Insights on the MedTech Regulatory and Clinical Environment in Israel
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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.
Insights on the MedTech Regulatory and Clinical Environment in Israel
- 1. Copyright © 2019 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries. Virtual Event, September 1st, 2022 Insights on the MedTech Regulatory and Clinical Environment in Israel Eng. Adi Ickowicz Senior Principal, MedTech Regulatory Europe
- 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
- 7. 6 Population Israel at a glance Ref,: UN Statistics, total population by country 2022
- 8. 7 Israel is ~473 times smaller than the United States Size of country Israel at a glance
- 9. 8 Ref.: International Monetary Fund (October 2021) Gross Domestic Product (GDP) per capita Israel at a glance
- 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
- 13. 12 medical/science software telecom Hi-Tech Industry in Israel Israel at a glance
- 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
- 35. 34 Accessibility Skilled and highly educated work force Mutual recognition Infrastructure Attitude Population Efficient national health insurance program 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:
- 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
- 43. 42 The healthcare and medical device eco-system in Israel Clinical trials in Israel
- 44. 43 The healthcare and medical device eco-system in Israel Clinical trials in Israel
- 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
- 51. 50 The healthcare and medical device eco-system in Israel Clinical trials in Israel
- 52. 51 The healthcare and medical device eco-system in Israel Clinical trials in Israel Typical timelines
- 53. Contact: Adi Ickowicz Senior Principal MedTech Regulatory Solutions, Europe Tel: +972 52 3753829 adi.Ickowicz@iqvia.com MedTech Regulatory Solutions, Europe THANK YOU !!!