidence of safety and effectiveness supplied.

14 LABELLING (2) The final labelling text must be submitted for review, including: inner and outer labels; package inserts; product brochures; and, information and instructions for use. There are two labelling guidance documents available from TPD, one for general medical devices the other for in Vitro diagnostic devices.

15 Class IV Premarket Review Document The following are the same as a Class III application: Background Information: Device description, including design philosophy Marketing history Safety and Effectiveness List of standards Validation procedures and results Labelling Summary of studies is replaced with specific device requirements.

16 Class IV Premarket Review Document The safety and effectiveness of Class IV medical devices must be supported by the following: Manufacturing and quality control processes and procedures, including a quality plan; Risk assessment; Complete material specifications; Preclinical test methods, results, analysis and conclusions, and; Clinical results, including protocols, results, analysis and conclusions.

17 Manufacturing Information Manufacturing methods Quality plan, or outline of manufacturing processes including key checkpoints Packaging methods and materials Sterilization methods, including validation Supported by a valid certificate of compliance to CAN/ISO

18 Material Characterization Identification of all component materials by name and % of final product. Bulk properties, raw material acceptance criteria Mechanical, physical and chemical properties of finished products Identification of catalysts, cross-linkers or terminating species

19 Risk Assessment The Regulations require manufacturers prepare a risk assessment including: an analysis and evaluation of risk Risk reduction methods employed A risk assessment should compare the results of using a device with alternate or no treatment options.

20 Preclinical Testing The type of preclinical testing required is dependent upon the device in question, but may include: Mechanical and Physical Testing Biocompatibility, including toxicity Degradation studies to determine device longevity Complete methods, results, analysis and conclusions should be presented.

21 Clinical Evidence Evidence of effectiveness can be demonstrated in a number of ways, each with its own strengths and weaknesses. Prospective clinical trial. Retrospective review of clinical data. Clinical review of the literature, relevant to the device in question with analysis and conclusions presented.

22 Special Cases (1) Medical devices containing biological materials. Specific policies and guidance documents available addressing the risks of transmissible disease. Use of bovine, caprine and ovine materials only from countries certified as BSE free by CFIA. Donor selection issues and viral validation processes are carefully reviewed for devices containing human materials.

23 Special Cases (2) Combination products regulated as medical devices. Currently developing and/or updating policies and procedures in this area. These medical device licence applications may involve a review team, and may take longer to finalize.

24 Special Cases (3) Near patient in vitro diagnostic devices, which by definition are used outside of a laboratory setting. These medical device licence applications must be supported by prospective clinical data conducted with the intended user population, and under conditions of use similar to those claimed.

25 Health Canada s Review Process Are these tests sufficient to establish that the device will not adversely affect the health or safety of a patient? OR Is a possible adverse effect, an acceptable risk when weighed against the benefits to the patient?

26 Health Canada s Review Process (2) Are additional tests required to establish safety? Are additional warnings and precautions required for any remaining risks? Should risk be determined based on finished product testing or raw material characteristics? Or both?

27 Review Outcomes There are three (3) potential review outcomes: Licence Licence with conditions Refuse to licence

28 Post Licensing Requirements Compliance with any licensing conditions. Mandatory problem reporting. Complaint handling, distribution records and recalls. Implant registration (if applicable). Obligation to inform, or licence renewal. Apply for medical device licence amendments as appropriate.

Investigational Testing Requirements

Investigational Testing Requirements Investigational Testing Requirements Life Sciences Council British Columbia NRC Industry Research Assistance Program Vancouver, October 29, 2007 Mary-Jane Bell, Ph.D. Medical Devices Bureau (MDB) Therapeutic

More information

How medical devices are approved in Canada

How medical devices are approved in Canada How medical devices are approved in Canada In Canada, the system of approval for medical devices is governed by the Medical Device Regulations of the Department of Justice (http://laws.justice.gc.ca/eng/sor-98-282/20091229/).

