<p>The healthcare industry in the UAE is set to boom. Dubai is in the process of  setting itself up as a regional hub for medical tourism, and there is a drive  towards improving the standard of healthcare throughout the country. This  article briefly outlines the regulatory approval process for medical devices in  the UAE. <br /><br /><strong>General Background</strong><br />The Ministry of Health  has issued registration guidelines for medical devices. The Registration  Guidelines set out the requirements for an application for regulatory approval.  The registration system is intended to prevent unsafe or ineffective medical  devices from entering the local market, while allowing patients access to  medical devices that may help them.<br /><br />The Ministry has aimed for  international standards in developing the criteria for medical device  registration. The Registration Guidelines themselves acknowledge that the  various requirements for registration largely simulate internationally  recognized rules and regulations such as the EU Medical Device Directive  (93/42/EEC) and US Food and Drug Administration Guidelines. By way of example,  the Registration Guidelines define various terms using the definitions that  closely resemble those provided in the EU Medical Device Directive.  <br /><br /><strong>Application requirements</strong><br />An application to register  a medical device in the UAE must 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&rsquo;s legal  obligations and responsibilities with regard to putting the medical device on  the market in the UAE. <br /><br />The Registration Guidelines provide four classes  of medical device for the purposes of registration. The classification system  takes into account aspects such as the period of time for which the medical  device is intended for use, and the degree of invasiveness on the body.  <br /><br />Depending on the classification of the medical device in question, and  the information available with regard to approvals by regulatory bodies  elsewhere, the Ministry&rsquo;s Committee on Medical Device Registration will consider  an application for registration through either a one stage or a two stage  process. Upon application, the Committee will review the medical device and  decide whether or not it is able to issue a certificate of registration on the  basis of the material submitted with the application, or whether further  evidence relating to safety and effectiveness needs to be considered before a  formal determination can be made. <br /><br />The application must be supported by  the submission of objective evidence relating to the safety and effectiveness of  the medical device. As in other jurisdictions, the preparation and submission of  such advice is a significant undertaking. The Registration Guidelines list the  information that it is necessary to file in order to be considered for  registration. As well as the formally executed official application form, and  depending on the classification of the device, the necessary documents can  include:</p>
<ul>
<li>Authenticated copies of certificates relating to governmental approval of  the device&rsquo;s manufacturing facility in the country of origin.</li>
<li>Copies of all certificates, documentation and letters of regulatory  approval/clearance to manufacture, sell, import and export the medical  device.</li>
<li>Evidence of established procedures and systems for distribution records,  complaint handling, adverse incident reporting and recall.</li>
<li>Product and production information, such as manufacturing process and  facilities information, device description, specifications of materials used in  manufacturing and packaging, intended use and instructions for use,&nbsp; indications  and contraindications, warnings and precautions, potential adverse events,  alternative therapy, device labeling, shelf-life stability, animal/human tissue  content.</li>
<li>Copies of certification and documentation certifying conformity to product  standards, safety and effectiveness requirements, and quality systems in design  and manufacturing.</li>
<li>Date of first introduction and use, list of countries where device is  marketed and details of corresponding regulatory status, and a summary of  reported problems with the device since introduction.</li>
<li>Risk assessment comprising of risk analysis, evaluation and reduction  measures, and detailed information on safety and effectiveness studies,  including pre-clinical and clinical studies, process validation studies,  software validation studies where appropriate, and literature studies, with  summary of studies, conclusions drawn from those studies and bibliography of  published reports dealing with the device.</li>
<li>Objective evidence on the biological safety of the device.</li>
<li>Peer-reviewed scientific literature dealing with the device.</li>
<li>Price information, including ex-factory price, wholesale price in the  country of origin, and retail price in the country of origin.</li>
</ul>
<p>As well as the documents and information listed above, it is also necessary  for the applicant to submit a declaration confirming that the submitted material  is true and that the applicant will be fully responsible for the medical device  and its post market plan, and that the applicant will comply with the  requirements of the Ministry&rsquo;s Drug Control Department (the &ldquo;DCD&rdquo;) after the  medical device has been placed on the market. <br /><br />As far as formalities are  concerned, it should be noted that the Registration Guidelines are somewhat  prescriptive when it comes to the way in which the materials are prepared and  submitted, and all documents, including certificates should be in English or  Arabic. <br /><br /><strong>Registration</strong><br />If the safety and effectiveness  of the medical device is established and the Committee approves the  registration, a certificate of registration is granted, and the importation and  sale of the registered medical device is permitted. The registration is valid  for 5 years, although if there are material changes to the product data  submitted in support of the application, then the certification may become  invalid. The DCD is also entitled to cancel the registration of a medical device  if the registrant so requests, or if circumstances warrant cancelling the  registration. We anticipate circumstances warranting cancellation to include,  for example, where post-market obligations have not been met, where the product  proves to be unsafe or the quality of the product becomes lower than at the time  of the application for regulatory approval, where unapproved labeling is  adopted, and where the medical device infringes a third party&rsquo;s intellectual  property rights. <br /><br /><strong>Post-market obligations</strong><br />As the key  purpose of registering medical devices is to ensure safety, the Registration  Guidelines provide for post-market obligations with regard to monitoring, and  preparing for, safety issues that may arise in the market place. As noted above,  failure to comply with these obligations is a basis upon which the DCD can  cancel the registration of a medical device. <br /><br />The post-market obligations  include the obligation to maintain distribution records (to facilitate  traceability), to maintain complaint handling procedures and records, to  maintain adverse incident reporting procedures and records, and to have  procedures in place that will allow the registrant to promptly and effective  execute investigations and recalls in respect of defective or potentially  defective medical devices. <br /><br />If post market procedures have already been  established by a registrant for one type of registered medical device, it is not  necessary to resubmit the post-market procedures for other medical device  registration applications, unless the procedures previously outlined have  changed or need to be varied due to the nature of the subsequent medical device.  If procedures have been submitted in respect of a previous application, it will  be sufficient to refer the authorities to that material.  <br /><br /><strong>General</strong><br />It can sometimes be difficult for foreign  applicants to meet regulatory requirements for medical devices. One example of  the type of problem that might be encountered is where the subject medical  device is not something that would require regulatory approval in the country of  origin, and thus not something for which country of origin approval  documentation can be provided. <br /><br />Al Tamimi &amp; Company is able to assist  with all aspects of medical device regulatory approval, particularly in respect  of advocacy relating to the acceptance of supporting documentation. Although we  hope it will not be required, we are also able to assist with recalls and  product liability issues.</p>