MDS G20 Guidance On Requirements For Clinical Investigations Of Medical .
MDS – G20Guidance on Requirements forClinical Investigations of Medical DevicesVersion Number: 3.0Version Date: 26/12/2018This guidance document has been published after being distributed for public comments dated on6/10/2016 for 30 days.Page 1 of 23
Table of ContentIntroduction . 3Purpose . 3Scope . 3Background . 3Requirements . 4Required Documents . 5Flowchart . 8Annexes . 9Annex (1): Definitions and Abbreviations . 10Annex (2): Application Form for CIMD . 15Annex (3): Disclosure of Principal Investigator Conflict of Interests . 22Annex (4): Change Form for CIMD . 23Page 2 of 23
IntroductionPurposeThe purpose of this document is to clarify the requirements of conducting CIMD within the KSA.Scope This document is applicable to any party wishes to conduct CIMD within the KSA.BackgroundSFDA/MDS has issued this guidance document in reference to Article Four of the "MedicalDevices Interim Regulation" issued by Saudi Food and Drug Authority Board of Directors decreeNo. (1-8-1429) dated 29/12/1429 H and amended by Saudi Food and Drug Authority Board ofDirectors decree No. (4-16-1439) dated 27/12/2017 stipulating that the SFDA undertakes issuingthe approval for conducting clinical investigations and clinical evaluation.Page 3 of 23
RequirementsGeneral1Any CIMD within KSA shall be approved by SFDA beforecommencement.2Investigational medical devices imported for clinical investigationmay access KSA only if SFDA’s importation approval is obtained.3CIMD shall be approved by the EC that is registered at NationalCommittee of Bio Ethics (NCBE).4CIMD shall comply with the Law of Ethics of Research on LivingCreatures.5CIMD should be in accordance with: Declaration of Helsinki ISO 14155 (or any equivalent standard GCP)LabelingRequirements6The labeling of the device shall comply with the requirementsdescribed in SFDA’s guidance document entitled MDS – G10Guidance on Labeling Requirements for Medical DevicesReporting ofSerious AdverseEvent andDeviceDeficiency7The Sponsor shall report to the SFDA’s NCMDR about any seriousadverse events or device deficiencies that could have led to a seriousadverse device effect, including serious health threat. This shall bereported without delay but not later than 15working days after thesponsor first knowing of the events.SubmittingDocuments toSFDA8Sponsor (either located within the KSA, or outside the KSA throughhis AR) shall submit the required documents by email toMDCI@sfda.gov.sa as follows:1. prior to CIMD, the required documents are specified in section(A) of “Required Documents”. Once satisfied, SFDA will senda “No Objection Letter” to the applicant’s emailRegulations andStandards2. during the CIMD, the required documents are specified insection (B) of “Required Documents”.3. at the end of the CIMD, the required documents are specifiedin section (C) of “Required Documents”.Inspection of theCIMD9SFDA has the right to inspect the CIMD without previous notification.Reviewing Fees10 No fees are required.Page 4 of 23
Required DocumentsRequired DocumentsNote(A) Required documents prior to CIMD1Application Form. See Annex (2) See point (8) of “Requirements” SFDA responds within a week in case ofmissing documents. Application reviewing time is 60 working days.2Labelling of device. 3Clinical investigation agreementbetween sponsor and clinicalinvestigation site(s)/principalinvestigator(s) 4Clinical investigation agreementbetween sponsor and CRO 5EC approval letter It is required for each site The EC shall be registered at NationalCommittee of Bio Ethics (NCBE)6Clinical Investigation Plan (CIP) 7Investigator's Brochure (IB) It is required only for premarket studies. For post market studies, instructions for deviceuse is required.8Informed consent It shall be in Arabic and English9Clinical investigation insurance forsubjects It shall cover the cost of treatment of subjects inthe event of injuries related to clinicalinvestigation for interventional studies10Curriculum Vitae of principalinvestigator(s) and investigator(s) 11Disclosure of Principal InvestigatorConflict of Interests See point (6) of “Requirements”If applicableSee Annex (3)It should be signed by PINote: Incomplete application will be deleted after 60 days.Page 5 of 23
