• 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
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    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
    I-VASC Raises 1.8M Euros in Series A Funding

    Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data

    FDA Clears Truvic's Prodigy Thrombectomy System

    Medical Device CEO Charged With Tax Evasion

    MPO's Most-Read Stories This Week—May 21
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    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
    Cirtec Medical

    Trademark Plastics Inc.

    BMP Medical

    Xact Wire EDM Corp.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Trademark Plastics Inc.

    BMP Medical

    Xact Wire EDM Corp.

    Fusion Biotec 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
    Editorial

    The Sleeping Giant

    ...

    Related CONTENT
    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    • Accu-Tube Appoints Matthew Haddle as CEO
    • First CellFX Procedure Performed in Canada
    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    • CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Christopher Delporte, Editorial Director04.08.14
    In the not-so-distant past, many medical device companies saw China as a panacea—the end-all and be-all low-cost production solution to increasingly expensive labor and manufacturing in the United States and Europe. Well, the euphoria didn’t last that long. Most companies quickly realized that cost as a reason alone was not enough to justify manufacturing in China given increasingly obvious examples of the country’s quality and intellectual property security shortcomings. Today, the mantra is “China for China” or “China for Asia,” altering a strategy of manufacturing lots of parts, assemblies or finished goods and sending them back to the West. Companies are looking at an overall strategy for supplying the region—and its growing billions of consumers—before moving production or R&D facilities to the land of the sleeping giant (which, incidentally, is a nickname given to China by Napoleon Bonaparte. The diminutive French military leader is rumored to have pointed to a map of China and said something akin to: “There is a sleeping giant. Let him sleep. If he wakes, he will shake the world.” He had no idea how right he would be.)

    In the medical device world, the United States remains the powerhouse market—by manufacturing volume and consumption of goods. But if you look over your shoulder, you’ll notice that the giant has more than one eye open and he’s stretching after his long nap.

    It seems that regulators in China want to address some of the issues that have plagued medtech manufacturing in their country. A new set of regulations, set to go into effect in June, will increase fines and toughen oversight of the country’s fast-growing medical device sector as it overhauls outdated laws to stamp out corporate malpractice.

    China is trying to get out in front of issues that regulators in the United States have been tackling for years. For example, U.S. authorities have fined AGA Medical Corp. and Biomet Inc. millions of dollars for corporate malpractice in China, while Germany’s
    Siemens AG faced a lawsuit in the United States over its China operations. The case was dismissed last year.

    The new regulations raise the fine for illegal manufacturing or selling of medical equipment to 20 times the value of the goods,
    according to documents recently published on China’s State Council website. The original law, established in 2000, set a cap at five times the value. Under the updated rule, medical equipment in China will be registered and divided into three categories based on the potential health risks they could pose to public health. High-risk equipment will be placed under stricter control by China’s regulatory authorities. Manufacturers or operators of high-risk medical equipment without proper clearance will have their illegal profits seized, along with having the technology and/or materials confiscated. In addition to the heftier fines, violators also could face criminal charges, according to the new regulations. In the most serious cases, firms that sell products illegally could be banned from applying for an operating license for up to five years.

    “The new rules increase the range of possible punishments, and the level of fines for the most serious violations,” government officials said in a Q&A published on the State Council’s website. Violations include operating without relevant licences or misleading regulators. “In recent years, we’ve seen some issues of illegal behavior, and the legal foundation for striking back has not been clear enough. To resolve the problem, we needed a complete revision of the existing legislation,” officials added.

    The stricter policy will not go unnoticed, as medtech multinationals race to the market.

    Increasingly attractive data and demographics have attracted some of the largest global medtech firms to establish operations in China, including Siemens Healthcare, GE Healthcare, Philips Healthcare, Johnson & Johnson and Medtronic Inc., which compete with local companies such as Mindray Medical International Ltd., China Resources Wandong Medical Equipment Co. Ltd., and MicroPort Scientific Corp. (which recently purchased the large-joint assets of Wright Medical Group Inc. and rebranded as MicroPort Orthopedics Inc.).

    According to research firm Global Data, China’s medical device market may double to more than $50 billion by 2020 (current worldwide market value of the medical device sector is projected at approximately $375 billion). The country’s population of nearly 1.4 billion is a magnet for life-science companies looking to cash in as China’s healthcare network becomes less rural, better funded and much more sophisticated.

    Sleeping giant indeed.

    Christopher Delporte
    Editorial Director
    cdelporte@rodmanmedia.com
    Related Searches
    • lifepak 1000 defibrillator
    • Contract Manufacturing
    • medical device companies
    • Materials
    Related Knowledge Center
    • Contract Manufacturing
    • Materials
    Suggested For You
    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
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    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
    Sight Sciences Files Patent Suit Against Ivantis Sight Sciences Files Patent Suit Against Ivantis
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    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
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    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

    Related Content

    • 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

    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 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


      Breaking News
      • I-VASC Raises 1.8M Euros in Series A Funding
      • Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      • FDA Clears Truvic's Prodigy Thrombectomy System
      • RSIP Vision Develops New AI Tool for Prostate MRI Analysis
      • Medical Device CEO Charged With Tax Evasion
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      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

      Vitafoods Europe 2022 Attendance Returns to 2019 Level
      Beyond Raw Launches Concept X Pre-Workout Line
      Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort
      Coatings World

      Latest Breaking News From Coatings World

      PPG’s Diane Kappas Recognized as ‘Woman of Influence’ by Pittsburgh Business Times
      BEHR Launches COPPER FORCE Interior Paint
      A New Kind of Primer: Demand for Interior and Exterior Paint Experts Remains High, J.D. Power Finds
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      I-VASC Raises 1.8M Euros in Series A Funding
      Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      FDA Clears Truvic's Prodigy Thrombectomy System
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Thermo Fisher, Qatar Genome Program Partner to Advance Precision Medicine
      CPC Launches AseptiQuik Genderless Connector
      Aptamer Group and PinotBio Extend Collaboration Agreement
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      L’Oréal USA Names Han Wen as Chief Digital & Marketing Officer
      NPD Group Reports on Rising E-commerce Sales in China for Prestige Beauty
      Noon Aesthetics Celebrates Ten Years with New Skincare Products
      Happi

      Latest Breaking News From Happi

      Gabriel Letizia Jr. Sentenced to 60 Months in Prison for Falsifying Sunscreen Test Results
      Coptis Appoints Marie Renee Thadal Vice President of Sales and Operations
      Han Wen Appointed L’Oréal’s New Chief Digital, Marketing Officer
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Avery Dennison announces Core Series Portfolio Tape Selector App
      HP Indigo reaches 2,000th active install milestone
      Brook + Whittle's new acquisition, SunDance goes to HP and more
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Ahlstrom-Munksjö Announces Reorganization of Decor Business Ownership
      Jones Names COO
      Ontex Conducts Pilot Program of Digital Incontinence Care Solution
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tom Hedman Named Senior Principal Scientist at Spinal Simplicity
      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      Copyright © 2022 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