Read AM 2-2011 text version

Medical Device Registration in the United Arab Emirates

1. Introduction

The demand for medical services in the United Arab Emirates (UAE) and the other GCC Countries (Bahrain, Kuwait, Oman, Saudi Arabia and Qatar) is - based on a study of McKinsey & Company - predicted to increase by 240 % in the next 20 years. In basic terms, there are three drivers for this optimistic outlook, i.e.: · Predicted yearly population growth of 3% till 2025. · An aging Population (for example, in Saudi Arabia the number of people over 65 will increase more than sevenfold during the next 25 years). · Health-risk factors, where the diseases with the highest growth are cardiovascular diseases, diabetes eye diseases, musculoskeletal diseases and cancer. Consequently, it is not surprising that healthcare is among the priority sectors identified by the UAE government and that the UAE healthcare industry has shown extraordinary growth and significant progress in the past few years. The government's focus on healthcare is aimed not only at diversifying the oilreliant economy but also at developing an unprecedented healthcare infrastructure to ensure that adequate services are provided in the Emirates. Moreover, the UAE is taking active steps in order to create a healthcare destination that attracts patients from other GCC countries and the sub-Indian continent. However, the UAE will not be able to achieve these ambitious aims without foreign technology and know-how. The UAE is thus an important market for manufacturers of medical devices. It is worth mentioning that the UAE ­ unlike other GCC states - is a zero-tax country, i.e. the UAE does not levy any corporate taxes or personal income taxes. This tax-free situation and the geographical vicinity to the other GCC states also make the UAE an attractive location for setting up a trading

ARAB MEDICO 2/2011

vehicle for medical devices. This article aims to give a brief overview of the regulations and requirements a (foreign) manufacturer will face and has to meet prior the sale of his medical products in the UAE.

2. Overview of the registration procedure

Healthcare in general is regulated at both the federal and Emirate level. However, the registration of Health Care Devices is regulated by the UAE Medical Devices Registration Guideline (hereinafter referred to as "the Registration Guideline") issued by the Ministry of Health. Setting out the requirements for an application for regulatory approval, the Registration Guideline is aimed at maintaining a balance between ensuring product safety, quality and effectiveness and providing the public with timely access to medical devices and preventing the entry of unsafe or ineffective devices into the UAE market. In this connection, it should be mentioned that the Registration Guideline largely simulates internationally recognized rules and regulations such as the EU Medical Device Directive (93/42/EEC), the United States Food and Drug Administration Guidelines and the Australian TGA (Therapeutic Goods Administration). Those familiar with the European framework will recognize significant similarities regarding the classification of medical devices, its registration procedure and related regulations. The similarity of the Registration Guideline of the Ministry of Health is ­ inter alia ­ shown by the fact that certain definitions are very close to those provided by the EU Medical Device Directive. In this context, under the existing Registration Guideline a producer and importer of medical devices

Dr. Ghassan Azhari is a German lawyer (Rechtsanwalt) and accredited tax lawyer (Fachanwalt für Steuerrecht). He moved to Dubai in 2004 and founded Azhari Legal Consultancy (www.azhari-law.com) in 2005. Azhari Legal Consultancy is a multi-national law firm with lawyers and consultants from Germany, Korea, the Middle East and China. One of Azhari Legal Consultancy's areas of expertise is the healthcare sector. Azhari Legal Consultancy also assists its clients in finding a tax-optimized structure for their businesses in the Gulf region.

2

+ + +

www.arab-medico.com

+ + +

may be granted a simplified registration procedure for medical devices in the event that they have already received approval from recognized regulatory agencies, such as those in Europe, the USA, Australia, Canada or Japan.

