Insights on the MedTech Regulatory and Clinical Environment in Israel

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Virtual Event, September 1st, 2022
Insights on the MedTech Regulatory and
Clinical Environment in Israel
Eng. Adi Ickowicz
Senior Principal, MedTech Regulatory Europe

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

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

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
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

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

5
Israel at a glance
The healthcare and medical device eco-system in Israel

6
Population
Israel at a glance
Ref,: UN Statistics, total population by country 2022

7
Israel is ~473 times smaller than the United States
Size of country
Israel at a glance

8
Ref.: International Monetary Fund (October 2021)
Gross Domestic Product (GDP) per capita
Israel at a glance

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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

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Ref. The Economist 2015
20
Business Environment Ranking
Israel at a glance
Ref.: The Economist 2015

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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

12
medical/science
software
telecom
Hi-Tech Industry in Israel
Israel at a glance

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• 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

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
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

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

16
Israel at a glance

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Israel and the medical/science industry
1,600 registered medical
device companies

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• 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 system in Israel

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September 19, 2018
The healthcare system in Israel

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Israel at a glance

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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

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 new medical device law in Israel, 2012

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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.

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.
US FDA
EU CE

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/

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.

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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.

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 MoH is about to cancel the fee

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

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)

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).

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The “Israeli Registration Holder” (IRH) mechanism of liaison with
the authorities reminds the European Authorized Representative
(EAR) and the FDA US Agent roles
The Registration Holder is responsible and liable like he was the
legal manufacturer

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Israel at a glance

34
Accessibility
Skilled and
highly
educated work
force
Mutual
recognition
Infrastructure
Attitude
Population
Efficient
national health
insurance
program
Among the reasons cited by international
companies for carrying out clinical trials in
Israel are:

35
Mutual
recognition
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

36
Accessibility
Israel are:
The country is 550 km long and
up to 50 km wide
Ø Rapidly recruiting
Ø Rapidly access to sites

37
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
Israel are:

38
Population
Israel are:
Ø Israel population is heterogenic,
the population originates from
many countries and ethnicities
Ø All citizens carry an identity card

39
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

40
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
Israel are:

41
Attitude
Israel are:
Ø Openness for new developments
Ø Israel is a leading country in medical
tourism

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43

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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
Principles

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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
Principles

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• 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
Contents of the submission

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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

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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)
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

49
Non-special clinical trial:
A clinical trial that requires approval by the Ministry of Health (MOH) following approval
by the Institutional Ethics Committee

50

51
Typical timelines

Contact:
Adi Ickowicz
Senior Principal
Tel: +972 52 3753829
adi.Ickowicz@iqvia.com
MedTech Regulatory Solutions,
Europe
THANK YOU !!!

Insights on the MedTech Regulatory and Clinical Environment in Israel

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