Comparing Medical Device Law & Regulations of Japan, EU and US

Size: px
Start display at page:

Download "Comparing Medical Device Law & Regulations of Japan, EU and US"

Transcription

1 Competent Authority, Related Organization Laws Regulations License /or Registration of each type of Business Population: 127 million Ministry of Health, Labor Welfare( MHLW), -Pharmaceutical Food Safety Bureau, - Office of Medical Device Control - Office of Compliance - Pharmaceutical Affairs office of each Government Prefectures - Review Audit by Pharmaceutical Medical Device Agency (PMDA): about 30 specialists Registered Certification Body (RCB) :14 (JQA, TUV/RH, TUV/SUD, BSI, UL, SGS etc) Pharmaceutical Affairs Law (PAL) New PAL promulgated in July 2002, enforced as of April 1, 2005 to harmonize with GHTF adopt Quality Management System (QMS), Essential Principles. PAL Enforcement Ordinance, PAL Enforcement Regulation, GQP (Good Quality Practice),GVP (Good Vigilance Practice),QMS (Quality Management System) GCP (Good Clinical Practice) promulgated in July 2004 July Many Ordinances Notices issued up till now. Transfer of Certification or Approval (KISAI-SEIBI: June 8, 2007) for medical devices approved or notified under Old PAL must be done until the next renewal of license of MAH (2006 March 2010) Technical Stards (JIS) for Certification (396), Approval (35) IVD Reagent Certification (8 groups, 366) Comparing Medical Device Law & Regulations of Japan, EU US April 2008.Medical Device Consulting Japan Population: 493 million, 27 countries EC unit F3:Medical Device & Cosmetic Competent Authority of each Member States The following Licenses are required for MD business, 1. License for Manufacturer (4,269 as of 2007) 2. Accreditation of Foreign Manufacturers (about 1,000) 3. License for Marketing Authorization Holder (MAH: 2,676) who is responsible for marketing medical devices was Manufacturer or Importer of MDs under Old PAL. 3 controllers are required, Marketing Supervisor, Safety Control manager, Quality Assurance manager (quite unique compared with US, EU) 4. License for Retail Rental Business of ClassⅡ- Class Ⅳ MDs Registration for sales of ClassⅠ 5. License for Repair Business of each Technical Support Office Notified Body (NB) : About 70 (BSI, TUV/RH, TUV/SUD, KEMA, etc) Notified Body (NB) in Japan: BSI, TUV/RH, TUV/SUD, SGS,etc. 90/385/EEC Active Implantable Medical Devices Directive(AIMDD) 93/42/EEC Medical Devices Directive(MDD) 98/79/EEC In Vitro Medical Devices Directive (IVDD) Essential Requirements of each Directives Harmonized Stards (EN,IEC,ISO) MEDDEV Guidance Documents : Vigilance Guidance MEDDEV Rev 5 (effective from Jan..1, 2008) 98/47/EEC Revised Medical Devices Directive (revised in September 2007) The following contents are mainly mentioned on MDD. Registration of Representative Authority (Initial Distributor in EU) Registration of Manufacturer List of Device Category Products Number of Japanese manufacturers registered is about Population: 303 million FDA (Food & Drug Administration) CDRH (Center for Devices Radiological Health) : about 1,000 reviewers specialists Review of 510(k) by Third Party Accredited Bodies such as UL TUV America, TUV/RH, BSI etc Food, Drug Cosmetic Act of Medical Device Amendments (MDA) 1990 Safe Medical Device Act 1997 FDA Modernization Act 2002 Medical Device User Fee FDA Modernization 21CFR: Code of Federal Regulation, Food Drugs 801 Labeling 807 Establishment registration device listing for manufacturers initial importers of devices 814 Pre-Marketing Approval (PMA) 820 Quality System Regulation (QSR) Many Guidelines related to CFR Recognized Consensus Stards Initial Registration of Device Establishment : Manufacturer including Foreign Manufacturer Initial Importer shall be registered into FDA File. Annual Device Listing of the manufacturer shall be provided to FDA/CDRH Number of Japanese manufacturers registered is 605 as of Oct MDC Japan 1