distributor in the UAE it is advisable for him to use them as his authorized representatives. 3.3. Supporting Documents As in other jurisdictions, the Registration Guideline requires the applicant to maintain objective evidence on the safety and effectiveness of the medical device. In this context, the applicant has to provide the committee inter alia with the following documents and information: · Copies of all certificates related to ISO certification of ISO 9001:2000 standards., · The ISO 13485:2003 standard attested and authenticated GMP (Good Manufacturing Practice) original certificate issued by the relevant health authorities at country of origin attested and authenticated, · Device description, intended use, indications, directions for use, contraindications, warnings, precautions, potentially adverse events, · Specifications of material used in device manufacturing and packing, · Copies of certification and documents certifying conformity to product standards, safety, and effectiveness requirements and quality systems in design and manufacturing, · Data of first introduction and use, list of countries where it is marketed and details of the regulatory status. A summary of "mandatory" reported problems with the device since its introduction in the market, · Risk assessment comprising risk analysis, evaluation and reduction measures, · Detailed information on safety and effectiveness studies, which includes pre-clinical and clinical studies, process validation studies, software studies, software validation studies where appropriate, as well as literature studies, with a summary of studies, conclusions drawn from those studies and a bibliography of published reports dealing with the device, · Objective evidence on the biological safety of the device, details as to whether it contains animal or human tissue or their derivatives, · Peer-reviewed scientific literature and written reports, · Results and conclusions of human clinical studies,

3. Application Procedure and Regulations

The manufacturer or its local authorized representative is required to apply to the Committee on Medical device registration at the Ministry of Health in order to register their medical devices prior to first placement on the local market. A committee (hereinafter referred to as "the Committee") is competent to decide on an application; this is in turn under the supervision of the Drug Control Department, which itself is a division of the Ministry of Health. 3.1. Definition of Medical Devices The UAE Medical Device Registration Guideline defines a medical device as all products including accessories used in healthcare for diagnosis, prevention, monitoring or treatment of illness or handicap, but excludes drugs, and as a rule does not achieve its principal intended action in or on the body by pharmacological, immunological or metabolic means. Generally speaking, the particular definitions of medical devices of the registration guideline are very close to the definitions given by the EU Medical Devices Directive 93/42/EEC of 14 June 1993. 3.2. Required qualifications of the applicant An application to register a medical device in the UAE has to be made by the device manufacturer or its local representative. The local representative must be formally authorized by the manufacturer to handle the application process and the manufacturer's legal obligations and responsibilities with regard to placing the medical device on the UAE market. In this context, the authorized representative must be available at all times to interact between the medical device manufacturer and the Ministry of Health. In this context, it should be mentioned that a distributor can also act as an authorized representative. Thus, if the manufacturer has an existing affiliate or a

· Stability studies, · Price information, such as ex-factory price, CIF price, wholesaler price in country of origin and retail price in country of origin, · Post market requirements, i.e.: providing evidence of established procedures and systems for distribution records, complaint handling, adverse incident reporting and recall. These documents need to be submitted in English or Arabic. The applicant has to declare that all submitted documents are true and that he will be fully responsible for the product and post market plan submitted for complaint handling and recall and, finally, that he will fully comply with the requirements of the Drug Control Department after the placing of the product on the market. 3.4. One stage versus two stage application procedure According to Article 4.2 of the Regulation Guideline, the Committee has to decide whether it approves the registration of a particular medical device through either a one stage or two-stage registration procedure. The decision to apply a one stage or a two-stage procedure depends ­ inter alia ­ on the risk qualification of the medical device and whether it has already been registered with internationally recognized regulatory bodies. Consequently, in the event of an application of a medical device that has already been licensed, for example, in Europe, it is of paramount importance to provide the Committee with the relevant supporting documents. At this point, it should be emphasized that Annex 3 of the Registration Guideline ("Classification of Medical Devices") details four risk classes of medical devices for the purpose of registration. Class I refers to medical devices with a low risk, Classes II A and B to medical devices with a medium risk and Class III to medical devices with a high risk. For risk classification purposes, Annex 3 refers to the European Union Classification rules.

+ + +

www.arab-medico.com

+ + +

ARAB MEDICO 2/2011

3

4. Registration Certificate

If the applicant proves the safety efficacy and compliance of the medical device with all of the essential requirements and gets the approval of the Committee, a Registration Certificate will be granted. Upon the receipt of the Registration Certificate, the applicant is entitled to import and freely sell the registered medical device. A registration certificate is valid for 5 years unless significant changes are made to the approved application data. However, the Drug Control Department may cancel the registration certificate ­ inter alia ­ in the following events: · The non-compliance of the manufacturer with his post-market obligations, · The product proves to be unsafe or harmful to health, · The quality became substandard compared to its state at the time of the application, · The products differs from the approved label,

· Intellectual property rights of other similar products have been violated.

