This document provides an overview of the medical device regulatory and clinical environment in Israel. It discusses IQVIA's MedTech Regulatory Solutions group and their expertise in guiding clients through the medical device development and regulatory process. It then provides context on Israel's healthcare system, describing it as technologically advanced with a national health insurance program. The document outlines Israel's medical device law and registration process, noting requirements around clinical data, labeling, and changes. It also describes benefits of conducting clinical trials in Israel such as its skilled workforce and diverse population.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
C5 eCTD Summit: Electronic submissions and the new Variations Regulationseront
Managing and Publishing Electronic Submissions Following the New Variations Regulation (Worksharing and Grouping)
C5 eCTD Summit - September 2010 - Munich, Germany
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
C5 eCTD Summit: Electronic submissions and the new Variations Regulationseront
Managing and Publishing Electronic Submissions Following the New Variations Regulation (Worksharing and Grouping)
C5 eCTD Summit - September 2010 - Munich, Germany
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
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
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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/.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
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.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
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
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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/.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
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.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
Overview of the Israeli exhibitors at the 2023 HLTH conference in Las Vegas. Exhibitors included 6Degrees, AppScent, Belong.Life, Datos, Expecting, IntraPosition, Kahun Medical, Kemtai, Maverick, Neteera, QuantaIX, Respiration Scan, Nerivio, Xoltar.
40% of Israeli technology investment is devoted to Life Science. Within that domain, the largest sector is Medical Devices and Digital Health (over 65 percent of companies). In the medical device arena, Israeli scientists and engineers have integrated advanced technologies in electronics, communications and electro-optics to develop world-class innovations in Digital Imaging, Medical Lasers, Telemedicine, Early Diagnostics,
Smart Surgical Equipment and more. Over 600 medical device exporters engaged in a variety of medical application
such as Cardiovascular and Peripheral Vascular, Neurology and Degenerative Diseases, Preparedness and Emergency
Medicine, Intensive Care, Women Health, Orthopedics and Sport Medicine, Gastrointestinal, Infection Control, Ophthalmology, Pain and Wound Management, Oral and Dental Care, Dermatology and Aesthetics
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
Connected Medical Devices Market and Business Models 2017 Report by Yole Deve...Yole Developpement
The Internet of Medical Things (IoMT) powers industry momentum in digital health and reinvents healthcare organization.
CONNECTED MEDICAL DEVICES: THE DIGITAL HEALTH REVOLUTION HAS STARTED
Healthcare is facing one of its most major turning points in decades. After penetrating the consumer market, the digital revolution and its related concept of the Internet of Things (IoT) is rapidly changing health models. There are many reasons for this transformation. The population is growing and aging, and chronic diseases are exploding. More than 415 million people are living with diabetes worldwide and there are more than 1.5 billion people at risk of cardiovascular diseases. The number of doctors and nurses has stayed consistently flat, as health budgets are shrinking in many regions. Fortunately, connected devices and smartphones are now widespread. People are managing their lives through apps and clouds, and now can do the same with their health, from hospital to home or even just walking in the street. This report analyzes the dynamics of the connected medical devices market and how its current $9B revenues will grow at a rate of 16% year-over-year through to 2022 to reach more than $23B. Healthcare is shifting to a patientcentric model with nearly 20% growth over the period to 2022 for the segment of self-quantified devices. This compares to single-digit growth for connected implantable devices, which face serious security issues. Preventive and predictive medicine and even participative medicine are on the way to supplement evidence-based approaches, using the large volumes of data generated by these connected medical devices.