2 Classification of MDs Requirements for Marketing Annex 8 Medical Device Classification Class Ⅰ, Ⅱa,Ⅱb, Ⅲ IVD is included in the category of Medical Device. Although 2000 MDs were classified under Old PAL, 4000 MDs have been defined based on GMDN classified. into 4 classes under New PAL, so many devices are newly included as MD about 200 MDs were changed from Class Ⅰto higher classes, so called Class-Up MDs. Class Ⅰ(General Medical Device :Malfunction causes only minor effect on human body) : X-ray film, surgical steel knife etc are required Notification only. ClassⅡ(Controlled Medical Device:Malfunction raises low possibility of life threatening effect or serious injury) : About 400 MDs with Certification Stard (JIS) : X-ray, CT, Ultrasound, EKG, Endo-scope etc shall comply with the applicable stard Essential Principles which are same to Essential Principles of GHTF be applied to Registered Certification Body (RCB). MDs without JIS shall comply with Essential Principles be applied to PMDA Class Ⅲ (Highly Controlled Medical Device : Malfunction cause substantial effect on subjects) : Dialyzer, Radio-therapy system, Respirator, etc MDs shall comply with Essential Principles be applied to PMDA. MDs with Approval Stard (35 Std.) shall comply with the stard Essential Principles Depending on the intended use materials Bio-compatibility test, Sterilization Validation /or Clinical Study are required. Class Ⅰ: Annex 7 Technical File of the MD, Declaration of Conformity by the manufacturer CE Marking. Serialized MD measuring MD must be certified by NB ClassⅡa : Annex 7 + Annex 2 or (Annex 4 or 5 or 6) 1. Certification for Full Quality System (ISO 13485) of the manufacturer by NB 2. Technical File of the MD to show compliance with Essential Requirements inspection by NB 3. Declaration of Conformity by the manufacturer 4. CE Marking Class Ⅱb :Diagnostic X-ray, CT, etc.: Annex 7 + Annex 2 or (Annex or 5 or 6) 1. Certification for Full Quality System (ISO 13485) of the manufacturer by NB 2. Technical File of MD to show compliance with Essential Requirements inspection by NB 3. Declaration of Conformity of the MD by the manufacturer with Technical File 4. CE Marking Medical Device Classification : Class Ⅰ,Ⅱ,Ⅲ General Controls: Common controls for all medical devices, such as Initial Registration of Device Establishment Initial Importers, Device listing, GMP/QSR etc ClassⅠ: X-ray tubes, Vacuum Tubes, etc 510(k) (Pre-market Notification) is not required except specific devices. ClassⅡ: Substantial equivalence to other products (Predicate Device) in commercial distribution, such as Diagnostic X-ray system, Ultrasound, CT, MRI, EKG etc 510(k) submission needs the device name, the establishment registration number, the class, action taken to comply with the requirements of the act for performance stard, proposed labels, labeling documents indicating the device is substantially equivalent to predicate devices. For medical device contained Software, manufacturers must submit the documents of the Software including Risk Analysis Verification & Validation Data. MDC Japan 2

3 Classification Requirements for Marketing Time scale to get Marketing Class Ⅲ : Implantable MDs in heart or Central Nerve etc. Annex 2 including Sec. 4 or (Annex 3 + Annex 4 or 5) 1. Clinical Investigation approved by Competent Authority of Member State 2. Certification for Full Quality System of the manufacturer by NB 3. Type Test of the MD for Essential Requirements by NB 4. Review Design Dossier of the product Pre-market inspection by NB, then Approval of CE Marking Class Ⅳ (Highly Controlled Medical Device : Invasive Device of which malfunction may cause life threatening effects): Implantable pace maker, stent etc. shall comply with Essential Principles be applied to PMDA. New MDs are required GLP (Good Laboratory Practice, Pre-Clinical tests) Clinical Study based on GCP Notice Remark points on Application for Marketing Approval for Medical Devices (No , dated Feb ) Attachment 1 shows the list of example of Medical Devices required Clinical Study Class Ⅱ: MDs with Certification Stard (JIS) shall be reviewed QMS of the manufacturer shall be audited by Third Party Certification Body. Certification time is 1 3 months depending on quality of documents QMS. Certification Fee is less than 1 million yen depending on RCB numbers of application per year Class Ⅲ: MDs with without Approval Stard shall be reviewed by PMDA the QMS shall be audited by Inspectors of each Government Prefecture. Approval Time is 6 to 18 months. Review fee without JIS of PMDA is 1,232.8 kyen. Review fee with JIS of PMDA is kyen. Class Ⅳ: shall be reviewed by PMDA, review time depends on the quality of application documents QMS. The review fee for approval is 3,741 kyen excluding consultation fee by PMDA. New MD: Period for Clinical Study is 1 3 years depending on the intended use number of applicable patients. Review fee of GLP & Clinical Study of PMDA is 2,697.7 kyen. Cost of Clinical Study is 10 million 100 million yen. Class Ⅱa, Ⅱb Audit of ISO inspection of compliance of MDD by NB; Audit of NB takes 3 5 days depending on the size of manufacturer quality of Technical File etc of the MDs Class Ⅲ, depending on period of Clinical Investigation Type Test by NB Clinical Investigation (MDD Article 15) is required for Class Ⅲ Implantable/ invasive Class Ⅱa orⅡb MEDDEV : Talks about evaluation of medical device clinical data Class Ⅲ (Implantable MDs, Vascular Stent, Artificial Heart New MD etc) : is required to meet General Controls, approval of IDE(Investigational Device Exemption for Clinical Study) PMA (Pre-market Approval) with submission of documents for each of 4 modules Class Ⅱ: After submitting documents for 510(k), it takes 2 6 months to get clearance depending on the quality of the documents response to questions from FDA or Third Party. Class Ⅲ: IDE + Clinical Study takes 6 months 2 years After submitting application documents of 4 modules for PMA to FDA, it takes min. 6 months average 8 months to get approval depending on the report of Clinical Study, quality of documents response to FDA. the result of PMA Inspection for manufacturer MDC Japan 3