(B) Required documents during CIMD It shall be submitted in yearly intervals, at least.12Progress Report13Change Form for amendments to any See Annex (4)documents already approved by For non-substantial changes [e.g. minorSFDAlogistical or administrative changes, change ofmonitor(s), telephone numbers, renewal ofinsurance] not affecting the rights, safety andwell-being of human subjects or not related tothe clinical investigation objectives orendpoints, a simple notification to SFDA can besufficient*.14Change principal investigator The sponsor shall provide:1. New PI CV2. IRB approval of PI change3. Any document and agreements signed bythe previous PI need to be updated andsubmitted .15Withdrawal of EC approval Sponsor shall notify SFDA in case of withdrawalof EC approval or part of it, within five workingdays of receiving the withdrawal notice16Notification of suspension orpremature termination of the clinicalinvestigation. It shall be submitted to SFDA without delay butnot later than:o five working days in case of suspension orpremature termination because of safetygroundso 15 working days in case of reasons otherthan safety grounds .o Justification is requested in the case ofpremature termination, suspension andresuming after suspension.17Major deviations from theinvestigational plan that have asubstantial impact on the safety orrights of subjects or on therobustness or reliability of theclinical data generated by theinvestigation It shall be submitted without delay but not laterthan five working days18Evaluation report of the seriousadverse device events or devicedeficiencies that lead to seriousadverse device effect. It shall be provided to the SFDA without delaybut not later than 15 working days from thesponsor first knowing about the serious adverseevent.Page 6 of 23
(C) Required documents at the end of the CIMDclinical It shall be provided to the SFDA from the lastpatient follow up completed but not later than10 working days.19Notificationofainvestigation completion.20Clinical investigation final report It shall be submitted to the SFDA without delaybut not later than 12 months after the clinicalinvestigation completion.Page 7 of 23
FlowchartPage 8 of 23
AnnexesPage 9 of 23
Annex (1): Definitions and AbbreviationsKSAKingdom of Saudi ArabiaSFDASaudi Food and Drug AuthorityMDSMedical Devices SectorGHTFGlobal Harmonization Task ForceMDMAMedical Devices Marketing AuthorizationNCMDRNational Center for Medical Devices ReportingARAuthorized RepresentativeCIMDClinical Investigations of Medical DevicesCROContract Research OrganizationCIPClinical Investigation PlanECEthics Committee/Institutional Review BoardIBInvestigator's BrochureNCBENational Committee of Bio EthicsGCPGood Clinical PracticeAdverse Events (AE)*any untoward medical occurrence, unintended disease or injury, oruntoward clinical signs (including abnormal laboratory findings) insubjects, users or other persons, whether or not related to theinvestigational medical device.Note 1: This definition includes events related to the investigationalmedical device or the comparator.Note 2: This definition includes events related to the proceduresinvolved.Note 3: For users or other persons, this definition is restricted toevents related to investigational medical devices.AuthorizedRepresentative (AR)means any natural or legal person established within the KSA whohas received a written mandate from the manufacturer to act on hisbehalf for specified tasks, including the obligation to represent themanufacturer in its dealings with the SFDA.Clinical Investigations* systematic investigation in one or more human subjects, undertaken(of Medical Devices)to assess the safety or performance of a medical device.(CIMD)Note: “Clinical trial” and “clinical study” are synonyms for“clinical investigation”.Clinical InvestigationPlan (CIP)*document that state(s) the rationale, objectives, design andproposed analysis, methodology, monitoring, conduct and recordkeeping of the clinical investigation.Note: The term “protocol” is synonym for “CIP”. However,protocol has many different meanings, some not related to clinicalPage 10 of 23
investigation, and these can differ from country to country.Therefore, the term CIP is used in this International Standard.Clinical InvestigationReport*document describing the design, execution, statistical analysis andresults of a clinical investigation.Contract ResearchOrganization (CRO)*person or organization contracted by the sponsor to perform one ormore of the sponsor's clinical investigation-related duties andfunctions.Deviation*instance(s) of failure to follow, intentionally or unintentionally, therequirements of the CIP.Device Deficiency*inadequacy of a medical device with respect to its identity, quality,durability, reliability, safety or performance.NOTE: Device deficiencies include malfunctions, use errors, andinadequate labeling.Endpoint(s)*〈primary〉 principal indicator(s) used for assessing the primaryhypothesis of a clinical investigation.establishmentNational RegistryNumbermeans the number issued to a person by the SFDA under theestablishment registration provisions of the Medical DevicesInterim Regulation.Ethics Committee(EC)*independent body whose responsibility it is to review clinicalinvestigations in order to protect the rights, safety and well-being ofhuman subjects participating in a clinical investigation.Note 1: For the purposes of this International Standard, “ethicscommittee” is synonymous with “research ethics committee”,“independent