More information on that report at http://www.i-micronews.com/reports.html
A complete scenario of Medical Device Industry Of USA and India as well as of some major players. The presentation also highlights the Rules and regulations with respect to the devices and also SWOT analysis of emerging markets
Regulatory Affairs in the Pharmacy Curriulum A Reviewijtsrd
The Indian pharmaceutical industry is expanding quickly, and there is a need of regulatory affairs specialists to meet the present demands of companies in the face of international competition. The goal of governments to protect public health has led to the development of a relatively new profession known as regulatory affairs. Pharmaceuticals, veterinary medications, medical gadgets, pesticides, agrochemicals, and cosmetics are among the industries where the government regulates the safety and effectiveness of products. And alternative treatments. The pharmaceutical firms in charge of these drugs discovery, development, testing, clinical trials, production, manufacturing, and marketingItems also want to make sure that they are providing products that are secure and beneficial to the health and welfare of the general public. legislative issuesThe international regulatory bodies and the pharmaceutical businesses are connected via specialists. It is needed that they. Akshay Kaware | Prof. Santosh Waghmare | Dr. Hemant Kamble "Regulatory Affairs in the Pharmacy Curriulum: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52279.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/52279/regulatory-affairs-in-the-pharmacy-curriulum-a-review/akshay-kaware
New technologies and faster market launches are driving the medical wearables market.
More information on that report at: https://www.i-micronews.com/produit/medical-wearables-market-and-technology-trends-2019/
IMPACT OF APPLYING INTERNATIONAL QUALITY STANDARDS ON MEDICAL EQUIPMENT IN SA...ijcax
With the great development that, modern medical technology is witnessing today, medical devices and
equipment have become a basic pillar of any healthcare system in the world and cannot be dispensed with,
so we find competition between the major companies that manufacture medical devices and equipment
resulting in a huge variety of complex modern medical technologies. These medical devices and equipment
require high accuracy in manufacturing and packaging in addition to operation, maintenance, and followup, because any error in any of the previous stages will have bad consequences for the patients and the
health system, there are many accidents that have led to some deaths. Therefore, we find that many medical
device producers and medical companies in addition to health service providers seek to find systems and
protocols to reduce accidents resulting from medical devices. As a result, many systems have recently
appeared that seek to protect from the dangers of medical devices and equipment. This research aims to
conduct a study of the effects of international standards on the safety of medical devices and equipment
and reduce their risks. By counting the international standards in force in the Kingdom of Saudi Arabia
that are applied by the Saudi Food and Drug Authority, making questionnaires, and distributing them to
health service providers and regulatory bodies for medical devices and equipment, considering the data,
these data will be analysed and evaluated the effectiveness of quality systems and standards in maintaining
Effectiveness and quality of medical devices and equipment. The study will include governmental and
private health services sectors.
Israel medical devices industry - Market OverviewMeidata
Comprehensive overview of the medical devices industry in Israel.
Israel is well known for its innovative medical devices industry and despite the unfavorable global economic climate this sector has been steadily growing. As of August 2012, there are 656 medical devices companies in Israel which constitute around 60% of the entire life sciences industry. It should be noted, however, that medical devices companies are typically very small and in Israel over 50% of all companies are based on only 5 employees or less. Only 19 companies employ over 100 workers. Most of the companies, almost 70%, have not yet reached the commercial stage and are still at various stages of their product development.
The Israeli medical devices sector consists of 9 sub-sectors, the biggest of which is therapeutics (225 companies) followed by the monitoring & diagnostics sub-sector (141 companies). The most dominant sub-sector in terms of successful companies and advanced stage companies is the imaging sub-sector. This sector includes one of Israel's well-known and successful medical devices company – Given Imaging. The telemedicine sub-sector, while young, holds a great promise as will be further explained in this research.
After a sharp drop in exports following the economic downturn in 2008, exports of medical devices has been steadily growing during the last years. In 2011 Israel exported over $1.6 billion worth of medical devices mainly to the US, Japan, China and Europe.
The medical devices sector has always held a high risk for investors. Lately, this risk has grown due to uncertainty as to the future economic climate, more stringent regulation (by the FDA) and price pressures. Due to the fact that the US is the largest market for medical devices, FDA marketing approval is vitally important for medical devices companies. The fact that these approvals have become more difficult to obtain, deters some investors from investing before a company overcomes the regulatory hurdle. Generally, these risks are making investors more cautious and less likely to invest in early stage companies. This means that many companies will not make it to the finish line, not necessarily because their products are not good enough but because they do not have enough funds to see it through.
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...Greenlight Guru
The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle.
How Electronic Data Capture Is Transforming the MedTech IndustryGreenlight Guru
Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more!
The ROI of Shifting Mindset From Compliance to QualityGreenlight Guru
Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization.
