塑造海湾合作委员会的五大健康和生命科学趋势

Version Number:3.0Version Date: ../../2024 Table of Contents Purpose....................................................................................................................3Scope.....................................................................................................................................3Background..............................................................................................................3 Pre-MDMA Application Assessment...........................................................................4Priority MDMA Application review............................................................................4 Innovative Medical Device Designation Criteria...................................................................4 SFDA Facilitation for Innovative Medical Devices...............................................................5 Facilitations for Pre-Submission Assessment Pathway...................................................5Facilitations for Priority Assessment for MarketingAuthorization Pathway.....................5 Annexes......................................................................................................................................8 Annex (A): Application Form for Innovative Medical Device.........................................9Annex (B): Innovative Medical Devices Requirements and Procedures Inquiries Form....11Annex (C):Innovative Medical Device Roadmap........................................................12Annex (D): Definitions and Abbreviations.................................................................14Annex (E): List of Changes on the Previous Version...................................................15 Introduction Innovative Medical Devices have an important role in improving and facilitating both patients’andhealthcare practitioners’ quality of life. The delays in access to Innovative Medical Devicescould limituseofsuchtechnologies that provide superior effectivenessin diagnosis, treatmentor monitor. The SFDA has introduced adedicatedpathway for Innovative Medical Devices to acceleratethe regulatoryprocedures and facilitate patients’ and healthcare practitioners’access to noveltechnologies with significant benefits over available products while ensuring safety andeffectiveness. Purpose The purpose of this guidance is to specify the designation criteria for Innovative MedicalDevices,associated review processes, and the features of the pathway to outline therequirements for applying through the Innovative Medical Devices Pathway, and to explain thesubmission process. Scope This guidance applies to innovators, developers, manufacturers, and authorized representativeswishing to obtain Medical Devices Marketing Authorization for Innovative Medical Deviceswhich is defined inAnnex (D): Definitions and Abbreviations. Background SFDA has issued this guidance document in reference to Article9of the“Low ofMedicalDevices”issued by the Royal Decree No. (M/54) dated 6/7/1442 Hindicating that“the SFDAmayexcludeaninnovative medical device from some of theconditionsand procedures to obtaina marketing authorization in awaythat does not affect its safety andperformancewhen usedas intended,as determined by the Regulation. Innovative Medical Devices Pathways The innovative medical device journey begins with establishing an innovative concept that goesthrough multiple iterations and developments (seeannex C,Part A) that shall account for pre-clinical considerationsand may include the request of product classification by SFDA(seeannex C,part B) to ensure that the innovative product is safe and effective.This pathwaywillcontinue to require providing evidence that the medical device meets the Essential Principlesfor Safety and Performance (EPSP). The pathway is comprised of two stages: Pre-SubmissionAssessment and Priority Assessment for Marketing Authorization.The process of InnovativeMedical Devices Pathways is outlined in aflowchart. Pre-MDMA ApplicationAssessment The first stage is intended to providefree of charge,continuousfeedbackand guidancebasedonSFDAexpectationsandregulatory requirements during medicaldevice’stechnical filepreparation andpriorto applying for marketing authorization. PriorityMDMA Application review The second stage is intendedto provide a priority for the innovative medical deviceMDMAapplicationto be reviewed infront ofMDMA applications queue.Such priority does not meanthatMDMA technical file assessmentwill be shortened or reduced in any way,itjustmeansthat theassessment,that would be comprhensivedue tothe novelty of the technology, willcommence sooner after receipt ofthe technical file. Innovative Medical Device Designation Criteria This section outlines the criteria for eligibility for a medical device to be considered innovative.A medical device may be designated as an Innovative Medical Device if it meets the followingconditions: −The medical device is designed with innovative