More information

MEDICAL DEVICE LICENSING REQUIREMENTS Life Sciences British Columbia NRC-Industry Research Assistance Program

MEDICAL DEVICE LICENSING REQUIREMENTS Life Sciences British Columbia NRC-Industry Research Assistance Program MEDICAL DEVICE LICENSING REQUIREMENTS Life Sciences British Columbia NRC-Industry Research Assistance Program Health Canada Regulations on Medical Devices Vancouver, B.C. October 29, 2007 Nancy Shadeed

More information

Presented by Rosemarie Bell 24 April 2014

Presented by Rosemarie Bell 24 April 2014 Global Good Manufacturing Practice A Comparability Study to Link Good Manufacturing Practice Standards for World Wide Compliance Within the Cellular Therapy Industry Presented by Rosemarie Bell 24 April

More information

Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994

Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical SUR-G0014-1 12 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations

More information

Overview of FDA Compliance for Medical Devices

Overview of FDA Compliance for Medical Devices Glisland Training Series: Overview of FDA Compliance for Medical Devices Glisland, Inc. San Jose, California, USA http://www.glisland.com Description This course provides a concise overview of how FDA

More information

Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca

Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca Software Regulated as a Medical Device Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca Therapeutic Products Directorate Director General S. Sharma

More information

AUSTRALIAN MEDICAL DEVICES GUIDELINES

AUSTRALIAN MEDICAL DEVICES GUIDELINES AUSTRALIAN MEDICAL DEVICES GUIDELINES Transitional Arrangements for the Introduction of the New Medical Devices Regulatory System Guidance Document Number 9 Version 1.6 DISCLAIMER This document is provided

More information

APPLICATION FOR A MEDICAL DEVICE REGISTRATION

APPLICATION FOR A MEDICAL DEVICE REGISTRATION ISLAMIC REPUBLIC OF IRAN MINISTRY OF HEALTH AND MEDICAL EDUCATION MEDICAL EQUIPMENT QUALITY AND PRICE REGULATORY DEPARTMENT APPLICATION FOR A MEDICAL DEVICE REGISTRATION Device Registration Number (Official

More information

FDA Regulation of Medical Devices

FDA Regulation of Medical Devices FDA Regulation of Medical Devices Bradley Merrill Thompson Interpharm Press, Inc. Buffalo Grove, IL Dedication Acknowledgments Introduction xv xvi xvii Part I. Overview Chapter 1. The History of Medical

More information

GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES

GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered

More information

Veterinary Compounding

Veterinary Compounding Veterinary Compounding Veterinarians occasionally use compounded preparations to meet a specific patient s medical need. The purpose of this brochure, created jointly by the Animal Health Institute (AHI),

More information

Medical Device Regulatory Requirements for Mexico

Medical Device Regulatory Requirements for Mexico Medical Device Regulatory Requirements for Mexico Updated: June 2011 Disclaimer: The information contained in this profile is derived from public sources, is intended to assist U.S. exporters in performing

More information

Annex 7 Guidelines on pre-approval inspections

Annex 7 Guidelines on pre-approval inspections World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the

More information

Cosmetic products in China

Cosmetic products in China Cosmetic products in China Imported cosmetics need pre-market approval before entering China All cosmetics imported into China are required to obtain pre-market approval or notification from the Chinese

More information

In vitro Device Regulation

In vitro Device Regulation In vitro Device Regulation Molecular Pathologists Reagent (Analyte) Manufacturers High Complexity Clinical Labs Commercial Academic in Vitro Diagnostics Manufacturers Drug Developers large & small 2 States

More information

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation

More information

Guidance for Industry Time and Extent Applications for Nonprescription Drug Products

Guidance for Industry Time and Extent Applications for Nonprescription Drug Products Guidance for Industry Time and Extent Applications for Nonprescription Drug Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

Device Registration Pathways in Canada

Device Registration Pathways in Canada Device Registration Pathways in Canada By Nancy Ruth, RAC, CQA (ASQ) 32 In Canada, medical devices are regulated by Health Canada s Therapeutic Products Directorate and are subject to the Canadian Medical

