• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—June 3

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Medbio LLC

    Cirtec Medical

    Halkey-Roberts Corporation

    NDH Medical Inc.

    LEMO USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Cirtec Medical

    Halkey-Roberts Corporation

    NDH Medical Inc.

    LEMO USA Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Act Now to Prepare for MDSAP Audits

    ...

    Act Now to Prepare for MDSAP Audits
    Kim Trautman, Executive Vice President of Medical Device International Services, NSF International01.29.18
    The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certificate on file with Health Canada to maintain their Canadian Device Licenses.

    MDSAP will replace the current Canadian Medical Device Conformity Assessment System (CMDCAS) as a way to demonstrate quality management system compliance to ISO 13485 and the Canadian Medical Devices Regulations (CMDR). Australia, Brazil, Japan, and the U.S. are also participating in the MDSAP. Each regulatory jurisdiction is utilizing MDSAP differently depending upon how regulators are allowed to legally employ the outputs of such an internationally harmonized audit. Brazil, Japan, and Australia use the MDSAP audit report as a substitute for their regulatory inspectorates’ reports for medical device applications or authorizations, while the U.S. Food & Drug Administration (FDA) uses them as an alternative to its inspectorates’ audit reports for routine medical device inspections.

    While January 2019 may seem far off, preparing for the MDSAP takes time and there are a limited number of authorized third-party auditing organizations (AO) available to conduct MDSAP audits. About five AOs are currently handling nearly 90 percent of all CMDCAS certifications—not nearly enough to meet the demand created by the Canadian MDSAP mandate.

    The Perfect Storm
    The world’s larger medical device manufacturers are setting internal mandates for their businesses, including compliance with ISO 13485:2016. Additionally, new European Union (EU) Medical Device and In-Vitro Diagnostic Device Regulations, published in May, require all medical devices be recertified to the new regulations in the next few years. Moreover, the new EU regulations dictate that all EU notified bodies become re-designated. With many of the MDSAP auditing organizations also being EU notified bodies, there will undoubtedly be a strain on resources to meet demands. These factors, as well as marketing pressures in jurisdictions such as China, Singapore, and Malaysia, will increase the volume of regulatory audit work as well as a potential backlog that could impact device manufacturers.

    In response to this increased demand for authorized AOs and other global market and regulatory drivers, NSF Health Sciences Certification LLC applied to become an MDSAP auditing organization last year. The MDSAP Regulatory Authority Council requires auditing organizations have expertise in a manufacturer’s quality systems and product type and design, which limits the pool of entities qualified to become MDSAP AOs. This small band of AOs allows for easier enforcement of program requirements and inspires more confidence from regulatory authorities but it also may complicate efforts to find an authorized AO able to conduct required audits as the 2019 deadline approaches. Thus, it’s important for manufacturers to immediately move forward with their MDSAP preparations. There is no time to procrastinate. At the current rate of MDSAP adoption, a number of manufacturers will likely be shut out of the Canadian medical device market—at least temporarily.

    A Logistical Nightmare
    For years, manufacturers have complained that multiple annual regulatory audits interrupted and distracted them from their primary jobs. When I was at the FDA developing  MDSAP requirements, a manufacturer shared a story that underscores the need for a single audit program. This firm employed 50 people at its small Asian facility. The FDA announced it was sending an investigator to perform a routine medical device inspection; as per procedure, the agency notified the Ministry of Health (MOH) in the home country of the manufacturing plant and offered to allow the MOH representative to shadow the FDA inspector. The MOH accepted and sent an auditor.

    On the day of the FDA inspection, however, an EU notified body agent arrived to perform an unannounced audit. To compound the burden on this small manufacturing facility, the next day, a regulatory audit team from Kazakhstan arrived to perform its own audit. Ergo, four different audit teams representing four different regulatory authorities converged on this small facility at once, creating a logistical nightmare for both the facility managers and regulatory audit teams.

    The international MDSAP was developed in 2012 to create a single audit system for multiple regulatory jurisdictions. The program covers ISO 13485 certification and other regulatory requirements beyond quality management systems (QMS), and provides various benefits, not the least of which are time and cost savings. MDSAP audits are becoming increasingly more popular and widely used globally.

    In addition, through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority, MDSAP allows regulatory resources to be used more efficiently, according to the FDA and MDSAP Regulatory Authority Council (RAC). The program also maximizes the use of existing conformity assessment structures and promotes the concept of greater alignment of regulatory approaches and technical requirements based on international standards and best practices on an international scale, the two regulatory bodies note.

    The program allows sufficient regulatory oversight of medical device manufacturers while having minimal burden on industry, and it helps promote consistency, predictability, and transparency of regulatory programs through standardization.

    Over the past decade, there has been a sharp increase in the number of regulatory authorities requiring their own audits. The number of emerging regulators placing medical device regulations into law has also grown during this time, and the volume of regulatory audits has mushroomed. Ideally, the MDSAP certificate and MDSAP audit report will be used by emerging regulatory schemes to prevent additional country-specific regulatory audits.