ethics committee” or “institutional review board”.The regulatory requirements pertaining to ethics committees orsimilar institutions vary by country or region.Note 2: In the KSA, all local ECs supervising a clinical study haveto be listed in The List of Registered Local Committees at theNational Committee of Bioethics (NCBE) in King Abdulaziz Cityfor Science & Technology ees/What are-the-localcommittees.aspxInformed ConsentProcess*process by which an individual is provided information and isasked to voluntarily participate in a clinical investigation.Note: Informed consent is documented by means of a written,signed and dated informed consent form.Investigation Site*institution or site where the clinical investigation is carried out.Note: For the purpose of this International Standard, “investigationsite” is synonymous with “investigation centre”.Investigational MedicalDevice*medical device being assessed for safety or performance in aclinical investigation.Page 11 of 23
Note 1: This includes medical devices already on the market, thatare being evaluated for new intended uses, new populations, newmaterials or design changes.Note 2: In this International Standard, the terms “investigationalmedical device” and “investigational device” are usedinterchangeably.Investigator*individual member of the investigation site team designated andsupervised by the principal investigator at an investigation site toperform critical clinical-investigation-related procedures or to makeimportant clinical-investigation-related decisions.Note: An individual member of the investigation site team can alsobe called “sub-investigator” or “co-investigator”.Investigator's Brochure(IB)*compilation of the current clinical and non-clinical information onthe investigational medical device(s), relevant to the clinicalinvestigationLabellingmeans written, printed or graphic matterAffixed to a medical device or any of its containers or wrappers.Information accompanying a medical device, related toidentification, technical description.Information accompanying a medical device, related to its use, butexcluding shipping documents.Legally AuthorizedRepresentative*individual or judicial or other body authorized under applicable lawto consent, on behalf of a prospective subject, to the subject'sparticipation in the clinical investigation.Medical Devicemeans any instrument, apparatus, implement, machine, appliance,implant, in vitro reagent or calibrator, software, material or othersimilar or related article:Intended by the manufacturer 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 ofdisease,Diagnosis, monitoring, treatment, alleviation of or compensationfor an injury or handicap,Investigation, replacement, modification, or support of the anatomyor of a physiological process,Supporting or sustaining life,Control of conception,Disinfection of medical devices,Providing information for medical or diagnostic purposes by meansof in vitro examination of specimens derived from the human body;AndPage 12 of 23
Which does not achieve its primary intended action in or on thehuman body by pharmacological, immunological or metabolicmeans, but which may be assisted in its intended function by suchmeans.National Centre forMedical DeviceReporting (NCMDR)means an organization managing a database of information onsafety and/or performance related aspects of medical devices andemploying staff capable of taking appropriate action on anyconfirmed problems.Objective*main purpose for conducting the clinical investigationPrincipal Investigator(PI)*qualified person responsible for conducting the clinicalinvestigation at an investigation siteNote 1 If a clinical investigation is conducted by a team ofindividuals at an investigation site, the principal investigator isresponsible for leading the team.Note 2 Whether this is the responsibility of an individual or aninstitution can depend on national regulationsSerious Adverse Event(SAE)*adverse event thata) led to death,b) led to serious deterioration in the health of the subject, that eitherresulted ina life-threatening illness or injury, ora permanent impairment of a body structure or a body function, orin-patient or prolonged hospitalization, ormedical or surgical intervention to prevent life-threatening illnessor injury or permanent impairment to a body structure or a bodyfunction,c) led to foetal distress, foetal death or a congenital abnormality orbirth defectNote: Planned hospitalization for a pre-existing condition, or aprocedure required by the CIP, without serious deterioration inhealth, is not considered a serious adverse event.Adverse device effect(ADE)*Adverse event related to the use of an investigational medicaldeviceNote 1: This definition includes adverse events resulting frominsufficient or inadequate instructions for use, deployment,implantation, installation, or operation, or any malfunction of theinvestigational medical device.Note 2: This definition includes any event resulting from use erroror from intentional misuse of the investigational medical devicePage 13 of 23