4 Quality Management System/GMP Adverse Event or Incident Report to Competent Authority Manufacturer must establish QMS based on New QMS Regulation (almost equivalent to ISO 13485) Marketing Authorization Holder must establish QMS based on GQP Post Marketing Vigilance System based on GVP. Manufacturer of Class ⅡMD with Certification Stard (JIS) is audited by RCB. Manufacturers of ClassⅡMD without JIS or Class Ⅲ or Ⅳ is audited by inspectors of Government Prefecture Manufacturers of New MD is audited by PMDA The QMS of Foreign Manufacturer will be audited by PMDA or RCB based on QMS regulation. At every application for Certification or Approval for MD QMS audit is done for the manufacturer of MD. It is quite unique too much cost. Adverse Event or Incident Report: Chapter 10 of PAL Enforcement Regulation When Marketing Authorization Holder notices any of the following cases, they shall inform the Minister PMDA within the period specified in each item, (1) 15 days report of death, which are suspected to be due to faults of the medical device or the medical device used in foreign country, or the occurrence of cases attributable to infection diseases suspected to be associated with the use of the medical device, etc. (2) 30 days report of the occurrence cases such as Disabling, potential leading to death or disabling etc. (See Chapter 10, Article 253 about detail) The number of the report is increasing, because penalty for violation was enforced strongly In ,252 reports In ,000 reports Quality Management System (ISO13485) : Audit for manufacturer Certification by NB Incident Report Recall (Article 10 of MDD) Vigilance Guideline MEDDEV Rev.5 1. Old MEDDEV requires reporting Incidents within 10 or 30 days., now replaced by immediately 2. Incident Event Reporting to relevant Competent Authority (CA) 1) Serious public health threat : Report immediately (without any delay that could not be justified) but not later than 2 calendar days after awareness by the manufacturer of the threat. 2) Death or Unanticipated serious deterioration in state of health : Report immediately (without any delay that could not be justified) after the manufacturer established a link between the device the event but not later than 10 elapsed calendar days following the date of awareness of the event 3) Others : Report immediately (without any delay that could not be justified) after the manufacturer established a link between the device the event but not later than 30 elapsed calendar days following the date of awareness of the event 3. Reporting of use errors to relevant CA 21 CFR 820 QSR(Quality System Regulation) : Almost same to ISO Audit for manufacturer by FDA takes normally 3 5 days depending on the size quality of manufacturer FDA audit focuses to Management Responsibility, Design Control including Risk Analysis, Process Validation, Complaint Hling Corrective Preventive Actions (CAPA) MDR (Medical Device Reporting) : CFR 803 Manufacturers are required to report an individual adverse event (MDR) to FDA from becoming aware of an event as follows, 1) 5 day reports on events that require remedial action to prevent an unreasonable risk of substantial harm to the public health other types of events designated by FDA 2) 30 day reports of deaths, serious injuries that is life threatening, even if temporary in nature malfunctions MDR in ,000 MDR in ,000 MDC Japan 4