6. Conclusion

Foreign manufacturers of Medical devices will come across regulations they might be familiar with from their home jurisdiction as the UAE Registration Guideline is mainly a simulation of rules and regulations recognized by international regulatory benchmarks. Moreover, in the event that the particular product has already been registered in other jurisdictions with internationally recognized registration standards, they might enjoy certain easements during the registration procedure. If, however, the medical device in question has not been registered within a jurisdiction that has been judged to comply with international standards or does not need a registration in its home jurisdiction, the application procedure may demand time and resources. Despite this, due to the optimistic outlook in the health care sector the United Arab Emirates are a promising market for medical devices.

5. Post-Market Obligations

As mentioned above, in order to obtain a Registration Certificate the applicant has to provide evidence as to the manner in which he will fulfill certain post-market obligations. Consequently, after the registration of a medical device, the applicant has to implement a so-called Medical Device Vigilance System in order to minimize any risks of the health and safety of patients, users and others. In this regard, the manufacturers are obliged to maintain distribution records, to maintain complaint-handling procedures and records and to maintain adverse incident reporting procedures and records and to have a recall system in place. In the event that the manufacturer violates his post-market obligations, the Drug Control Department may cancel the registration certificate.

ANZEIGE

4

ARAB MEDICO 2/2011

+ + +

www.arab-medico.com

+ + +

IóëàYG á«Hô©dG äGQÉeE'G ` á«Ñ£dG äGó©YG «é°ùJ

ióe áÉ°U « é °ùàdG äGOÉ¡ °T ¶ Jh Gòg ájQòL äGÒ¨J ÉNOEG ºàj / Ée äGæ°S á°ùªN AɨdEÉH AGhódG áÑbGôe º°ùb j hCG ,RÉ¡÷G Y á«ÑJ óY É¡æe á°UÉN ä'ÉM ` «é°ùàdG Öéj «é°ùàdG ó©H .j°ùàdG ó©H Ée äÉeGõàdG á°UÉÿG ᶫdG ÒjÉ©e «Ñ£J Ö£dG óe Y ¢ØN ` áªgÉ°ùYG ±ó¡H á«Ñ£dG äGó©YÉH óîà°ùYG É¡d ¢Vô©àj ób »àdG á«ë°üdG ôWÉiG .