    Efficient Yet Thorough
    The MDSAP audit process ensures a single audit provides efficient, thorough coverage of QMS requirements covering:

    • ISO 13485
    • Brazilian Good Manufacturing Practices (ANVISA RDC 16)
    • Japanese requirements (MHLW MO 169)
    • FDA’s Quality System Regulation (21 CFR Part 820)
    • Country-specific registration and licensing requirements
    • Country-specific adverse event reporting requirements
    • Other country-specific requirements beyond QMS

    MDSAP also increases speed to market, especially in Brazil. In many jurisdictions, regulators lack the resources to perform required entrance-to-market audits. The MDSAP certificate or audit report replaces these regulatory inspections and allows manufacturers to enter multiple markets quicker.

    The MDSAP audit model is economically efficient as it maximizes the auditor’s time and spares the manufacturer from lengthy and expensive individual audits for each of the five regulatory jurisdictions. In some countries outside of the consortium with premarket QMS requirements, the MDSAP certification can be shown as evidence of compliance to regulatory mandates.

    MDSAP allows for more flexibility, since manufacturers can choose the third-party AO. Also, routine audits are announced and planned by both parties to accommodate schedules and avoid potential conflicts.

    Finally, MDSAP is expected to improve the predictability of audit outcomes through:

    • Enhanced auditing organization recognition criteria
    • Monitoring of auditing organizations by participating regulators
    • Use of a standard audit model
    • Grading of any nonconformity using objective criteria to characterize the significance of the finding
    • Reporting audit outcomes using a standard template

    Next Steps
    There are plenty of good reasons for companies to use MDSAP—the most notable being Canada’s requirement in 2019. Manufacturers must start preparing and scheduling their MDSAP audits now. Depending on the situation, it may take months to get ready for an MDSAP audit, assuming an authorized and qualified AO can be found.

    Companies that aren’t already prepared for MDSAP, can get started by following four steps.

    1. Learn about MDSAP. Enter “MDSAP” into any search engine for general information. Each of the five jurisdictions’ regulatory authority websites provide helpful information—the FDA site as well as Australia’s Therapeutic Goods Administration, Brazil’s ANVISA, Canada’s Health Canada, and Japan’s Pharmaceutical and Medical Devices Agency. The FDA website, which is the Regulatory Consortium’s official site, offers a comprehensive overview of the program while NSF.org highlights essential components and important details, including the MDSAP audit structure.

    2. Conduct a Gap Analysis. Also known as a needs assessment, a gap analysis is used to determine what an organization must do to move from its current state—in this case, meeting existing medical device certification requirements—to a future standard (i.e. compliance with ISO 13485:2016 and any specific country requirements). MDSAP tools such as the Audit Model provide a process map to verify the inclusion/implementation of regulatory requirements following ISO 13485:2016.
    The Audit Model and the Audit Model Companion Guidance document should not be relied upon for exact regulatory requirements because slight discrepancies exist. Instead, the model and guidance document should be used as a reference and an audit preparation tool. It is essential to read the regulations of the five jurisdictions for specifics on each. The FDA website includes an MDSAP Frequently Asked Questions document which is also quite useful.

    3. Take Action Based on the Gap Analysis. Prioritize actions to address areas of greatest urgency first.

    • Understand the regulatory requirements thoroughly to avoid mistakenly placed resources and insufficient implementation.
    • Perform a proper root cause analysis wherever discrepancies exist to understand what and/or why something happened.
    • Fix any problems and implement corrective actions to ensure they don’t recur.
    • Use the “verification of effectiveness” process to ensure successful implementation. This process is widely misunderstood and often incorrectly performed, but it’s an essential step in analyzing QMS health.
    • Acquire, leverage, and approve needed resources while ensuring that management understands the costs (time and money) needed to implement the requirements.
    • Acquire necessary training for responsible parties.
    • Assume ownership (along with top management) of the QMS.

    4. Choose an authorized Auditing Organization. The FDA website includes a list of all AOs authorized to conduct MDSAP audits. Be sure to consider factors such as expertise, cost, availability, and experience. Schedule the audit no later than September 2018 in order to ensure ample time to utilize that audit for Health Canada Licensing purposes. 


    Kim Trautman led development of the MDSAP for the U.S. FDA. Today she is executive vice president of medical device services at NSF International.
    Related Searches
    • compliance
    • standards
    • monitoring
    • vice president
    Suggested For You
    MEDICAL & BIOTECH MANUFACTURING MEDICAL & BIOTECH MANUFACTURING
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    Molli Surgical Molli Surgical's Breast Tumor Marker
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    Vicarious Surgical Opens New Corporate Headquarters in Massachusetts Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board

    Related Literature / Brochures

    • MEDICAL & BIOTECH MANUFACTURING

      ISO 13485:2016 • FDA Registered

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • Tubing & Extrusion
      Accu-Tube Appoints Matthew Haddle as CEO

      Accu-Tube Appoints Matthew Haddle as CEO

      Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.
      Accu-Tube 09.22.21


    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21

    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • MPO's Most-Read Stories This Week—June 3
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    World Taste & Smell Association's June 6 Webinar Looks at Smell and Multisensory Design
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login