5 Japan EU US Recall Removal Marketing Authorization Holder must report to Government Prefecture PMDA in case of Recall Removal Class Ⅰ (most urgent important) Ⅱ Ⅲ In 2005 number of Recall was 322 In 2006 was 365 Field safety Corrective Action (FSCA) Field Safety Notices (FSN) 1) Recall Notice now replaced by FSCA,but covers recall as well 2) FSCA should be notified to relevant CA NB via FSN 3) If recall is ordered outside EU but product sold in EU, FSCA must be notified to relevant CA Recall to FDA (Corrections Removals) Classification of Recall : Ⅰ(most urgent important) Ⅱ Ⅲ Number of Recall in 2005 was 571 In 2006 was 630 MDC Japan 5

Med-Info. New Act on Medical Devices in Japan. TÜV SÜD Product Service GmbH. International expert information for the Medical Device industry

Med-Info. New Act on Medical Devices in Japan. TÜV SÜD Product Service GmbH. International expert information for the Medical Device industry Med-Info International expert information for the Medical Device industry New Act on Medical Devices in Japan New Act on Medical Devices (PMD Act) to be launched on November 25, 2014 Practice-oriented

More information

UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES A WHITE PAPER ON THE REQUIREMENTS, REGULATIONS AND OPPORTUNITIES CONTAINED IN EC DIRECTIVE 98/79/EC AND A BRIEF COMPARISON

More information

Vigilance Reporting. Vicky Medley - Head of QMS, Medical Devices. September 2015. Copyright 2015 BSI. All rights reserved.

Vigilance Reporting. Vicky Medley - Head of QMS, Medical Devices. September 2015. Copyright 2015 BSI. All rights reserved. Vigilance Reporting Vicky Medley - Head of QMS, Medical Devices September 2015 2 Why? 3 protecting and improving public health https://www.gov.uk/government/organisations/medicines-and-healthcareproducts-regulatory-agency/about

More information

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical

More information

Registration of Class B Medical Devices

Registration of Class B Medical Devices Registration of Class B Medical Devices 1 INTRODUCTION Medical devices are classified based on a rule based risk classification system into four risk classes Class A to D with Class A being the lowest

More information

Global Regulatory Requirements for Medical Devices

Global Regulatory Requirements for Medical Devices Mälardalen University Department of Biology and Chemical Engineering Global Regulatory Requirements for Medical Devices Sandra Brolin Supervisor at Synergus AB Lian Zhang Examiner at Mälaren University

More information

Lessons Learned From the Mistakes of Others

Lessons Learned From the Mistakes of Others Lessons Learned From the Mistakes of Others Keisuke Kaye Suzuki March 30, 2007 Basic Market Entry Models Direct Operation Market Penetration Operational Expenses Commercial Investment Risk + Joint Venture

More information

Section 5: Quality Systems Regulation (QSR) and Good Manufacturing Practice (GMP)

Section 5: Quality Systems Regulation (QSR) and Good Manufacturing Practice (GMP) Section 5: Quality Systems Regulation (QSR) and Good Manufacturing Practice (GMP) 1 Quality Systems Regulation (QSR) 2 Quality Systems Regulation (QSR) and Good Manufacturing Practice (GMP) Sets of checks

More information

Clinical evaluation Latest development in expectations EU and USA

Clinical evaluation Latest development in expectations EU and USA Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.

More information

Med-Info Regular Information Bulletins for the Medical Device Industry

Med-Info Regular Information Bulletins for the Medical Device Industry Med-Info Regular Information Bulletins for the Medical Device Industry Product Service Globalization of Medical Device Approval Mutual Recognition Agreements (MRA) between the EU and the USA and Australia

More information

Application for Accreditation of Foreign Manufacturers

Application for Accreditation of Foreign Manufacturers Application for Accreditation of Foreign Manufacturers (This English document is only for reference purpose. In case of any discrepancy, the Japanese text shall prevail. For further information, please

More information

BSI Road Show: September 8 th to 15 th, 2014

BSI Road Show: September 8 th to 15 th, 2014 BSI Road Show: September 8 th to 15 th, 2014 Post Market Surveillance (including PMCF): common non compliances Ibim Tariah Ph.D Technical Director, Healthcare Solutions Itoro Udofia Ph.D Global Head, Orthopaedics

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

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com

More information

Medical Device Classification

Medical Device Classification Medical Device Classification Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 1 Speaker Biography Dan O Leary Dan

More information

RAPS ONLINE UNIVERSITY

RAPS ONLINE UNIVERSITY RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.

