This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.
Our PCB 101 Presentation goes through the processes involved in manufacturing a printed circuit board.
From a simple single sided board to a complex multi-layer, double sided surface mount design, our goal is to provide you a design that meets your requirements and is the most cost effective to manufacture. Our experience in IPC Class III standards, very stringent cleanliness requirements, heavy copper and production tolerances allow us to provide our customers exactly what they need for their end product.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
PCBA Assembly Process Flow / PCB Assembly Manufacturing introduces the basic manufacturing process of PCBA / PCB assembly in different condition of component.It is about PCBA manufacture production.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Similar to Strategies for Device Approval in China, India, South Korea and Australia (20)
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
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Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
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This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
0x01 - Newton's Third Law: Static vs. Dynamic Abusers
Strategies for Device Approval in China, India, South Korea and Australia
1.
2. Strategies for getting your
device approved in Australia,
China, India and South Korea
Presented by:
Evangeline Loh, Ph.D. RAC (US, EU)
Vice President, Global Regulatory Affairs
Austin, Texas office
evangeline@emergogroup.com
3. What we will cover
AUSTRALIA
CHINA
INDIA
SOUTH KOREA
5. Australian market appeal
• Population of 23 million.
• 12th largest global economy, about the
same as Canada.
• Device market totals US$ 5-7 billion.
• Expected to decrease 2.3% annually.
• A weakening Australian dollar will slow
market growth in coming years.
6. Australian regulatory
process for medical devices
• Regulated by the Australian Therapeutic
Goods Administration (TGA), within the
Australian Department of Health.
• Legal framework for the regulatory system is
based on the Therapeutic Goods Act 1989
and Therapeutic Goods (Medical Devices)
Regulation 2002.
• Medical devices must meet the requirements
of the Act and Regulation before being sold
in the country.
7. Overview of regulatory process, 1 of 2
Appoint
Sponsor
Prepare
technical file
Classify your
device
8. Overview of regulatory process, 2 of 2
Submit
Manufacturer’s
Evidence
Submit
materials
Start
exporting!
Await review
completion
13. Australian Orthopedic Association
National Joint Replacement Registry
(AOANJRR)
• Funded Department of Health
• Data collection commenced Sept 1999
• Expanded to include shoulder, elbow, wrist, ankle and spinal
disc replacement 2007
• Objective “define, improve and maintain the quality of care of
individuals receiving joint replacement surgery”
17. Chinese market appeal
• Population of 1.4 billion.
• 2nd largest global economy.
• Device market totals $17.2 billion.
• Expected to grow 7.4% annually.
• China’s 13th Five-Year Plan will inspire
growth in the healthcare industry.
• 4th largest medical device market in the
world.*
* www.espicom.com
18. Chinese regulatory
process for medical devices
• Regulated by the China Food and Drug
Administration (CFDA), within the State Council
of the People’s Republic of China.
• First established in 1950 as State Food and
Drug Administration (SFDA), rebranded and
restructured in 2013 as the CFDA.
• Medical devices must meet the requirements
of Regulations for the Supervision and
Administration of Medical Devices (State Order
No. 650) before being sold in the country.
19. Overview of regulatory process, 1 of 2
Appoint
agent
Complete
testing
Prepare
technical file
Classify your
device
Submit QMS
certification
20. Overview of regulatory process, 2 of 2
Prepare
clinical
data
Submit
materials
Start
exporting!
Await review
completion
21. “Innovation product”
• No similar products have been registered in CFDA.
• Product is patented in China.
• Product is significant in clinical application or economic
aspects.
• Manufacturer has country of origin/home country approval.
• Applicant and CFDA appraiser will be permitted to meet and
discuss the product and application.
• CFDA regulatory review is expedited.
22. Clinical Evaluation (CFDA Order No. 4)
• Clinical Evaluation of devices exempted from clinical trial
– Clinical Trial Exemption Catalogs for Class II and Class III
• Clinical Evaluation through comparison with “equivalent
device”
– Comparison table with equivalent device legally marketed
in China
• Clinical Trial
Medical Device Registration Supervision, www.cfda.gov.cn/WS01/CL0053/103756.html
27. Indian market appeal
• Population of 1.2 billion.
• 9th largest global economy, about the same
as Italy.
• Device market totals $4 billion.
• Expected to grow 7.3% annually.
• Federal funding will bolster the healthcare
industry, despite declines in exports.
28. Indian Regulatory
Process for Medical Devices
• Regulated by the Drug Controller General of
India (DCGI), within the Central Drugs
Standard Control Organization (CDSCO).
• Legal framework for the regulatory system is
based on the Drugs and Cosmetics Act of
1940, and Drugs and Cosmetics Rules of
1945.
• A limited number of medical devices must
meet the requirements of the organization
before being sold in the country, including
orthopedic implants.
29. Overview of regulatory process, 1 of 2
Appoint
agent
Complete
testing
Compile
application
Does your
device
require
registration?
30. Overview of regulatory process, 2 of 2
Submit
application
Wait for
approval
Start
exporting!
Receive
certificate
31. Regulatory Strategy
• Legal and actual manufacturers need to be
reported to CDSCO, both included on the
Registration Certificate and labeling
• Actual manufacturer is site of “final batch
release”/QC of the medical device
• If legal is not actual, consider legal performing
final batch release/QC and issuing Certificate of
Analysis
http://www.cdsco.nic.in/writereaddata/FAQ-IMPORT-&-
REGISTRATION-02022013_DONEE.pdf
32. Registration Certificates Issued for Medical Devices, 2015
Legal Manufacturer: Stryker
Spine, USA
Actual Manufacturer: Stryker
SAS, France
http://www.cdsco.nic.in/writereaddata/mdRC_2015.pdf
http://www.cdsco.nic.in/Forms/list.aspx?lid=1758
33. SEC Orthopedic Meeting Outcomes
http://www.cdsco.nic.in/forms/list.aspx?lid=20
02&Id=32
Synopsis recommendations
from meeting 28 January 2015
37. South Korean market appeal
• Population of 50 million.
• 13th largest global economy, about the
same as Mexico.
• Device market totals $5.4 billion.
• Third largest medical device market in Asia
Pacific region.*
• Expected to grow 5.2% annually.
• Aging population and economic growth will
result in demands for better healthcare.
* www.espicom.com
38. South Korean regulatory
process for medical devices
• Regulated by the Ministry of Food and Drug
Safety (MFDS).
• Legal framework for the regulatory system is
based on the Medical Devices Act No.
13698.
• Medical devices must meet the requirements
of the Act before being sold in the country.
39. Overview of regulatory process, 1 of 2
Classify
your device
Appoint
license holder
Meet KGMP
requirements
Submit
testing data
40. Overview of regulatory process, 2 of 2
Prepare
submission
Submit
dossier
Wait for
approval
Start
exporting!
41. Clinical Evaluation (MFDS Notification No.
2015-114, Article 12)
• Data from institution designated by MFDS
• Foreign data performed according to KGCP and compliant to
SKR legislation
• Clinical trial data from OECD member country and reviewed
and approved trusted regulatory authority
• Data published journal academic society listed Science
Citation Index
• For Class I and Class II devices, acceptable to submit test
reports for equivalent devices
Approval, Notification and Review of Medical Devices, December 2015
47. Questions? Please contact:
Evangeline Loh, Ph.D., RAC
Vice President, Global Regulatory
Affairs
evangeline@emergogroup.com
Thank you for your attention