Leveraging Modern Software Technologies: MedTech’s Best Kept SecretGreenlight Guru
There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS.
Behind the Stats: Expectations vs. Reality of Bringing a Device to MarketGreenlight Guru
Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond.
Common Misconceptions on Medical Device Risk & Design ControlsGreenlight Guru
Learn about common misconceptions on medical device risk and design controls.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
QMSR Harmonization: The Future of FDA's Quality Management System RegulationGreenlight Guru
Learn about the future of FDA's Quality Management System regulation.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Modernizing your QMS to keep up with the Modern Age of RequirementsGreenlight Guru
Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Moving up to the State of the Art in Risk ManagementGreenlight Guru
During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...Greenlight Guru
The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Reducing Friction Between Companies and Regulatory BodiesGreenlight Guru
We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Latin American Regulations - What you Don't KnowGreenlight Guru
Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
The Global Guide to Human Factors and Usability Engineering RegulationsGreenlight Guru
The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
QMSR Harmonization - The Good the Bad and the UglyGreenlight Guru
Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more!
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
2. 1
Insights on the MedTech Regulatory and Clinical Environment in Israel
Who we are and what we do
Israel at a glance
The healthcare and medical device system in Israel
Regulatory requirements and market access
Clinical trials in Israel
3. 2
Who we are
MedTech Regulatory Solutions, Europe
Pragmatism
Business-driven
Customer focused
All device types
from home to
hospital use
Low to high risk
Small start-ups
Large multi-
nationals
• Team of dedicated Regulatory, Clinical and Quality
professionals, with extensive background in engineering
and life-sciences, experienced with a wide range of medical
device technologies
• Have the expertise to guide clients through the entire
development process, from initial concept to regulatory
plan, verification and validation, clinical studies, pre-
marketing clearance and post-marketing compliance.
• We know how to get products past the regulatory hurdles
by providing pragmatic and creative solutions
• We understand the needs of the vibrant high-tech medical
device industry and the dynamic regulatory environment
• Committed to helping clients market better products faster
• Over 3,000 clients served since 1989
4. 3
Breakthrough
Technologies
In Vitro Diagnostics
/ Companion
Diagnostics (DCx)
Combination Products
(Device)
Diagnostic,
Therapeutic, and
Monitoring Devices
Electro-mechanical s/w
controlled devices
What we do
MedTech Regulatory Solutions, Europe
Europe
Interactions and communication with European health authorities, Notified Bodies and
Competent Authorities, change notifications, vigilance reporting and handling
FSN/FSCA and recalls.
Regulatory strategy development, definition of product-related standards, periodical
standards review (gap analysis and impact analysis ) and regulatory due diligence for
M&A.
Device classification and pathway, DHF / DMR evaluation and gap analyses.
Preparation of Technical Files/Documentation and dossiers for CE Mark according to
MDD/AIMD/IVDD and MDR/IVDR.
Risk Management consultation, planning, FMEA/FMECA reports, Usability plans and
reports.
Preparation of V&V plans and reports.
Preparation of audit plans, first and second party QMS and regulatory audits, product
and process audits, participation in audits made by regulatory authorities and
evaluation and approval of sub-contractors.
Post-market Regulatory Submission and surveillance.
Ad hoc consultancy services and training.
Software Apps,
Wearables, Bluetooth-
enabled
Active / non-active
Implantables
5. 4
Eng. Adi Ickowicz
Senior Principal, MedTech Regulatory Solutions, Europe
Current responsibility
• Assist clients define and execute regulatory and clinical pathways and strategies for
Europe to meet technical and regulatory requirement for different products and
technologies, communication with European certification bodies (e.g. NBs, CAs)
• Assists clients with product development and manufacturing planning. Define product
related standards
• Conducts assessments, e.g., due diligence evaluations, product and process audits, QMS
audits and evaluation of suppliers and sub-contractors
Profile overview
• Brings over 25 years of MedTech experience in regulatory,
clinical and quality of medical devices and product and
process management
• Prior experience includes:
• Founder and CEO of MedicSense Ltd. A regulatory and
clinical affairs medical device consultancy firm.
