Medical Device Regulations in the Middle East and North Africa

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

1-2 Jul 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 10 Apr

Book now

Course overview

The size of the medical device market in the Middle East has expanded over recent years and this trend is forecast to continue. The growth is due in part to innovations in technology as the majority of Middle Eastern countries are early adopters of technological advancement, which provides opportunities for medical device companies. The regulatory environment in the region is also developing and this annual seminar will provide an essential overview of the key requirements for product approvals for medical devices in the Middle East and North Africa.

The programme will focus on the regulatory requirements and developments in individual countries and include interactive discussion sessions to allow you to exchange experiences with our expert faculty and other delegates.

Benefits of attending:
  • Gain a valuable introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment
  • Familiarise yourself with medical device regulations in the countries of the Middle East and North Africa
  • Understand medical devices and their classification
  • Clarify procedures for company and product registration
  • Discuss recent developments in the region
  • Meet, network and share experiences with other industry colleagues

Book both

This meeting runs back-to-back with our Pharmaceutical Regulatory Affairs in the Middle East and there is a further £200/€280 discount when booked together.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend

The event will be of particular interest to:

  • Anyone involved in regulatory affairs for medical devices in the Middle East and North Africa
  • Anyone new to the region
  • Anyone interested in an update of recent developments

Programme

Covering regulatory affairs in:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

The medical device markets in the Middle East and North Africa (MENA)
  • Markets and culture
  • Healthcare
  • Business culture
  • Economic overview
  • Regulatory environment and characteristics
  • General regulatory requirements
  • Company and product registration
  • Key documents needed
  • Basic structure of a dossier
  • Regulatory summary
  • Country presentations
Medical Devices and their classification
  • What is a medical device
  • Different classes of products
Recent Developments in the Region
  • Harmonisation activities
  • Countries with new regulatory requirements for medical devices
  • Countries in the process of establishing regulatory guidance for obtaining marketing authorisations

Discussion sessions will take place throughout the two days

Presenters

Ilona Putz

Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East. She has worked in the pharmaceutical industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities.
She consults also for RegAff for the Middle East which is the only Global Specialist Regulatory Affairs company with a broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices. She spoke also for DIA (Drug Information Association) Switzerland on “Clinical Trials in the Middle East”, DIA Europe Meeting, Geneva 2011.

Heba Hashem

Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk.

Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies.

Book now

1-2 Jul 2020
1-2 Jul 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 10 Apr*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Beckman Coulter International SA
  • Biomet UK Healthcare Ltd
  • Biotronik AG
  • BSN medical GmbH
  • Coloplast A/S
  • CooperVision
  • DextReg
  • Ego Pharmaceuticals Pty Ltd
  • Fakhoury Medical Supplies Est - F.M.S.
  • Fresenius HemoCare Netherlands BV
  • Fujirebio-Europe NV
  • Ginsana SA
  • Horus Pharma
  • Hospira (ME & NA)
  • Institut Straumann AG
  • ISS AG, Integrated Scientific Services
  • Johnson & Johnson
  • Medtronic Ireland
  • Olympus KeyMed Ltd
  • Orthofix Srl
  • Pfizer Gulf FZ LLC
  • PHIBO Middle East
  • Saudi Food and Drug Authority
  • Septodont
  • Smiths Medical International Ltd
  • Sybermedica Ltd
  • TUV RheinlandInternational GmbH
  • Varian Medical Systems
  • Vertex-Dental B.V.
  • WEINMANN Emergency Medical Technology GmbH + Co. KG

Very good course, covered just enough to have a good overview in amount time given.

Agata Chmielewska, RA/QA Specialist, CooperVision

The speakers were really friendly and were able to answer questions from the listeners.

Jonas Friederich, Regulatory Affairs Manager , WEINMANN Emergency Medical Technology GmbH + Co. KG

The course was very informative and the booklet I can take home is fantastic to look back on when a query arises. The speakers were very informative and kept the course interesting.

Michelle Lord, RA Officer, Sinclair Pharma

Generally the content flowed well, but there was a couple occasions where the slides were changed a little too quickly...

Kelly Jeffs, Regulatory Affairs Specialist, CooperVision Manufacturing Ltd

It was good. The flow was very nice.

Stephanie de Souza, Regulatory Officer, Vertex-Dental B.V.

All great

Simona Fiori, Regulatory Market Specialist, Orthofix Srl

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd

Very good, covered many countries in a short time. Will recommend the course.

Manuela Müller-Maissen, Senior Regulatory Affairs Specialist, Varian Medical Systems

Very good presentations and binder

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS

I found the day engaging and helpful. The willingness from the speakers for us to learn was evident, and I appreciated that they asked from the beginning what our expectations were for the day, and aimed to meet these.

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Great day, informative and good interaction – would recommend

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA