Regulatory requirements of Medical Devices in MENA ... - DGRA

1 I Regulatory requirements of Medical Devices in MENA countries Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms-Universit t Bonn Vorgelegt von Dr. Fatemeh Samadi aus dem Iran Bonn, Februar 2015 II Betreuer und 1. Referent: Dr. Ehrhard Anhalt 2. Referent: Dr. Birka Lehmann III Table of Contents LIST OF TABLES .. V LIST OF ANNEXES .. VI LIST OF ABBREVIATIONS .. VII EXECUTIVE SUMMARY .. 1 1. INTRODUCTION .. 2 DEFINITION OF MENA COUNTRIES .. 2 MENA HEALTHCARE MARKET .. 2 MENA Medical Devices MARKET .. 4 2 Medical Devices REGULATION .. 8 Medical Devices REGULATION HISTORY .. 8 INTERNATIONAL Medical Devices REGULATORS FORUM.

2 10 Goals of the IMDRF .. 10 Technical documents .. 10 Definition of Medical Devices and In Vitro Diagnostic (IVD) Medical Devices .. 11 Classification System for Medical Devices .. 12 Essential Principles applicable to all Medical Devices including IVD Medical Devices . 13 Conformity Assessment Procedure .. 14 Summary Technical Documentation (STED) .. 19 3. Medical DEVICE REGULATION IN MENA COUNTRIES .. 22 Medical Devices IN GCC COUNTRIES .. 23 Kingdom of Saudi Arabia (KSA) .. 23 United Arab Emirates (UAE) .. 26 Qatar .. 30 Oman .. 30 Kuwait .. 32 Bahrain .. 33 Yemen .. 35 Medical Devices IN WESTERN ASIA COUNTRIES .. 38 Israel .. 38 Iran .. 40 Iraq .. 42 Jordan .. 43 Lebanon .. 46 Syria .. 47 West Bank and Gaza (Palestine) .. 47 Medical Devices IN NORTH AFRICA AND THE MAGHREB COUNTRIES.

3 50 Egypt .. 50 Morocco .. 52 Algeria .. 53 Libya .. 54 Tunisia .. 55 4. SUMMARY INTEGRATION OF Medical Devices REGULATION IN MENA REGION .. 58 IV 5. DISCUSSION .. 60 6. CONCLUSION, OUTLOOK .. 61 REFERENCES: .. 62 ACKNOWLEDGEMENT - DANKSAGUNG .. 68 DECLARATION ERKL RUNG .. 69 V List of Tables Table 1: Medical Devices Market in GCC countries .. 6 Table 2: Medical Devices Market in Western Asia countries .. 7 Table 3: Medical Devices Market in Western Asia countries .. 7 Table 4: worldwide Medical Devices regulation 8 Table 5: Diagrammatic Representation of the Classification System .. 13 Table 6: conformity assessment elements and responsibility of manufacturer .. 18 Table 7: conformity assessment elements and responsibility of RA or CAB .. 18 Table 8: Enforcement date of Medical Devices Marketing Authorizations KSA.

4 25 Table 9: UAE Medical Devices regulation: the required attachments per Devices 27 Table 10: Country Fact Sheet KSA .. 36 Table 11: Country Fact Sheet UAE .. 36 Table 12: Country Fact Sheet Qatar .. 36 Table 13: Country Fact Sheet Oman .. 36 Table 14: Country Fact Sheet Kuwait .. 37 Table 15: Country Fact Sheet Bahrain .. 37 Table 16: Country Fact Sheet Yemen .. 37 Table 17: Country Fact Sheet Israel) .. 48 Table 18: Country Fact Sheet Iran .. 48 Table 19: Country Fact Sheet Iraq .. 48 Table 20: Country Fact Sheet Jordan) .. 49 Table 21: Country Fact Sheet Lebanon .. 49 Table 22: Country Fact Sheet Syria) .. 49 Table 23: Country Fact Sheet Palestine .. 49 Table 24: Country Fact Sheet Egyp .. 57 Table 25: Country Fact Sheet Morocco .. 57 Table 26: Country Fact Sheet Algeria .. 57 Table 27: Country Fact Sheet Libya.