• Working with different medical device SMEs in various
positions (e.g. Odin, Sharplan)
• Senior Principal in IQVIA since 2019
Education
• B.Sc. Mechanical Engineering, BGU University of Israel
• Weizmann Institute of Science, Israel
• BSI Certified Lead Auditor for ISO13485, ISO27001 and
ISO27799
Areas of expertise
• Commercialization of Innovative
Technologies:
• Active and non active medical
devices including digital health and
SaMD (Software as Medical Devices)
• Combination Products
• Active Implantable Medical Devices
Relevant experience
• Marketing applications for different
types of medical devices, combination
products – device constituent part
• Innovative software-driven medical
devices / SaMD
Biographies
6. 5
Insights on the MedTech Regulatory and Clinical Environment in Israel
Who we are and what we do
Israel at a glance
The healthcare and medical device eco-system in Israel
Regulatory requirements and market access
Clinical trials in Israel
10. 9
Israel is a Member of the OECD world’s most
advanced countries organization, since 2010
Organization for Economic Co-operation and Development (OECD)
Israel at a glance
11. 10
Ref. The Economist 2015
20
Business Environment Ranking
Israel at a glance
Ref.: The Economist 2015
12. 11
Ref. The Economist 2015
Governmental investment in R&D
Israel at a glance
Ref.: UNESCO 2018
4.3% percentage of GDP
30% of the R&D budget is
devoted to life sciences
14. 13
• 4,000 registered Hi-Tech companies (it is estimated that there are additional
2,000 non-registered Hi-Tech companies)
• 500 companies with annual revenue exceeding 20 MUSD
• 600 new start-ups every year
• Over 400 Israeli subsidiaries or headquarters in the US
• Over 80 fortune 500 corporations conduct R&D in Israel
Ref.: Central Statistics Bureau of Israel, 2020
Hi-Tech i Industry in Israel
Israel at a glance
15. 14
World's highest number of scientists per capita
• More than 25% of Israel’s total work force hold university degrees
• 12% hold advanced degrees
Ref.: Central Statistics Bureau of Israel, 2020
Hi-Tech Industry in Israel
Israel at a glance
The top 10 most innovative countries, based on
the number of patents issued per capita:
1. Taiwan
2. Israel
3. United States
4. South Korea
5. Japan
6. Switzerland
7. Denmark
8. Sweden
9. Finland
10. Germany
USPTO 2019
Third in number of companies per capita listed on the
NASDAQ after USA and China
The Telegraph, Sept. 2016
16. 15
Israel’s economic achievements rely on Israel’s
ability to tap into its available scientific and
technological potential
start-up nation
Israel at a glance
Hi-Tech Industry in Israel
17. 16
Insights on the MedTech Regulatory and Clinical Environment in Israel
Who we are and what we do
Israel at a glance
The healthcare and medical device eco-system in Israel
Regulatory requirements and market access
Clinical trials in Israel
18. 17
The healthcare and medical device eco-system in Israel
Israel and the medical/science industry
1,600 registered medical
device companies
Ref.: Central Statistics Bureau of Israel, 2021
19. 18
• Every resident of Israel is insured for healthcare under the National Health Insurance
Law.
• Every resident can choose one of the four health plans (Clalit, Leumit, Maccabi and
Meuhedet) regardless of age, pre-existing condition(s) or state of health
• The plans provide an identical basic basket of services, including doctor visits,
diagnostic and laboratory services, hospitalization including births and discounts on
prescription medications.
• Israel has a technologically advanced and highest-quality healthcare systems.
Hospitals are equipped with modern facilities and high-quality medical technology.
• Israel is a leading country in medical tourism
The healthcare and medical device eco-system in Israel
The healthcare system in Israel
20. 19
September 19, 2018
The healthcare and medical device eco-system in Israel
The healthcare system in Israel
21. 20
Insights on the MedTech Regulatory and Clinical Environment in Israel
Who we are and what we do
Israel at a glance
The healthcare and medical device eco-system in Israel
Regulatory requirements and market access
Clinical trials in Israel
22. 21
Regulatory requirements and market access
The Ministry of
Health is
responsible for
the regulation
of medical
devices in
Israel.