ºgÒZh ¢jôYGh áHÉ£e âÑãJ »àdG äGOÉ¡°ûdG TM«ªL øe ï°ùf - äÉ eóÿG ¤EG á LÉG OGOõ J ¿CG TM b àYG ø e øeh »é«ÿG ¿hÉ©àdG ¢ù> hO ` á«Ñ£dG 2000 :9001 hõjE'G ÒjÉ©e OÉ©j Éà IóëàYG á«Hô©dG äGQÉeE'G ádhO É¡æ«H 200313485 hõ jE'G á HÉ £ e IOÉ ¡ °T - ©éj É ,áÑYG áæ°S øjô°û©dG ÓN %240 GMP «KJ øe É¡«Y ¥ó°üe á«°UCG áî°ùfh »àdG äÉYÉ£dG ÌcCG øe á«ë°üdG ájÉYôdG ´É£b .CÉ°ûæYG óH ` á°üàiG á¡÷G øe QOÉ°üdG dPh ,kÉ°UÉN kÉeɪàgG äGQÉeE'G áeM É¡«dJ ¢VGôZCG º°J ᪠FÉbh RÉ¡÷G äÉØ °UGe - á«àëàdG á«æÑ dG ôj£ J á °UGe ÓN øe ¥G°SC'G óMCG äGQÉeE'G ádhO ã"h Gòg .Iõ«ªàYG Góîà °S'G á« Ø « ch ɪ © à °S'G »YGhOh ¢üNC'G Yh á«Ñ£dG äGó©YG »©æ°üY áHGò÷G äGÒKCÉàdGh äGôjòëàdGh Góîà°S'G TMfGeh ñÉ æYGh `Gô ¨÷G É ¡ © b e ¤EG ô ¶ æ dÉ H .áªàÙG á«ÑfÉ÷G .ºFÓYG ...OÉ°üàb'G .«¨àdG OGeh TMæ°üdG OGe äÉØ°UGe IóY ¤EG á«Ñ£dG äGó©YG «é°ùJ ᫪Y TM°îJ èàæYG ÒjÉ©e áHÉ£e äGOÉ¡°T øe ï°ùf - »àdGh ,äGQÉeE'ÉH áë°üdG IQGRh É¡à©°Vh óYGb ¿Éª°V ÚH í«ë°üdG ¿RGàdG OÉéjEG ¤EG ±ó¡J IO÷Gh IAÉØdGh ¿ÉeC'G ÒjÉ©e áHÉ£eh äGó©YG ÒaJ ÚHh èàæYG IOLh IAÉØch ¿ÉeCG .TM«æ°üàdGh º«ª°üàdG ` øe ¥G°SC'G ájɪMh ÚæWGYG ájÉYôd áãjóG áªFÉbh ,ɪ©à°SGh j°ùJ hCG øY äÉfÉ«H - Ñ£J .ɪ©à°SÓd áÉ°U Ò¨dG á«Ñ£dG äGó©YG äÉe©eh RÉ¡÷G É¡H ¥°ùj »àdG hódÉH ` áeóîà°ùYG äGó©YG TM«ªL Y óYGdG J .ÊfÉdG TM°VdG øY á««°üØJ ,äÉ«dɪdG dòch êÓ©dGh ájÉbdGh ¢ü«î°ûàdG º««Jh «­ dP ` Éà ôWÉiG º«« J - »àdG á«f'ó«°üdG äGô°ëà°ùYG AÉæãà °SG TMe J KÉ" .»FGhódG êÓ©dGh ájÉbdG ` óîà°ùJ .ô£ÿG ä'ɪàMG ¢ØN äGAGôLEGh ô£ÿG á«dhódG ÚfGdGh óYGdG ó«©H óM ¤EG óYGdG áØàiG äÉ°SGQódG øY á««°üØJ äÉe©e - É jôeCGh á« HhQhC'G hódG É¡ à © °Vh » à dG §«°ùÑJ ` ºgÉ°ùj É ,¿ÉHÉ«dGh Góæch É«dGΰSGh ¿ÉeC'G Y IOó©àe MGôe ` âjôLCG »àdG á«Ñ£dG äÉéàæYG øe ÒãdG «é°ùJ äGAGôLEG .IAÉØdGh äÉ¡÷G øe kÉÑ°ùe kÉ«KJ Y â°üM »àdG »Ld«ÑdG ¿ÉeC'G âÑãJ á«Y°Ve F'O .kÉ«dhO É¡H ±Î©YG ᫪°SôdG hCG á«fG«M äÉf e ájCG øY äÉe © eh «cdG hCG TMæ°üYG ËóàH «é°ùàdG äGAGôLEG GC óÑJ .É¡JÉà°ûe hCG ájô°ûH áé°ùfCG äGó©YG «é°ùJ áæ÷ ¤EG kÉÑW »ÙG ´RYG / áHàe ôjQÉJh á©LGôe ᫪Y äGQ°ûæe - AGhódG áÑbGôe º°ùb ±Gô°TEG â­ TMJ »àdG á«Ñ£dG á«« æ « cE'G ájô°ûÑdG äÉ°SGQódG èFÉà f - ·ô°T dPh ,äGQÉeE'ÉH áë°üdG IQGRd TMHÉà dG àH É«dG ¬dîj kÉ«ª°SQ oÓ«cJ Y ¬d°üM QGôà°S'G äÉ°SGQOh á«ffÉdG äÉ«dÄ°ùYG TM«ªL ª­h äGAGôLE'G .èàæYG j°ùàH á°UÉÿG äÉeGõàd'Gh áØàiG QÉ©°SC'G øY á««°üØJ äÉfÉ«H âÑãj Ée ËóJ ãe j°ùàdG ó©H Ée äÉÑ£àe - äGóæà°ùYG ËóJ Öéj ,«é°ùàdG óYGd kÉÑWh á«Hô©dG hCG ájõ«,E'G á¨dÉH á«dÉàdG äÉe©YGh áà HÉK TMjRJh j°ùJ äGAGôLEG « Ñ £ J IAÉØch ¿ÉeCG âÑãJ »àdGh á°üàiG áæédG ¤EG ¡à °ùYG i °T TMe eÉ© à dG Ö«dÉ°SCGh :á«Ñ£dG äGó©YG OGOΰSGh á« Ñ fÉL QÉ KBG á jCG ø Y ÆÓ HE'Gh .èàæYG

+ + +

www.arab-medico.com

+ + +

ARAB MEDICO 2/2011

5

Information

AM 2-2011

4 pages

Find more like this

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

553507