More information

Health Technology Regulations

Health Technology Regulations Objective: Safety of medical devices Health Technology Regulations Will replace Group III products in the Hazardous Substances Act of 1973 Safety for patient and operator: Manufacture Utilisation Maintenance

More information

MEDICAL DEVICES INTERIM REGULATION

MEDICAL DEVICES INTERIM REGULATION Issued by the Saudi Food and Drug Authority Board of Directors decree number 1-8-1429 and dated 27 December 2008 The Interim was published in Umm Al-QURA Journal year 86 Issue No:4249 dated in 17 April

More information

GUIDANCE ON LABELLING REQUIREMENTS FOR MEDICAL DEVICES

GUIDANCE ON LABELLING REQUIREMENTS FOR MEDICAL DEVICES MDS G10 GUIDANCE ON LABELLING REQUIREMENTS FOR MEDICAL DEVICES Version Number :1.0 Version Date: 18/01/2015 Page 1 of 20 TABLE OF CONTENT DEFINITIONS & ABBREVIATIONS... 3 Definitions... 3 Abbreviations...

More information

GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES

GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES Foreword This guidance document is informative and advisory and has no legal authority. Individual national enforcement authorities are bound

More information

Med-Info. Introduction to Korean Medical Device regulations. TÜV SÜD Product Service GmbH

Med-Info. Introduction to Korean Medical Device regulations. TÜV SÜD Product Service GmbH Med-Info International expert information for the Medical Device industry Introduction to Korean Medical Device regulations The Ministry of Health and Welfare (MHW) is the healthcare agency having overall

More information

MEDICAL DEVICE GUIDANCE

MEDICAL DEVICE GUIDANCE May 2014 MEDICAL DEVICE GUIDANCE GN-23: Guidance on Labelling for Medical Devices PREFACE This document is intended to provide general guidance. Although we have tried to ensure that the information contained

More information

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC August 2013 Contents 1 Introduction...3 2 Scope of the directive...3 2.1 What is an in vitro diagnostic medical device?... 3 2.2 Specimen

More information

Importing pharmaceutical products to China

Importing pharmaceutical products to China Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval

More information

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing

More information

US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines

US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines Norman W. Baylor Biologics Consulting Group, Inc. 23-25 June 2014 Foundation Merieux Conference Center OUTLINE OF PRESENTATION Introduction

More information

Page 191 TITLE 21 FOOD AND DRUGS 355 1

Page 191 TITLE 21 FOOD AND DRUGS 355 1 Page 191 TITLE 21 FOOD AND DRUGS 355 1 APPEALS TAKEN PRIOR TO OCTOBER 10, 1962 Section 104(d)(3) of Pub. L. 87 781 made amendments to subsec. (h) of this section inapplicable to any appeal taken prior

More information

Overview of Drug Development: the Regulatory Process

Overview of Drug Development: the Regulatory Process Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger

More information

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

IVD Regulation Overview. Requirements to Assure Quality & Effectiveness

IVD Regulation Overview. Requirements to Assure Quality & Effectiveness IVD Regulation Overview Requirements to Assure Quality & Effectiveness CLIAC Jan. 2002 Statutory and Regulatory Requirements Statute: Food, Drug, and Cosmetic Act Food and Drugs Act of 1906 Food and Drug

More information

Once a new drug is discovered, there is a specific series of steps it must go through to acquire FDA approval. Before any applications are sent to the

Once a new drug is discovered, there is a specific series of steps it must go through to acquire FDA approval. Before any applications are sent to the Research Primer: Introduction to the FDA Drug Approval Process and Off Label Use BRITTANY LA COUTURE OCTOBER 22, 2015 Introduction The United States is home to the majority of the world s new drug developers.