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

Reporting Changes to your Notified Body

Reporting Changes to your Notified Body Reporting Changes to your Notified Body Vicky Medley - Head of QMS, Medical Devices September 2015 1) Requirements & Guidance 2) Reporting Changes - What, When, Why & How 3) Some examples 4) Summary &

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

How To Know If A Mobile App Is A Medical Device

How To Know If A Mobile App Is A Medical Device The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation

More information

Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance

Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance February 27, 2014 Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com 1 Essential Requirements n Submit MDR reportable events to FDA

More information

Medical Device Marketing Authorization System (MDMA) MDMA User Manual

Medical Device Marketing Authorization System (MDMA) MDMA User Manual Medical Device Marketing Authorization System (MDMA) MDMA User Manual FOR THE Saudi Food & Drug Authority Document Version: ١ Date: April, ٤ th, ٢٠١١ Table of Contents FOR THE... ١ Saudi Food & Drug Authority...

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

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

Medical Devices: CE Marking Step-by Step

Medical Devices: CE Marking Step-by Step Medical Devices: CE Marking Step-by Step Sylvia Mohr Standards Specialist U.S. Mission to the European Union 1 Introduction CE marking in 8 Steps Overview intended purpose - technical documentation classification

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

ORACLE CONSULTING GROUP

ORACLE CONSULTING GROUP ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739

More information

Medical Device Training Program 2015

Medical Device Training Program 2015 Medical Device Training Introduction Supplementary training and education is often overlooked by medical device professionals until it is triggered by an upcoming FDA or Notified Body and/or ISO 13485

More information

Regulatory Considerations for Medical Device Software. Medical Device Software

Regulatory Considerations for Medical Device Software. Medical Device Software Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan

More information

Want to know more about the Notified Body?

Want to know more about the Notified Body? NBG/V 2/07/14 BSI Notified Body (0086) Kitemark Court Davy Avenue Knowlhill Milton Keynes MK5 8PP United Kingdom T: +44 845 080 9000 E: eu.medicaldevices@bsigroup.com W: medicaldevices.bsigroup.com Want

More information

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY Directorate F-Consumer Good Unit F3- Cosmetic and Medical Devices MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 5 April 2007 GUIDELINES ON A MEDICAL

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

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

Auditing as a Component of a Pharmaceutical Quality System

Auditing as a Component of a Pharmaceutical Quality System Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a

More information

CDRH Regulated Software

CDRH Regulated Software CDRH Regulated Software An Introduction John F. Murray Jr. CDRH Software Compliance Expert CDRH Regulates Software in the following areas Medical Devices Automation of Production Systems Automation of

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

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

Pre-market Information - Class III and IV

Pre-market Information - Class III and IV 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)

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

JUL 2 2008. Ms. Kendra Basler Regulatory Affairs Associate Abbott Vascular Cardiac Therapies 3200 Lakeside Drive Santa Clara, CA 95054-2807

JUL 2 2008. Ms. Kendra Basler Regulatory Affairs Associate Abbott Vascular Cardiac Therapies 3200 Lakeside Drive Santa Clara, CA 95054-2807 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service JUL 2 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Kendra Basler Regulatory Affairs Associate Abbott Vascular

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

BSI: An In Vitro Diagnostics Notified Body. A guide to the In Vitro Diagnostic Directive....making excellence a habit.

BSI: An In Vitro Diagnostics Notified Body. A guide to the In Vitro Diagnostic Directive....making excellence a habit. BSI: An In Vitro Diagnostics Notified Body A guide to the In Vitro Diagnostic Directive...making excellence a habit. A BSI guide to the In Vitro Diagnostic Directive Introduction In Vitro Diagnostics (IVD)

More information

Safeguarding public health The Regulation of Software as a Medical Device

Safeguarding public health The Regulation of Software as a Medical Device Safeguarding public health The Regulation of Software as a Medical Device Dr Head of New and Emerging Technologies Medicines and Healthcare Products Regulatory Agency (MHRA) Crown Copyright 2013 About

