Medical Device Import & Export to Israel

Fostering Growth: 

    Your Gateway to Import & Register Medical Devices & E-Health Services in Israel’s Flourishing Market

Why you should work with us?

Part of our Israeli markets Bio-Med Industries consulting services

Regulation

Navigating Israel's Medical Device Regulations

Seasoned experts in Medical Device & E-Health regulations, harmonizing your product with the Israeli Ministry of Health standards & Israeli legal nuances for market success

Eran Yona - Confidentiality

Confidentiality

Confidential, Reliable, Ethical:
Our Commitment

Trust our unwavering commitment to confidentiality, reliability & strict conflict-of-interest avoidance, safeguarding your
Bio-Med business interests with integrity

Eran Yona - Business Orientation

Service oriented

Our client-centered approach ensures ongoing success

Client-focused approach, continuous support:
Your success is the Israeli market is our mission. Partner with us for ongoing excellence in Medical Device & E-Health operations

Eran Yona - Global Network

Experience

Decades of Dedication, Countless Bio-Med Success Stories

Over two decades of expertise, serving a global network 1000+ Medical Device, Pharma & E-Health clients.
Trust our experience for your product's success in the Israeli markets

What we offer our Medical Device customers?

Technical File Preparation & Submission

♣ Technical File & Regulation consultancy

♣ Classification of the device based on the IMOH Requirements

♣ Sharing with you all relevant regulatory requirements checklist

♣ Documents, studies Reports & Certifications review

♣ Technical file gap assessment

♣ Gap assessment completion

♣ Technical file Re-arrangement according to the IMOH Requirements

♣ Forms Filling & Declarations approvals

♣ Submission in the IMOH AMAR Division

♣ Labels, Packaging  & Leaflets design based on the IMOH Regulations

For Device registration

Importing & Distribution

♣ Medical device importing licensing

♣ Import/Export documentation assistance

♣ Product localization

♣ Customs Clearance services

♣ Supply Chain management

♣ Logistics &Shipping coordination

♣ Environmental controlled & Validated storage services

♣ Environmental controlled & Validated Distribution services

♣ Adverse events report to AMAR in accordance with regulations

♣ Device registration renewals applications

♣ Intermediary for Receiving & Submitting documents to AMAR

♣ Post-Market Surveillance in compliance with regulations

♣ Consulting & advisory Services

♣ On-site device technical support & maintenance

For Importing & Distributing

Marketing

♣ DRG Services

♣ Accessibility to all Hospitals & Clinics in Israel

♣ Identifying & engaging with Key Opinion Leaders

♣ Market access consulting, Market Research & Analysis

♣ Marketing Collateral Creation

♣ Healthcare Professional Training

♣ Distribution Network Establishment

♣ Clinical Trials & Studies

♣ Assistance with local medical device trade shows

♣ B2C Marketing platforms

♣ Participation & Support in business meetings

For Marketing
Eran Yona bio-chem

Hello, I’m Eran –

As an industry expert in the field of Bio-Pharma and Medical Devices based in Tel Aviv, I am the CEO of Bio-Chem Ltd (2007).

With over two decades of diverse experience, I have successfully guided more than 1,000 global Bio-Med clients through the entire journey – from product development to regulatory approval, importation, marketing & distribution

What value my clients receive?

I hired Eran's consultant services for several projects while working as QA manager in the pharmacy services at Sheba Medical Center in robotics, software and clean rooms validation. Each of the projects was professionally and cooperatively managed all through the project. The inputs and the knowledge that we have earned while working with Biochem improved performances and promoted us towards regulatory approvals.
Shirly Rosenstadt-Nevo recommends Eran Yona
Shirly Rosenstadt-NevoQA Supervisor at Curetech
Eran Yona has many years of experience in industrial pharmaceuticals from design to GMP manufacturing.
I was very satisfied with his recommendations and practical suggestions.
Adrian Harel
Dr. Adrian HarelCEO - Medicortex
I found Eran to be professional in my interactions with him and responsive to my inquiries.
I would definitely partner with Eran again and I highly recommend his services.
Lars NageraSenior Manager - Giliad
Eran served both as a mentor and also supported directly different critical activities.
Eran provided high-quality performance and documentation with complete accountability to time and budget.
Yaki Sidis
Yaki SidisGeneral Manager - Omrix J&J
Eran, thank you for the quality of service provided. We sincerely appreciate your efficient, gracious customer service, the level of detail and accountability.
Shiri Menachemi
Shiri MenachemiExecutive operations manager - Emedgene
We meet many people throughout our careers, but only some leave the marks, and one of them is Eran.
I would recommend contacting Eran and being sure this is the right choice.
Ofer Alexander
Ofer AlexanderManaging director - Medimor medical
Eran was very professional and instrumental and was doing all that with a smile, even after long (sometimes very long) work hours and facing non-trivial challenges.
Dr. Dan Goldstaub
Dr. Dan GoldstaubManaging director - MSD
I enjoyed working with Eran.
He performed excellent professional work with defined and well-written study plans, delivering the required services in several pharmaceutical development projects on time.
Dr. Shimon AmsalemChief Scientist & Technology - ADAMA
Eran Yona supported me throughout the entire project. He was task-oriented and committed to project timelines, pleasant to work with, and very professional.
I can warmly recommend Eran Yona for global industry consultancy.
Yaron HaitovichProjects manager
Eran Yona was professional and service-oriented throughout the entire project.
He supported us to complete the project on time and successfully.
Inbal Kapry
Inbal KapryEngineering & QA manager - Merck
II would greatly like to recommend Eran Yona.
He was very dedicated, very professional, work very quickly and was also very pleasant to work with.
Dr. Roni Attali
Dr. Roni AttaliSenior director - Aidoc medical
Eran was very professional, well-skilled, and experienced, and the inspection was thorough and efficient. Thank you!
Dr. Gali Guzikevich
Dr. Gali GuzikevichSenior Director R&D Lab Manager - Teva
Eran is great to work with.
He is reliable and very knowledgeable in almost all the aspects of pharma, biotechnology and medical device.
Stephen Shattenstein
Stephen ShattensteinQA manager
Many thanks to Eran Yona.
The job was completed professionally although the very tight timelines. Eran was very pleasant and kind.
I would be happy to recommend Eran’s consulting services.
Simcha VasanaQA manager - Phibro
Thank you Eran.
Working with you was very professional and efficient. You were pleasant and kind throughout the entire project.
I Thank you for your support and will be happy to recommend you for your excellence and professional consulting service.
Dr. Yael KoreshQA manager - Minipack
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Few of the companies I worked alongside with

OPKO Logo
Johnson and Johnson Logo
TevaPharm Logo
MEDTRONIC Logo
MERCK Logo
WEST Logo
SGS Logo
FERRING Logo
GILEAD Logo
Sartorius Logo
PHILIPS Logo
MONSANTO Logo
Depomed Logo
KAMADA Logo

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