More information

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient

More information

Health Products and Food Branch. www.hc-sc.gc.ca

Health Products and Food Branch. www.hc-sc.gc.ca Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration

More information

Update: Proposed Medical Device Regulation (MDR) & IVD Regulation (IVDR)

Update: Proposed Medical Device Regulation (MDR) & IVD Regulation (IVDR) Update: Proposed Medical Device Regulation (MDR) & IVD Regulation (IVDR) Paul Brooks Healthcare Solutions Disclaimer The new regulations are not finalized and subject to change http://medicaldevices.bsigroup.com/en-us/resources/whitepapers-and-articles/

More information

Ethiopian Food, Medicine and Healthcare Administration and Control Authority. Medical Equipment Donation Directive

Ethiopian Food, Medicine and Healthcare Administration and Control Authority. Medical Equipment Donation Directive Ethiopian Food, Medicine and Healthcare Administration and Control Authority Medical Equipment Donation Directive December 2012 Addis Ababa I Contents Contents... II Part One... 1 General... 1 1. Short

More information

MEDICAL DEVICE GUIDANCE

MEDICAL DEVICE GUIDANCE May 2014 MEDICAL DEVICE GUIDANCE GN-21: Guidance on Change Notification for Registered Medical Devices Revision 3.1 PREFACE R3.1 This document is intended to provide general guidance. Although we have

More information

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof; DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of

More information

Medical Device Regulatory Requirements for Taiwan

Medical Device Regulatory Requirements for Taiwan Medical Device Regulatory Requirements for Taiwan Disclaimer: The information contained on this website is derived from public sources and is current to the best of the knowledge of the Department of Commerce

More information

The Medical Device Industry in Korea: Strategies for Market Entry

The Medical Device Industry in Korea: Strategies for Market Entry The Industry in Korea: Strategies Seth J. Goldenberg, Senior Principal Scientist, NAMSA; Yongha Na, Director, Medipert Regulatory NAMSA Whitepaper #09 06/2014 Seth J. Goldenberg, PhD (sgoldenberg@namsa.com)

More information

Simpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC V6i 3Y9. haroldbergmanl~ogmail.com 604 736 9890 Telephone 604 736 9747 Fax K080115

Simpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC V6i 3Y9. haroldbergmanl~ogmail.com 604 736 9890 Telephone 604 736 9747 Fax K080115 APR 5 2013 Summary: K121281 Submitter: Company Address Contact Person: Simpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC V6i 3Y9 Dr. Harold Bergman haroldbergmanl~ogmail.com 604 736 9890 Telephone

More information

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda

More information

The Regulation of Medical Devices in the UK

The Regulation of Medical Devices in the UK The Regulation of Medical Devices in the UK 1. What are the main requirements for a medical device to enter into the market and how are they regulated? Are there any licensing, marketing authorisation,

More information

GUIDELINES ON MEDICAL DEVICES EVALUATION OF CLINICAL DATA : A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

GUIDELINES ON MEDICAL DEVICES EVALUATION OF CLINICAL DATA : A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology MEDDEV. 2.7.1 April 2003 GUIDELINES

More information

MEDICAL DEVICES SECTOR

MEDICAL DEVICES SECTOR MEDICAL DEVICES SECTOR MDS - G1 GUIDANCE FOR MEDICAL DEVICE IMPORTERS Version 2 Our mission is to ensure the safety of food; the safety, quality and efficacy of drugs; and the safety and effectiveness

More information

Life Science Application Medical Device Liability

Life Science Application Medical Device Liability Life Science Application Medical Device Liability This is an application for a CLAIMS MADE POLICY. Should this application be accepted by the Company, coverage will apply to claims first made against the

More information

GUIDELINES ON MEDICAL DEVICES

GUIDELINES ON MEDICAL DEVICES EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health technology and Cosmetics MEDDEV 2.12/2 rev2 January 2012 GUIDELINES ON MEDICAL DEVICES POST MARKET CLINICAL FOLLOW-UP

More information

Diagnostic Tests. Brad Spring Director, Regulatory Affairs

Diagnostic Tests. Brad Spring Director, Regulatory Affairs Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market