All companies (including
importers) wishing to
import medical equipment
or devices must be listed
with the Ministry of Health
Foreign manufacturers who
are willing to export their
devices in Israel shall
appoint a local agent or
distributor
www.gov.il/en/departments/ministry_of_health
23. 22
For the healthcare authorities
Formalize and Harmonize the requirements
For the medical device industry
The new Israeli Medical Device Law 2012 (LVB 2357/394) dated May 14, 2012
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
24. 23
Scope of Legislation:
• According to the new Israeli Medical Device Law Medical Devices manufactured or
marketed in Israel must be registered by the Ministry of Health registrar (AMAR - The
Medical Device Division of the Israeli Ministry of Health).
• Applications for registration must be done only by an Israeli citizen or by a corporate
entity established in Israel.
• Registration can be done by an independent body a.k.a the “Israeli Registration
Holder” (IRH) or by the manufacturer's distributor.
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
25. 24
Product Registration:
• The regulatory system fully accepts regulatory approvals from the US FDA, EU CE,
Canada, Japan, NZ and Australia by providing evidences that the device was
cleared/approved/listed.
• The application shall be submitted to the Medical Device (AMAR) division (in Hebrew
or in English).
• There is no classification system in place, the classification is according to the
regulatory systems in the recognized geographies described above. In case of conflict
the FDA classification will be considered.
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
US FDA
EU CE
26. 25
Product Registration Process:
The instructions for the preparation of the registration
application and the list of required documentation/information
are provided by the "Application instructions" by the medical
device division (AMAR) which is only provided in Hebrew.
The information is published at the MoH website
http://www.health.gov.il/
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
27. 26
Labeling and language requirements:
• The IFU for home use products must be translated into Hebrew and Arabic.
• The User Interface for home use products must be translated into Hebrew.
• Devices to be used in a hospital or clinic setting may have an interface and GUI
in English.
• Information of the registration holder must appear on the labels and IFU.
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
28. 27
Clinical Studies:
If the device is Class IIb or above in the EU or Class II in the US,
or above a clinical evaluation summary or clinical trial summary
and risk management summary must be submitted.
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
29. 28
Estimated timeline and costs:
Review timeframe is approximately 4-6 months. The current
registration fee is approximately 1200* ILS/device registration
(approx. 350 USD).
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
* The MoH is about to cancel the fee
30. 29
Change notification:
The medical device division (AMAR) must be notified of any major
changes, including:
1. changes in indication for use and fundamental technology or
reregistration that are associated with FDA, CE or ISO certifications
2. changes with impact on the Fit, Form and Function (FFF) of the
device.
3. Any significant change considered as such by the US FDA or EU NB
In addition, adverse events that occurred in Israel or other countries
where the same product is marketed shall be reported
The healthcare and medical device eco-system in Israel
The new medical device law in Israel, 2012
31. 30
The Israeli Registration Holder (IRH)
According to section 3(d) of the new law, the submission to the
medical device division (AMAR) can be done through a professional
and skilled third party. The holder of the Registration (IRH) is
responsible for the liaison with the medical device division (AMAR)
The healthcare and medical device eco-system in Israel
The Israeli Registration Holder (IRH)
32. 31
The Israeli Registration Holder (IRH) is responsible:
1. Reside and maintain a place of business in Israel and serve as the regulatory representative
(section 3(b)).
2. Prepare and submit the registration application to the AMAR Division (section 3(b))
3. Review the first batch of devices to be marketed in Israel as requested by the AMAR Division
(section 7(a)1).
4. Liaise and respond to questions from the AMAR Division concerning the registered product(s)
(section 15(b)).
5. Report of adverse events to the AMAR Division (section 15(b)).
6. Renew your registration on time to maintain the market approval active (section 8)
7. PMS and Vigilance, including evaluation of information provided by users, periodical reports
(upon request), report of adverse and unexpected incidents occurred in Israel or other
countries etc. (section 11).