Sponsor*individual or organization taking responsibility and liability for theinitiation or implementation of a clinical investigation NOTE Whenan investigator initiates, implements and takes full responsibility forthe clinical investigation, the investigator also assumes the role ofthe sponsor and is identified as the sponsor-investigator.Subject*individual who participates in a clinical investigation NOTE Asubject can be either a healthy volunteer or a patient.Vulnerable Subject*individual whose willingness to volunteer in a clinical investigationcould be unduly influenced by the expectation, whether justified ornot, of benefits associated with participation or of retaliatoryresponse from senior members of a hierarchy in case of refusal toparticipateexample Individuals with lack of or loss of autonomy due toimmaturity or through mental disability, persons in nursing homes,children, impoverished persons, subjects in emergency situations,ethnic minority groups, homeless persons, nomads, refugees, andthose incapable of giving informed consent. Other vulnerablesubjects include, for example, members of a group with ahierarchical structure such as university students, subordinatehospital and laboratory personnel, employees of the sponsor,members of the armed forces, and persons kept in detention.* Source: ISO 14155:2011Page 14 of 23
Annex (2): Application Form for CIMDDate Received(For SFDA use only)CIMD Application Number(For SFDA use only)1. Status1.2Aim of Study Pre-marketing approval for newdevice Pre-marketing approval for newclaims Post-Marketing study Non Marketing study1.3Type of Study Observational study Interventional study1.41.5Does this clinicalinvestigation involvefirst in human use? YesWill the investigationaldevice be imported toKSA? Yes (SFDA importation license isrequired). No No2. Sponsor details2.1Type of Sponsorship Commercial Non-commercial2.2Type of sponsor manufacturer AR Hospital Independent individuals Foundation University or Institution Other, please specify: .Page 15 of 23
2.3Type of aid Material support Funding support Other, please specify: .2.4Sponsor DetailsNameSFDA’s account (if applicable)AddressPhoneFaxE- mailContact person nameContact person phoneContact person e-mail2.5Person responsible forcompleting theapplication.NamePositionPhoneE-mail3. CRO Details (if applicable)3.1CRO, if applicableNameSFDA’s license (if applicable)AddressPhoneFaxE- mailContact person nameContact person phoneContact person e-mailPage 16 of 23
4. Investigational Device Information4.1Is the device registeredat SFDA? Yes, where applicable: MDMA Certificate No. : SFDA registration No. : No, but registered in: Australia Canada Japan USA EU Other, please specify: . Not registered anywhere4.2Investigational Device Name4.3Device Category Active implantable devices Anesthetic and respiratory devices Dental devices Electro mechanical medical devices Hospital hardware Non-active implantable devices; Ophthalmic and optical devices Reusable devices Single use devices Assistive products for persons withdisability Diagnostic and therapeutic radiatingdevices Complementary therapy devices Biologically derived devices Healthcare e facility products andadaptationsPage 17 of 23
Laboratory equipment Other: .4.4Does the device is animplantable?4.5Whether the deviceintended to be used forcosmetic rather thanmedical purposes4.6Does the deviceincorporate, as anintegral part orsubstance, a medicinalproduct in achieving itsprimary intendedaction?Does the deviceincorporate a substanceof animal origin?4.74.8Does the deviceincorporate humantissue, cell, orsubstance?4.9Does the deviceincorporate cells orsubstance of microbialorigin?4.10 No Yes, brief description: . Is the device intended to remainpermanently in patient: No Yes No Yes, Select: A non-corrective contact lens An implant for augmentation,fixation, or sculpting of body parts A facial or other skin filler Equipment for liposuction Surgical laser equipment No Yes Brand name of drug: No Yes Type of tissue, cell, or substance: . No Yes Type of tissue, cell, or substance: No Yes Type of microorganism: The intended purpose of the investigational devicePage 18 of 23
5. Design of Clinical Investigation5.15.2Clinical InvestigationalPlan (CIP) informationClinical InvestigationalPlan titleScientific titleAbbreviated titleCIP numberCIP dateCIP versionPlanned start datePlanned completion date Open-label non-randomized clinicalinvestigation Randomization, Randomizedcontrolled clinical investigationo Parallel group: o Cross over: Blinding Single blinded Double blinded Other Comparator used Placebo Comparator device, identify: 5.3Type of Design5.4Does this study Noincludes vulnerable Yessubjects?5.5SizeofthesamplepopulationPlanned total number of subjectsinvolved in the clinical investigationPlanned number of subjects involved inthe KSA5.6Number of study centers in the KSA5.7Other countries where this clinical investigation is carried out5.8Is there a Data Safety YesMonitoring Committee Nofor this study?Page 19 of 23