More information

RAC (Global) Examination Study Checklist

RAC (Global) Examination Study Checklist RAC (Global) Examination Study Checklist Instructions: Use this checklist to track your progress when preparing for the RAC (Global) certification examination. When you begin your studying, each task statement

More information

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC Vigilance Reporting for Medical Devices in the EU By Salma Michor, PhD, RAC 24 September 2009 Manufacturers putting medical devices on the market in the European Union (EU) must have a vigilance system

More information

Frequently Asked Questions. Unannounced audits for manufacturers of CE-marked medical devices. 720 DM 0701-53a Rev 1 2014/10/02

Frequently Asked Questions. Unannounced audits for manufacturers of CE-marked medical devices. 720 DM 0701-53a Rev 1 2014/10/02 Frequently Asked Questions Unannounced audits for manufacturers of CE-marked medical devices 720 DM 0701-53a Rev 1 2014/10/02 What is an unannounced audit?... 6 Are unannounced audits part of a new requirement?...

More information

END CRUEL COSMETICS BILL 2014

END CRUEL COSMETICS BILL 2014 2013 2014 THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA THE SENATE END CRUEL COSMETICS BILL 2014 EXPLANATORY MEMORANDUM (Circulated by the authority of Senator Rhiannon) End Cruel Cosmetics Bill 2014

More information

NOTICE. Re: GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

NOTICE. Re: GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars February 8, 2007 NOTICE Our file number: 07-103218-349 Re: Performed by Health Canada Recognized Registrars Health Canada is pleased to announce the release of the revised guidance document GD210: ISO

More information

History and Principles of Good Clinical Practice

History and Principles of Good Clinical Practice History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices

More information

AUSTRALIAN MEDICAL DEVICES GUIDELINES

AUSTRALIAN MEDICAL DEVICES GUIDELINES AUSTRALIAN MEDICAL DEVICES GUIDELINES Obligations and Responsibilities of Medical Device Sponsors and Manufacturers Guidance Document Number 20 Version 1.6 DISCLAIMER This document is provided for guidance

More information

Changes to Medical Device Regulations

Changes to Medical Device Regulations Changes to Medical Device Regulations How these will affect distributors? IMSTA Breakfast Briefing, 24 October 2013 Niall MacAleenan Medical Device Lead, IMB. Slide 1 Content Revision of the medical device

More information

Standards of Practice for Pharmacists and Pharmacy Technicians

Standards of Practice for Pharmacists and Pharmacy Technicians Standards of Practice for Pharmacists and Pharmacy Technicians Introduction These standards are made under the authority of Section 133 of the Health Professions Act. They are one component of the law

More information

FDA Regulation of Hearing Aids. Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic and ENT Devices ODE/CDRH/FDA

FDA Regulation of Hearing Aids. Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic and ENT Devices ODE/CDRH/FDA FDA Regulation of Hearing Aids Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic ENT ODE/CDRH/FDA U.S. Food Drug Administration Presentation Outline Overview of device regulations riskbased

More information

GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES

GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES Foreword GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES These guidance notes do not aim to be a definite interpretation of National Laws and/or regulations and are for guidance purpose only.

More information

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 12. Special Issues Q&A Session. Michael Maier michael.maier@medidee.com www.medidee.

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 12. Special Issues Q&A Session. Michael Maier michael.maier@medidee.com www.medidee. Nano-Tera.ch 05 February 2015 part 12 Special Issues Q&A Session Michael Maier michael.maier@medidee.com www.medidee.com Questions you asked 1/17 In WHICH cases to seek approval 1 - Please provide us with

More information

Medical Software Development. International standards requirements and practice

Medical Software Development. International standards requirements and practice Medical Software Development International standards requirements and practice Food and Drug Administration What? A public health agency Why? Protect American consumers How? By enforcing the Federal Food,

More information

Medical Device Software

Medical Device Software Medical Device Software Bakul Patel Senior Policy Advisor 1 Overview Medical devices and software Oversight principles and Current approach Trends, Challenges and opportunities Addressing challenges 2