5 57 Table 28: Country Fact Sheet Tunisia .. 57 VI List of Figures Figure 1: Healthcare expenditure as a percentage of GDP per country .. 3 Figure 2: Healthcare expenditure on a per capita basis in the MENA stands at USD315 .. 4 Figure 3: Medical Devices market, by region .. 5 Figure 4: European Medical technology market growth rates.. 5 Figure 5: Exports and imports of Medical technology by country .. 6 Figure 6: The flow of information from the technical documentation to the STED .. 21 List of Annexes Annex I Results from country Annex II Medical Devices registration requirements in Annex III Medical Devices registration requirements in West Annex IV Medical Devices registration requirements in North Annex V On-line MDMA Application form Annex VI Statement for KSA Environmental Annex VII Attestation accompanying Application for Marketing Authorization Annex IIX Company registration form UAE.

6 97 Annex IX Product registration application form UAE..102 Annex X Application Form for Pre-qualification of Manufacturers of Medical Supplies to Participate in Ministry of Health Tenders Annex XI Checklist for foreign manufacturers Annex XII Declaration of Conformity Annex XIII Application for a Medical Devices registration Annex XIV Registration form For Medical Appliances & Lab Diagnostic kits Annex XV Company Profile Annex XVI Annex No. (5) of Tender No. 17 2011 VII List of Abbreviations AHWP Asian Harmonization Working Party AMC Authorization for Market Commercialization APEC Asia Pacific Economic Cooporation AR Authorized representative ASEAN Association of east Asian Nations CAPA Central Administration Pharmaceutical Affairs CAB Conformity Assessment Body CE Conformit Europ enne (French).

7 English: European Conformity CoA Certificate of Analysis Country Of Origin COME Central Office for Medical Equipment DPPC Drug Policy and Planning Center EIU Economist Intelligence Unit EP checklist Essential Principles checklist EU European Union FDA Food and Drug Administration FSC Free Sales Certificates GCC Cooperation Council for the Arab States of the Gulf GDP Gross Domestic Product GHTF Global Harmonization Task Force on Medical Devices GMDN Global Medical Devices Nomenclature GPCHE General People's Committee for Health and Environment HIV Human Immunodeficiency Virus i. e. Id est (Latin); English: that means IEC International Electronical commission IFU Instruction for use IMDR Interim Medical Devices Regulations IMDRF International Medical Devices Regulators Forum IMOH Israel Ministry Of Health ISIRI Institute of Standards & Industrial Research of Iran ISO International Standardization Organization IVD In Vitro Diagnostic JFDA Jordan Food and Drug Administration KSA Kingdom of Saudi Arabia LOA Letter OF Authorization VIII Ltd.

8 Limited MEC Ministry of economy and Commerce MENA middle east and North Africa MD Medical Devices MDNR Medical Devices National Registry MDMA Medical Devices Marketing authorization MDSAP Medical Devices Single Audit Program MMAA Ministry of Municipal Affairs and Agriculture MOH Ministry Of Health MOPH Ministry of Public Health MPHP Ministry of Public Health and Population MS Member State NCDCR National Center for Drug Control and Research NCMDR National Center for Medical Devices Reporting NHRA National Health Regulatory Authority NODCAR National Organization for Drug Cotrol and Research PMA Premarket approval PPRO Pharmaceutical Product Regulatory Office QMS Quality Management System RA Regulatory Authority RPS Regulated Product Submission RMS Risk Management System SA Saudi Arabia SG Study Group SaMD Software as a Medical Devices SFDA Saudi Arabia Food and Drug Authority STED Summary of Technichal Documentation UAE United Arab Emirates UDI Unique Devices Identification US United States USD United States Dollar WHO World Health Organization 1 Executive summary The objective of this Master Thesis is to define the Regulatory environment for Medical Devices in the middle east and the North African countries (MENA), to show their limits and their prospects.

9 The Medical Devices market in this area presents unique challenges and opportunities to international manufacturers in the health care sector. Although the Medical Devices market in the MENA region is very diverse most of the individual economies have shown sustainable growth. This growth is driven by several factors including a growing population of 400 million people, the price of oil and energy, an increase of the Gross Domestic Product (GDP) and the income per capita, an improved literacy rate, a larger middle class and also a higher disease rate. In this market Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. The growth of demand for sophisticated pharmaceutical and Medical products in the MENA region seen in recent years is only likely to continue.

10 Despite of the overall positive economic development in most of the MENA countries the Regulatory environment can be challenging. Publicly accessible written legislations are limited in these countries, sometimes are only available in the local language (mostly Arabic) and leave room for interpretation. Also important to mention in this context are the barriers for the continuing evolution of the Regulatory environment in some of these emerging countries due to their political instability, non-transparency and corruption. Against this background the efforts of the Global Harmonization Task Force (GHTF) to harmonize the Medical Devices regulation, offer a valuable contribution to ease the Regulatory interconnection and intercommunication between the individual countries and the international economic operators of the Medical Devices industry.