6. Investigation Site(s) in the KSA6.1Site 1NameAddressPhoneE-mailName of principal investigatorEC nameEC addressEC phoneEC e-mailProtocol number approved by HREC/EC6.2Site 2NameAddressPhoneE-mailName of principal investigatorEC nameEC addressEC phoneEC e-mailProtocol number approved by HREC/ECAddPage 20 of 23
7. Declaration7.1I’m the sponsor defined in this application,: undertake that I comply with the Law of Ethics of Research on Living Creatures. undertake that I will report to the SFDA’s NCMDR any Adverse device effect of whichI become aware of an investigational medical; without delay but not later than 10 workingdays of occurrence. undertake that I will provide the documents specified in sections (B) and (C) of“REQUIRED DOCUMENTS” in SFDA’s guidance document entitled MDS – G20Guidance on Requirements for Clinical Investigations of Medical Devices. undertake to notify ECs and principal investigators in case of withdrawal of SFDA’sapproval, or part of it, within five working days of receiving the withdrawal notice. undertake, under any request from the SFDA to respond by providing accurate, current,and complete information about any aspects of the study. declare that SFDA has the right to inspect the study at any time without previousnotification. declare that all information provided in this application is true and complete. declare that I will maintain if applicable a proper safe return or disposal ofinvestigational devices.Name:Position:Date:Signature:Page 21 of 23
Annex (3): Disclosure of Principal Investigator Conflict of InterestsTitle of Clinical InvstigationPlanDate received:(For SFDA use only)CIMD Application Number:(For SFDA use only)I disclose the following regarding the involvement in the investigation in the submittedapplication: any significant payments of other type made from the sponsor, including but not limitedto a grant to fund ongoing research, compensation in the form of equipment, retainerfor ongoing consultation, or honoraria; any proprietary interest in the investigational product held by the clinical investigator; any considerable equity interest (including but not limited to any ownership interest,stock deal, or other financial interest) held by the clinical investigator in the sponsor ofthe covered study.Details of the disclosable financial arrangements and interests are attached, along with adescription of steps taken to minimize the potential bias of clinical study results by any of thedisclosed arrangements or interests.Name of principal investigator:Date:Signature:Note: In case of multicenter study, a separate form shall be filled for each principal investigator.Page 22 of 23
Annex (4): Change Form for CIMDDate:CIMD ApplicationNumber:1. The document typewhere the changeoccur2. The originalstatement3. The changedstatement4. Reason of changePage 23 of 23
Clinical Investigations* (of Medical Devices) (CIMD) systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device. Note: "Clinical trial" and "clinical study" are synonyms for "clinical investigation". Clinical Investigation Plan (CIP)*
Which Cisco MDS model supports the most Fibre Channel ports per chassis? A. MDS 9513 B. MDS 9509 C. MDS 9506 D. MDS 9250i Correct Answer: A QUESTION 20 Refer to the exhibit. Which Cisco MDS chassis supports the 48-Port 16-Gbps Fibre Channel Switching Module? A. MDS 9509 B. MDS 9513 C. MDS 9710 D. MDS 9506 Correct Answer: C QUESTION 21 Refer to .
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(Note: This MDS 3.0 Draft contains only the new/revised items that are being tested in the field trial. Some retained administrative items are not included in the study form in order to protect resident privacy.) DRAFT VERSION - 7/31/2006. INTRODUCTION: THE MDS 3.0 EVALUATION STUDY INTRODUCTION TO THE MDS 3.0 This revision of the Minimum Data Set for Nursing Homes (MDS 3.0) builds on lessons .
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This manual does not cover all possible MDS iNet 900 user-controllable parameters and/or diagnostic tools. For an in-depth description of all of the features and controls of the MDS iNet 900, please read the MDS iNet Network Manager’s Manual, P/N 05-xxxxA01. 2.0 PRODUCT DESCRIPTION The MDS i Net 900 transceiver, shown in Figure 1, is designed .
MDS iNET 900 Ethernet Radio four (4) 6-32 x 5/16 mounting screws power cable radio interface cable Figure 7. ControlWave Corrector / ExpressPAC / GFC Radio Installation/Mounting Diagram - MDS Radios MDS entraNET900 Access Point Radio & MDS iNET 900 Radios Figure 9. ControlWave GFC Plus Radio Installation/Mounting Diagram - MDS