More information

CANADIAN RULE BASED CLASSIFICATION SYSTEM (IVDD) Life Sciences British Columbia NRC-Industry Research Assistance Program

CANADIAN RULE BASED CLASSIFICATION SYSTEM (IVDD) Life Sciences British Columbia NRC-Industry Research Assistance Program CANADIAN RULE BASED CLASSIFICATION SYSTEM (IVDD) Life Sciences British Columbia NRC-Industry Research Assistance Program Health Canada Regulations on Medical Devices Vancouver, B.C. October 29, 2007 Nancy

More information

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Document issued on: June 2004 U.S. Department of Health and Human Services Food and Drug Administration

More information

Regulatory Submission: Applying GLP in Surgical Efficacy Studies

Regulatory Submission: Applying GLP in Surgical Efficacy Studies Regulatory Submission: Applying GLP in Surgical Efficacy Studies Curtis Schondelmeyer, DVM Director Preclinical Veterinary Services and Efficacy and Surgical Research Services Welcome to Toxikon 2 CONFIDENTIAL

More information

Bayer HealthCare s Comprehensive Compliance Program Pursuant to California Health and Safety Code 119400-119402

Bayer HealthCare s Comprehensive Compliance Program Pursuant to California Health and Safety Code 119400-119402 Bayer HealthCare s Comprehensive Compliance Program Pursuant to California Health and Safety Code 119400-119402 I. INTRODUCTION Bayer HealthCare LLC [including Bayer HealthCare LLC Dermatology Division

More information

CTC Technology Readiness Levels

CTC Technology Readiness Levels CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.

More information

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013)

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) January 2013 RESTRICTED PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) DRAFT FOR COMMENTS Please address any comments on this proposal

More information

New Investigator Collaborations and Interactions: Regulatory

New Investigator Collaborations and Interactions: Regulatory Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials

More information

Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Humanitarian Device Exemptions

Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Humanitarian Device Exemptions FDLI s Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry October 28-29, 2002 The Westin Grand Hotel Washington, D.C. Premarket Approval Applications

More information

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them IRB Education Conference, Columbia University April 2007 Sally Hojvat, Ph.D. Director of Microbiology Devices

More information

Securities Act BC INSTRUMENT 22-502 REGISTRATION BY THE INVESTMENT INDUSTRY REGULATORY ORGANIZATION OF CANADA

Securities Act BC INSTRUMENT 22-502 REGISTRATION BY THE INVESTMENT INDUSTRY REGULATORY ORGANIZATION OF CANADA Securities Act BC INSTRUMENT 22-502 REGISTRATION BY THE INVESTMENT INDUSTRY REGULATORY ORGANIZATION OF CANADA Contents 1 Interpretation 2 Delegation of powers and duties of the Executive Director 3 Application

More information

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address: NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a

More information

FINAL DOCUMENT. Global Harmonization Task Force. Title: Label and Instructions for Use for Medical Devices

FINAL DOCUMENT. Global Harmonization Task Force. Title: Label and Instructions for Use for Medical Devices GHTF/SG1/N70:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Label and Instructions for Use for Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Task Force Endorsed

More information

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations Page 1 of 7 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2014 Inspections, Compliance, Enforcement, and Criminal Investigations

More information

247 CMR: BOARD OF REGISTRATION IN PHARMACY

247 CMR: BOARD OF REGISTRATION IN PHARMACY 247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPART- MENTS Section 9.01: Code of Professional Conduct for Registered Pharmacists,

More information

4.1 Objectives of Clinical Trial Assessment

4.1 Objectives of Clinical Trial Assessment L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical

More information

Glossary of Clinical Trial Terms

Glossary of Clinical Trial Terms Glossary of Clinical Trial Terms ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

FDA Basics For Biotech Drugs, Biologics and Devices

FDA Basics For Biotech Drugs, Biologics and Devices FDA Basics For Biotech Drugs, Biologics and Devices I. FDA Overview A. FDA has authority over products intended for the diagnosis, treatment or mitigation of human disease or intended to affect a structure

