> Ya nhr BAHRAL ef nf Aaland oe gil ung Ayal eShtayuaso Chief Executive office ircular No. (8) 2018 Date: 16 October 2018 To all Combined Medical Device Importers Sub: Classification of criteria of Medical Combined Device The National Health Regulatory Authority would like to draw the attention of Medical devices Importers, that a new producer to classify Combined Medical Device will be implemented based on the following new criter ‘The product must be classified as a Medical Device in one of the following regulatory authorities: Saudi Arabia, America, Australia, Canada, Japan, New Zealand, Switzerland, United Kingdom, France, Ireland, Netherlands, Denmark, Belgium. If the product was not classified as a medical device in these regulatory authorities, the following criteria must be full filled: = Should be classified in the country of origin as a medical device. - Holds CE or ISO 13485 certification. - Its Medical claim, comply with medical device definition. - It’s Mode of Action, comply with Medical Device definition. ~ Active ingredients percentage does not contradict with percentage for drug classification, Your cooperation is highly appre health services in the Kingdom. Son y oyaulldstoo Kingdom of Bahrain 2018 Aiad (8) 8) apert 2018 »sisl 16 0) Aaatall Asuall 3 3g) gs ginwe Gan co!) Peatall coal Sigal pulee ciiaat 26 ye gall Axa Zope 55490 cus yghall LS! Cali of Magda nail ail ya AN AY) aie ag he ‘eg lHDS dena Sb 5 jg) Steal o« 9 Ayo gh pss FhgaS inns iil OSs Gf AN 48 cOMLM aS Ul ial Sy yal yrgeall del) ALudt Naya al yh Lib canal Mela lj go ale MSsaly ol call AyD Cigall gi gol jyaS Gaal! ye gill oh Lele AM AY! le eis Aisin sins code! 5 y Shall apt Seas Lidl ob Gi ee a6 al - J CE gid tye Gus tet Gk dal. 18013485 pill ga Gael jae ll cleat « spt gal) Gig il title gill Jaw Mis a algal oye ge Ga gkii Y 4d Mail! Sali as - ol gall Cajiaal oaainall 4) gall eB YI A Slall 653 fs gle (SSS dann gi a Le bbe ASL Apaecall Clea Jandel) gle By giSal eit) Ga tel Fax 0, Box: 11464, Manama 197317113338 Kingdom of Bahrain 2973.17 113359 ail Website infosnba.bh vwwenbvabh