Our Services : IRH Services Israel, Business Development Israel & Europe- MD Field, Allocation of your MD Distributor/s in Israel- Market Research & Penetration 15 years of experience MD Field

Why do you need RA & Business Experts in Medical Device Field?Advantages!!!

Preparing a dossier for submission of Medical Devices in general and in Israel, is a professional field .

L.S.Marketing & Registration is one of the biggest Registration &Marketing /Business Development companies

Our 15 years of Experience MD Field : Business Development Israel & Europe- MD Field Very good contacts with the biggest partners of the biggest Israeli Drug Stores Israeli MOH Registration of Medical Devices- 15 years of Experience preparing

the dossier and submission+ follow up w/ MOH Israel – doing all needed actions for a final approval.

We have approx 150 customers/ contacts in MD Field- Medical companies/ Cosmetics/Drugs .

Why do you need an RA Expert ?

RA Experts – know on what to focus …

Preparing the dossier with all needed docs /approvals, know what will be checked by MoH.

Cost & time effective process by a professional , will save you the “headache” of bureaucracy.

15 years of experience with all MoH regulations

What is a Medical Device?

A Medical Device is according to Directive (93/42/EEC) : Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease.

In Vitro Diagnostic Medical Device (IVD)-Directive (98/79/EC)

Any medical device which is a reagent, reagent product, calibrator etc. which are used in Labs , and are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

Active Implantable Medical Device (AIMD) - Directive (90/383/EEC

Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure".

What is Amar?Taken from new Israeli MD Law

A Medical Device will be registered in Israel by an Israeli citizen or by a corporation registered in Israel- Israeli Registration Holder.

The validity of the registration in the Register will be determined according to various Registration Periods of the approvals – CE , ISO1345, FDA 510K etc..

Amar – The registration of MD in Israel is acc. to the EU Directive and /or the FDA , Canada , Australia , actually according to the relevant recognized countries by MOH.

Recognized countries are as follows:

Austria, Australia , Italy,Island ,Ireland, USA, Belgium, UK, Germany, Denmark, Holland ,Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden, Switzerland.

Import License of Medical Devices A yearly Import License will be given to the importer only after a full

submission of the MD he wants to sell in Israel.An Israeli Importer can not sell the products w/o a registration in the

Register of MoH Israel.

Medical Devices which not always need registration in Israel are the following:

Providing essential Medical CareResearchDevelopment & Production excluding marketingMedical Devices Use in Emergency statusA Medical Device for export aloneClinical Evaluation Personal Use

What is the connection between ISO9001 , ISO13485 & Amar?

According to the new Israeli Medical Law , all importers need to have ISO9001 & all Israeli manufacturers ISO13485.

Registration in Israel- can be done only for 1 technical family of products per dossier , with same risk class. How to check??? Answer: Indication ForUse

For registration in Israel , manufacturers/ Suppliers worldwide - need to show ISO 13485 and CE for class I sterile, Im ,IIa, IIB,III devices

Distributors - at least ISO 9001 Up to 3 manufacturing sites per dossier

Separation of dossiers according to : Sterile and not sterile products implants , unless they are included in 1 system Different Classes – Risk levels of products , unless various classes are 1 system

+accessories Biological and non biological products OTC & Professional Devices etc.

IRH Services – Israeli Registration Holder

1st IRH – Israeli Registration Holder Services for MD Field – We will open the doors for you to the Israeli Market – there are 2 options : A big advantage in case that you do not want to appoint a specific distributor in

Israel. We will register your products in the Israeli MOH , will make the follow up with MOH and will be your RA Rep. in Israel. We will update MOH concerning all regulatory issues incl. recalls.

Or : Allocation of your MD Distributor/s in Israel- Market Research & Penetration

Services in Israel – 15 years of experience MD Field . Thanks to our wide connections in the Israeli MD Field, we can help you to find

the right distributor/s. We will check the distributor for you , we will make a market research if needed.

Why us? Our Team: A multicultural , multilingual team – speak German,

English, French, Hebrew . Worldwide connections , especially with Europe / Germany . We bring our knowledge and experience in Registration, Marketing, Business Development & Logistics in MD Field, having local wide connections in Israel, with flexible , professional actions , believe in close partnership, and have a short decisions process.

L.S.Marketing & Registration –More Services

Import –Export Services – 15 years of experience – helping you to import your products to Israel & register them in Israel

EU Rep services - we will help you and connect you w/ EU Rep and will open you the ways to EU market

OEM services in Germany and a close partnership w/ a sterilization& logistics site in Europe – sterilization, packing, shipment to customers all in 1 bundle.

Preparing companies to ISO9001 -13485 ,CE Audits , preparing CE technical dossier

L.S.Marketing & Registration

For more information , pls. do not hesitate to contact us:

Liat Nadel, Shuky Nadel- OwnersMobile: 00972- 54-8058871 00972-52-3516078Website :www.ls-amarandmore.com Thank you ! “All Rights Reserved” L.S.Marketing & Registration