More information

Med-Info. Council Directive 93/42/EEC on Medical Devices. TÜV SÜD Product Service GmbH

Med-Info. Council Directive 93/42/EEC on Medical Devices. TÜV SÜD Product Service GmbH Med-Info International expert information for the Medical Device industry Council Directive 93/42/E on Medical Devices Practice-oriented summary of the most important aspects and requirements contained

More information

Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products EUROPEAN COMMISSION DG HEALTH & CONSUMERS Directorate B - Consumer Affairs Unit B2 Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.2/4 January 2012 Guidelines for conformity

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

FDA Evaluation of Point of Care Blood Glucose Meters

FDA Evaluation of Point of Care Blood Glucose Meters FDA Evaluation of Point of Care Blood Glucose Meters Denise N. Johnson-Lyles, Ph.D., Scientific Reviewer Office of in Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

More information

U.S. Food and Drug Administration (FDA) Regulatory Pathways for Medical Devices

U.S. Food and Drug Administration (FDA) Regulatory Pathways for Medical Devices Lisa L. Michels General Counsel & Regulatory Expert Susan J. Schniepp, Distinguished Fellow Regulatory Compliance Associates Inc. U.S. Food and Drug Administration (FDA) Regulatory Pathways for Medical

More information

Health Professions Act BYLAWS SCHEDULE F. PART 2 Hospital Pharmacy Standards of Practice. Table of Contents

Health Professions Act BYLAWS SCHEDULE F. PART 2 Hospital Pharmacy Standards of Practice. Table of Contents Health Professions Act BYLAWS SCHEDULE F PART 2 Hospital Pharmacy Standards of Practice Table of Contents 1. Application 2. Definitions 3. Drug Distribution 4. Drug Label 5. Returned Drugs 6. Drug Transfer

More information

Frequently Asked Questions (FAQ) About Patient Management Software Licensing

Frequently Asked Questions (FAQ) About Patient Management Software Licensing Frequently Asked Questions (FAQ) About Patient Management Software Licensing V1.0 April 12, 2010 About ITAC The Information Technology Association of Canada (ITAC) is the voice of the Canadian information

More information

5. 16. Health Law in Canada. Constitutional Division of Power

5. 16. Health Law in Canada. Constitutional Division of Power Health Law in Canada Health care in Canada is a complex subject, some health care services are public, some are private and there are a number of different entities involved in regulating and providing

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18 th WMA General Assembly Helsinki, Finland, June 1964 and amended by

More information

Boost the Success of Medical Device Development With Systematic Literature Reviews

Boost the Success of Medical Device Development With Systematic Literature Reviews FOR PHARMA & LIFE SCIENCES WHITEPAPER Boost the Success of Medical Device Development With Systematic Literature Reviews Biomedical literature supports medical Device development Before the ideation and

More information

Department of Defense INSTRUCTION

Department of Defense INSTRUCTION Department of Defense INSTRUCTION NUMBER 6200.02 February 27, 2008 SUBJECT: Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs USD(P&R) References:

More information

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth

More information

It addresses technovigilance rules applicable to registration holders for health products in Brazil.

It addresses technovigilance rules applicable to registration holders for health products in Brazil. RESOLUTION - RDC NO. 67, FROM DECEMBER 21, 2009 It addresses technovigilance rules applicable to registration holders for health products in Brazil. The Collegiate Director Board of Agência Nacional de

More information

Medical Product Development Certificate Program

Medical Product Development Certificate Program Life Sciences Medical Product Development Certificate Program Accelerate Your Career extension.uci.edu/mpd In today s competitive business environment, leaders are appointed based on credentials and experience.

More information

SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS

SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS June 2006 1 INTRODUCTION Public health concerns demand that the manufacture of pharmaceutical products and their subsequent handling

More information

23. The quality management system

23. The quality management system 23. The quality management system Version 2.0 On this page: Mandatory requirements: Extracts from the HFE Act Extracts from licence conditions HFEA guidance: Definition of the quality management system

More information