More information

GUIDELINES ON MEDICAL DEVICES

GUIDELINES ON MEDICAL DEVICES EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics MEDDEV 2.7/3 revision 3 May 2015 GUIDELINES ON

More information

GUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

GUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues 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. 2.14/1 rev. 1 January

More information

Med-Info. Malaysia Medical Device Regulations. TÜV SÜD Product Service GmbH. International expert information for the medical device industry

Med-Info. Malaysia Medical Device Regulations. TÜV SÜD Product Service GmbH. International expert information for the medical device industry Med-Info International expert information for the medical device industry Malaysia Medical Device Regulations Passed in 2012, the Medical Device Act (Act 737) and the Medical Device Authority Act 2012

More information

I. Scope This Notification applies to medical devices other than those that require a preliminary

I. Scope This Notification applies to medical devices other than those that require a preliminary Provisional Translation (as of March 2010) PFSB/ELD/OMDE (Yakushokuki) Notification No. 0216001 February 16, 2005 To: Directors of Health Departments (Bureaus), Prefectural Governments From: Director of

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

Table of Contents. Preface 1.0 Introduction 2.0 Scope 3.0 Purpose 4.0 Rationale 5.0 References 6.0 Definitions

Table of Contents. Preface 1.0 Introduction 2.0 Scope 3.0 Purpose 4.0 Rationale 5.0 References 6.0 Definitions Table of Contents Preface 1.0 Introduction 2.0 Scope 3.0 Purpose 4.0 Rationale 5.0 References 6.0 Definitions 7.0 Objectives and User Needs of a Regulatory Audit Report 7.1 Audit report objectives 7.2

More information

PLM: Privat Label Manufacturer (Customer of the OEM-PLM relation) OEM: Original Equipment Manufacturer (Supplier of the OEM-PLM relation)

PLM: Privat Label Manufacturer (Customer of the OEM-PLM relation) OEM: Original Equipment Manufacturer (Supplier of the OEM-PLM relation) 1 Area of application of the product documentation in case of a Privat Label Manufacuter according to OEM procedure. To apply with new certification applications and sample evas in the context of the regular

More information

Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices

Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Experts in medical device quality systems, compliance, regulatory affairs, auditing and training www.nsf.org The Right People.

More information

A GUIDE FOR THE QUALITY ASSURANCE

A GUIDE FOR THE QUALITY ASSURANCE WHO/BCT/03.02 DISTR.: GENERAL A GUIDE FOR THE QUALITY ASSURANCE OF SINGLE USE INJECTION EQUIPMENT Final - 17 February 2003 World Health Organization, Department of Blood Safety and Clinical Technology,

More information

Conformity assessment certification

Conformity assessment certification TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA

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

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

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

0 EC2 92011 V-,) 133 Lj9a

0 EC2 92011 V-,) 133 Lj9a 0 EC2 92011 V-,) 133 Lj9a Section 5: 5 1 0(k) Summar 5 10(K) SUMMARY FOR SOMATOM DEFINITION Flash (with Stellar Detector) Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern,

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

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA In this presentation: App stats: Explosive growth Examples already cleared by the US FDA Is

More information

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM EUROPEAN COMMISSION DG Health and Consumers (SANCO) Directorate B-Consumer Affairs Unit B2- Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 8 January 2013 GUIDELINES

More information

May 5, 2015. Dear Mr. Courtney:

May 5, 2015. Dear Mr. Courtney: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 May 5, 2015 Terumo Cardiovascular

More information

GE Healthcare MAR 1 2013

GE Healthcare MAR 1 2013 K130155 Pagel1 of 2 GE Healthcare MAR 1 2013 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Submitter: Primary Contact Person: Secondary Contact Person:

More information

Understanding Medical Device Regulation for mhealth A Guide for Mobile Operators

Understanding Medical Device Regulation for mhealth A Guide for Mobile Operators for mhealth A Guide for Mobile Operators 1 Foreword Mobile technologies will make a significant contribution to addressing the enormous challenges of healthcare provision worldwide. Early efforts in mobile

More information

Basic Information about the European Directive 93/42/EEC on Medical Devices

Basic Information about the European Directive 93/42/EEC on Medical Devices Basic Information about the European Directive 93/42/EEC on Medical Devices mdc medical device certification GmbH Kriegerstraße 6 D-70191 Stuttgart, Germany Phone: +49-(0)711-253597-0 Fax: +49-(0)711-253597-10

More information

Software within the medical device regulatory framework in the EU

Software within the medical device regulatory framework in the EU Software within the medical device regulatory framework in the EU E-HEALTH WEEK (AMSTERDAM, 10 JUNE 2016) Erik Hansson, Deputy Head of Unit, DG GROWTH - Health Technology and Cosmetics, European Commission

More information

January 12, 2016. Dear Amy Yang:

January 12, 2016. Dear Amy Yang: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 12, 2016 Amy

More information

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document

More information

DICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314

DICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 DICOM Grid, Inc. Senior

More information

Medical Device Software Do You Understand How Software is Regulated?

