Presented by
Management Forum
Medical Device Regulations in the Middle East and North Africa Training Course
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
★★★★★ "Very good course, covered just enough to have a good overview in amount time given."
15-16 Jun 2022 + 2 more dates
- Format: Live online, Classroom
- CPD: 12 hours for your records
- Certificate of completion
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
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
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
- What is a medical device
- Different classes of products
Individual Country Presentations:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
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
The Medical Device Regulations in the Middle East and North Africa course will cover:
Economic Overview
Saudi Arabia
GCC Prequalification GPP
Kuwait
Bahrain
Oman
Yemen
UAE
Iran
Eygpt
Algeria
Morocco
Tunisia
Israel
Palestine
Syria
Jordan
Lebanon
Iraq
Sudan
Medical Device Network
Ilona Putz
Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international manufacturers in the healthcare sector across the Middle East. Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she was the Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She also consults for RegAff, Emergo and Dr. Regenold GmbH for the Middle East. Ilona spoke during the DIA Europe Meeting on “Clinical Trials in the Middle East” and at the Global Pharmaceutical Regulatory Affairs Summit 2021.
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 Medical Device Regulations in the Middle East and North Africa Live online/Classroom training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
15-16 Jun 2022
Live online
08:30-17:00 UK (London) (UTC+01)
09:30-18:00 Paris (UTC+02)
03:30-12:00 New York (UTC-04)
Course code 11675
- GBP 1,299
- EUR 1,859
- USD 2,098
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,026 2,338
Until 16 Aug
- 2 days classroom-based training
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
7-8 Dec 2022
Live online
08:30-17:00 UK (London) (UTC+00)
09:30-18:00 Paris (UTC+01)
03:30-12:00 New York (UTC-05)
Course code 11952
- GBP 1,099 1,299
- EUR 1,579 1,859
- USD 1,786 2,098
Until 02 Nov
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Medical Device Regulations in the Middle East and North Africa training course
Very good course, covered just enough to have a good overview in amount time given.
Jun 19 2019
Agata Chmielewska 
RA/QA Specialist, CooperVision
Jun 19 2019
I was hoping to get clarification on regulations in the MENA market and find out about any updates and I believed I have accomplished that. A very good course – organised very well, great venue and good speakers.
Agata Chmielewska
RA/QA Specialist, CooperVision
Jun 19 2019
Very good course, covered just enough to have a good overview in the time given. The course was organised very well, a great venue, good speakers.
Agata Chmielewska
RA/QA Specialist, CooperVision
Jun 19 2019
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
Jun 19 2019
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
Jun 19 2019
Very good course, covered just enough to have a good overview in amount time given.
Agata Chmielewska
RA/QA Specialist, CooperVision
Jun 20 2018
It was good. The flow was very nice.
Stephanie de Souza 
Regulatory Officer, Vertex-Dental B.V.
Jun 20 2018
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
May 22 2017
Very good presentations and binder
Anette Hulstrøm 
Specialist Regulatory Affairs, William Cook Europe ApS
May 22 2017
Good structure
David Owolabi
Senior Regulatory Specialist, Steris Ltd
May 22 2017
All great
Simona Fiori 
Regulatory Market Specialist, Orthofix Srl
May 22 2017
Very good, covered many countries in a short time. Will recommend the course.
Manuela Müller-Maissen 
Senior Regulatory Affairs Specialist, Varian Medical Systems
United Kingdom
- Annette Callaghan Ltd
- ArjoHuntleigh AB
- Biomet UK Healthcare Ltd
- Britannia Pharmaceuticals Ltd
- BSN medical GmbH
- CooperVision
- CooperVision Manufacturing Ltd
- Hospira, a Pfizer company
- Molnlycke Healthcare
- Olympus Keymed
- Olympus KeyMed Ltd
- Research Instruments Limited
- Sinclair Pharma
- Sinclair Pharmaceuticals
- Steris
- Steris Ltd
- Stryker/HeartSine
- Sybermedica Ltd
- Thermo Fisher Scientific
Switzerland
- Beckman Coulter International SA
- Biotronik AG
- Ginsana SA
- Horus Pharma International
- Institut Straumann AG
- ISS AG, Integrated Scientific Services
- Nobel Biocare Holding AG
- Nobel Biocare Services AG
- Novartis Vaccines Diagnostics Services AG
- Varian Medical Systems
- Varian Medical Systems International AG
- Zimmer GmbH
United Arab Emirates
- Asahi Intecc Co., Ltd.
- Hospira (ME & NA)
- Johnson & Johnson
- MAQUET Middle East FZ-LLC
- Omron Healthcare Middle East
- Paul Hartman Middle East FZE
- Pfizer Gulf FZ LLC
- PHIBO Middle East
- Smith & Nephew US Limited
- Smiths Medical International Ltd
- Thermo Fisher Scientific Middle East
Netherlands
- Bayer Medical Care B.V.
- Bayer Medical Care BV
- Fresenius HemoCare Netherlands BV
- MEDRAD Europe BV
- Merit Medical EMEA
- Merit Medical Nederland BV
- Omron Healthcare Europe BV
- Vertex-Dental B.V
- Vertex-Dental B.V.
Denmark
- Coloplast A/S
- Cook Medical
- Radiometer Medical ApS
- William Cook Europe ApS
Saudi Arabia
- Novo Nordisk Gulf Health Care
- Saudi Food and Drug Authority
- TUV RheinlandInternational GmbH
- Varian Medical Systems Int AG
Australia
- CareDX Pty Ltd
- Cochlear Limited
- Ego Pharmaceuticals Pty Ltd
France
- DextReg
- Horus Pharma
- Septodont
Italy
- Orthofix
- Orthofix Srl
- Sorin Group Italia S.r.l.
Belgium
- Fujirebio-Europe NV
- IBA
Austria
- Croma-Pharma GmbH
Germany
- WEINMANN Emergency Medical Technology GmbH + Co. KG
Ireland
- Medtronic Ireland
Jordan
- Fakhoury Medical Supplies Est - F.M.S.
Poland
- LiNA Medical Polska Sp. z o.o.
United States of America
- Olympus Surgical Technologies America
Run Medical Device Regulations in the Middle East and North Africa Live online/Classroom for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
