ABSTRACT
Classification, requirements, and evaluation of medical devices in UAE are supported by the UAE Pharmacy Law No. 4 for 1983
System in UAEThe UAE regulatory system is mostly based on the recommenda-tions of the Global Harmonization Task Force (GHTF) for medical devices (for types of certification, approval, and clearance system according to product class and rules of classification of these systems considered and accepted), and adapting with (a) EU Medical Device Directives 93/42/EEC, EU in vitro Diagnostic Device Directive (IVDD) 98/79/EC and EU Active Implantable Medical Device Directive (AIMDD) 90/385/EEC. (b) United States Food and Drug Administration (US FDA) (c) Australia Therapeutic Goods Administration (TGA) (d) Singapore Health Sciences Authority (HSA)The regulatory body of medical devices/IVD is the RDCD — Medical Practice and License Sector.Contact Information:Key contact persons:Dr. Amin Al AmiriAssistant Undersecretary for Medical Practice and License,Ministry of Health, Abu Dhabi, P.O. Box 848, UAE Telephone: +971 26117434Fax: +971 2636742Dr. Fatima AlbraikiDirector of Registration and Drug control Department,Ministry of Health, Abu Dhabi, P.O. Box 848, UAETelephone: +971 26117421Fax: +971 2636742www.moh.gov.ae
Figure 38.2 Medical device marketing approval flow chart with pre-importation approval for each consignment. 38.4 Approval on Importation LevelMedical devices those are not subject for listing or registration (a) printing graphing papers (b) accessories for listed or registered medical devices (c) medical device instruments operating solvents or liquids that do not contact patients (d) woven and nonwoven clothing materials and their products (gowns, masks, support bandages, clothes, mattresses, etc.) (e) hospital and clinic furniture, wheelchairs, walking support devices (f) in vitro diagnostic reagents given that they are not self-testing or high-risk (A or B classes). (g) optical lenses, except contact lenses (h) external prosthesis (artificial extension that replaces a missing body part) not intended for implantation. (i) disposables and their equivalent: not intended for treating disease (tongue pressers, medical trash bins, gloves, diapers, disposable bedsheets, etc.) (j) casts, plastic casts, collars, or any external devices to support the movement or stabilizing of joints or the body parts (k) materials and accessories used in manufacturing dental parts, dentures, dental braces, given that they are not intended for implantation within oral cavity and jaws. (l) hearing aids (nonimplantable)
38.5 Definition of a Medical DeviceA medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: (a) intended by the company and its manufacturing site to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of • diagnosis, prevention, monitoring, treatment or alleviation of disease • diagnosis, monitoring, treatment, alleviation of or compensation for an injury • investigation, replacement, modification, or support of the anatomy or of a physiological process • supporting or sustaining life • control of conception • disinfection of medical devices • Indicate the sterilization process completion • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