The healthcare and medical device eco-system in Israel
The Israeli Registration Holder (IRH)
33. 32
The “Israeli Registration Holder” (IRH) mechanism of liaison with
the authorities reminds the European Authorized Representative
(EAR) and the FDA US Agent roles
The healthcare and medical device eco-system in Israel
The Israeli Registration Holder (IRH)
The Registration Holder is responsible and liable like he was the
legal manufacturer
34. 33
Insights on the MedTech Regulatory and Clinical Environment in Israel
Who we are and what we do
Israel at a glance
The healthcare and medical device eco-system in Israel
Regulatory requirements and market access
Clinical trials in Israel
36. 35
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Mutual
recognition
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
Israel is a listed country
according to FDA’s Section
802(b)(1)(A) of the Act together
with: Australia, Canada, Japan,
New Zealand, Switzerland, South
Africa, or any member nation in
the European Union or the
European Economic Area
37. 36
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Accessibility
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
The country is 550 km long and
up to 50 km wide
Ø Rapidly recruiting
Ø Rapidly access to sites
38. 37
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Israel has one of the world's
most skilled and educated
work forces, with more
doctors, scientists and
engineers per capital than
any other nation
Skilled and
highly
educated work
force
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
39. 38
The healthcare and medical device eco-system in Israel
Population
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
Ø Israel population is heterogenic,
the population originates from
many countries and ethnicities
Ø All citizens carry an identity card
Clinical trials in Israel
40. 39
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
Efficient
national health
insurance
program
Ø Every resident of Israel is
insured for healthcare under the
National Health Insurance Law
Ø Every resident can choose one
of the four health plans
regardless of age, pre-existing
condition(s) or state of health
41. 40
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Infrastructure
Ø Israel has a technologically
advanced and highest-quality
healthcare systems. Hospitals are
equipped with modern facilities and
high-quality medical technology
Ø Most of the medical policies in
place are similar to those in the US
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
42. 41
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Attitude
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:
Ø Openness for new developments
Ø Israel is a leading country in medical
tourism
45. 44
Israeli public health regulations on clinical trials
involving human subjects were published in 1980
revised in 2006 and incorporate the principles of the
Declaration of Helsinki and ISO14155
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Principles
46. 45
Ø A clinical study on humans may not be carried out in Israel unless it conforms to the instructions of the
public health regulations and guidelines for the conduct of clinical studies on human subjects
Ø The clinical study must be approved by both the medical institute’s Ethics Committee / IRB (a.k.a.
Helsinki committee) and by the general director of the MOH or his authorization, as detailed below
Ø Only a licensed physician or licensed dentist in Israel (depending on the subject of the trial) can act as
the principal investigator (PI) and may submit a request for clinical study approval
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Principles
47. 46
• The clinical Investigation plan (CIP) study protocol
• The investigator’s brochure (IB), shall include safety information, i.e electrical safety, EMC, biocomp.
sterilization validation etc.
• The In formed Consent Form (ICF) must be officially in Hebrew according to the template provided by the
MOH and translated to the various spoken languages in Israel, i.e., English, Arabic, Russian, Amharic as
needed
• Labeling (Instruction for use)
• US National Institutes of Health (NIH) reporting approval
• Application forms
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Contents of the submission
48. 47
The Ethics Committee / IRB reviews the submission package
and determines whether or not to approve the study
and
determines whether or not the clinical study falls under the definition
of a “special” clinical study with a recognized study device
A “special” clinical study is one whose final approval is under
the authorization of the medical institution’s director
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
49. 48
Recognized study device:
Medical devices that satisfies any of the following criteria:
(a) Found in routine medical use
(b) Approved for marketing by the US FDA and sold in the
United States
(c) Approved for marketing and sold in a member state of
the EU (CE marked)
The healthcare and medical device eco-system in Israel
Clinical trials in Israel
Special clinical trials, the following criteria are met:
• Compliance with all the relevant safety standards applicable to a device of the same type
• Previous safety clinical trials been completed in a recognized country and their results are reported in
the protocol and IB
• The study involves a method of use applied in previous trials
• The study does not involve a special population
Special population means
pregnant women, minors under the age of 18th,
patients whose judgment has been impaired by their
physical or mental condition and individuals in legal
custody
50. 49
Non-special clinical trial:
A clinical trial that requires approval by the Ministry of Health (MOH) following approval
by the Institutional Ethics Committee
The healthcare and medical device eco-system in Israel
Clinical trials in Israel