Medical Device Software Do You Understand How Software is Regulated? Medical Device Software Do You Understand How Software is Regulated? By Gregory Martin Agenda Relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical

More information

GMP and QMS Regulation in Japan

GMP and QMS Regulation in Japan GMP and QMS Regulation in Japan Tomiko Tawaragi Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA) August 2 nd, 2014 1 st Brazil-Japan Seminar GMP/QMS GMP : Good Manufacture Practice

More information

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System NBOG s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 1 Introduction The

More information

Manual for ITC's clients, 2013. Conformity assessment of ACTIVE IMPLANTABLE MEDICAL DEVICES pursuant to Council Directive 90/385/EEC

Manual for ITC's clients, 2013. Conformity assessment of ACTIVE IMPLANTABLE MEDICAL DEVICES pursuant to Council Directive 90/385/EEC Manual for ITC's clients, 2013 Conformity assessment of ACTIVE IMPLANTABLE MEDICAL DEVICES pursuant to Council Directive 90/385/EEC Institute for Testing and Certification, inc., Czech Republic, EU 1.

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

March 20, 2015. Dear Mr. Chen:

March 20, 2015. Dear Mr. Chen: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 March 20, 2015 Biomate

More information

510(K) SUMMARY. 510(k) Number KOS'00-r

510(K) SUMMARY. 510(k) Number KOS'00-r " iirtual Ports Virtsua Ports Virtual Ports Ltd. 510(K) SUMMARY 510(k) Number KOS'00-r MAR 2 12008 Applicant's Name: Contact Person: Trade Name: Common name: Classification: Predicate Devices: Device Description:

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

CHAPTER 7 - RECALL ACTIVITIES

CHAPTER 7 - RECALL ACTIVITIES CHAPTER 7 INVESTIGATIONS OPERATIONS MANUAL 2015 CONTENTS CHAPTER 7 - RECALL ACTIVITIES 7.1.1.1 - Recall SUBCHAPTER 7.1 - RECALLS... 368 7.1.1 - DEFINITIONS... 368 7.1.1.1 - Recall... 368 7.1.1.2 - Recall

More information

How to apply for Medical Device License in Taiwan

How to apply for Medical Device License in Taiwan How to apply for Medical Device License in Taiwan According to Pharmaceutical Affairs Act (PAA), all medical devices regardless their classification shall apply for Medical Device License before they are

More information

Medical Device Reporting (MDR) 21 CFR Part 803

Medical Device Reporting (MDR) 21 CFR Part 803 Medical Device Reporting (MDR) 21 CFR Part 803 1 Objectives Review applicable sections of 21 CFR 803 and 21 CFR 820 Review and explain MDR reporting requirements Review FDA-483 observation examples 2 Medical

More information

Medical Device Reporting. Sharon Kapsch Office of Surveillance and Biometrics Center for Devices & Radiological Health Food & Drug Administration

Medical Device Reporting. Sharon Kapsch Office of Surveillance and Biometrics Center for Devices & Radiological Health Food & Drug Administration Medical Device Reporting Sharon Kapsch Office of Surveillance and Biometrics Center for Devices & Radiological Health Food & Drug Administration Session Overview Purpose: To provide information about the

More information

CENTER FOR CONNECTED HEALTH POLICY

CENTER FOR CONNECTED HEALTH POLICY CENTER FOR CONNECTED HEALTH POLICY The Center for Connected Health Policy (CCHP) is a public interest nonprofit organization that develops and advances telehealth policy solutions to promote improvements

More information

Corrections and Removals 21 CFR Part 806

Corrections and Removals 21 CFR Part 806 Corrections and Removals 21 CFR Part 806 Presented by: Kimberly Lewandowski-Walker Food and Drug Administration Division of Domestic Field Investigations Office of Regulatory Affairs From the Newsroom

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

Risk Management and the Impact of EN ISO 14971:2012 Annex Z

Risk Management and the Impact of EN ISO 14971:2012 Annex Z Risk Management and the Impact of EN ISO 14971:2012 Annex Z BSI 2014 Medical Device Mini-Roadshow Ibim Tariah Ph.D Technical Director, Healthcare Solutions Copyright 2014 BSI. All rights reserved. 1 Risk

More information

Public Law 113 283 113th Congress An Act

Public Law 113 283 113th Congress An Act PUBLIC LAW 113 283 DEC. 18, 2014 128 STAT. 3073 Public Law 113 283 113th Congress An Act To amend chapter 35 of title 44, United States Code, to provide for reform to Federal information security. Be it

More information

Achieving Global Approval for mhealth Devices and Products

Achieving Global Approval for mhealth Devices and Products Achieving Global Approval for mhealth Devices and Products Achieving Global Approval for mhealth Devices and Products The adaptation of wireless technologies is a key element in the overall effort by healthcare

More information

The Shifting Sands of Medical Software Regulation

The Shifting Sands of Medical Software Regulation The Shifting Sands of Medical Software Regulation Suzanne O Shea Ralph Hall September 10, 2014 What Software is Regulated by FDA? FDA regulates medical devices. FDA regulates software that meets the definition

More information

PREP Course #27: Medical Device Clinical Trial Management

PREP Course #27: Medical Device Clinical Trial Management PREP Course #27: Medical Device Clinical Trial Management Presented by: Evelyn Huang Jeffrey Revello Office of Research Compliance North Shore-LIJ Health System CME Disclosure Statement The North Shore

More information

2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002

2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002 STATUTORY INSTRUMENTS 2002 No. 618 CONSUMER PROTECTION The Medical Devices Regulations 2002 Made - - - - - 20th May 2002 Laid before Parliament 21st May 2002 Coming into force - - 13th June 2002 ARRANGEMENT

More information

April 7, 2015. Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025

April 7, 2015. Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 7, 2015 Acclarent,

More information

CAPA - the importance of data analysis

CAPA - the importance of data analysis CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 sue@qmsconsultant.com QMS Consulting, Inc. 2007 1 Topics Regulatory Requirements Design Controls and

More information

Clinical trials for medical devices: FDA and the IDE process

Clinical trials for medical devices: FDA and the IDE process Clinical trials for medical devices: FDA and the IDE process Owen Faris, Ph.D. Deputy Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health,

More information

CE-Marked Product List (MDD)

CE-Marked Product List (MDD) CE-Marked Product List (MDD) On March 21st the revised Directive 93/42/EEC concerning medical devices which includes the amendment M5 Directive 2007/47/EC of the European Parliament and of the Council

More information

D I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09, 201 0.

D I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09, 201 0. Section 5 D I Z1 510(k) Summary Date Prepared: September 09, 201 0 Submitter: Contact: Siemens Medical Solutions USA, Inc. 4040 Nelson Avenue Concord, CA 94520 Christine Dunbar Senior Regulatory Affairs

More information

October 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS

October 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Cavex

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

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

Q(K SVJM~jPagelIof 3

Q(K SVJM~jPagelIof 3 K13 0460 Q(K SVJM~jPagelIof 3 JUL 1 12013 This 51 0(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k)

More information

August 12, 2014. Oertli Instrumente AG Ms. Karin Rohr Head of Quality Management & Regulatory Affairs Hafnerwisenstrasse 4 CH 9442 Berneck Switzerland

August 12, 2014. Oertli Instrumente AG Ms. Karin Rohr Head of Quality Management & Regulatory Affairs Hafnerwisenstrasse 4 CH 9442 Berneck Switzerland DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service August 12, 2014 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Oertli

More information

CHAPTER 2. Pharmaceutical Laws and. Regulations 2. PHARMACEUTICAL AFFAIRS LAW 1. PHARMACEUTICAL LAWS

CHAPTER 2. Pharmaceutical Laws and. Regulations 2. PHARMACEUTICAL AFFAIRS LAW 1. PHARMACEUTICAL LAWS CHAPTER 2 Pharmaceutical Laws and Regulations 1. PHARMACEUTICAL LAWS Pharmaceutical administration in Japan is based on various laws and regulations, consisting mainly of: (1) the Pharmaceutical Affairs

More information