{"id":"https://openalex.org/W801973812","doi":"https://doi.org/10.3233/978-1-61499-538-8-23","title":"Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work","display_name":"Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work","publication_year":2015,"publication_date":"2015-01-01","ids":{"openalex":"https://openalex.org/W801973812","doi":"https://doi.org/10.3233/978-1-61499-538-8-23","mag":"801973812","pmid":"https://pubmed.ncbi.nlm.nih.gov/26152943"},"language":"en","primary_location":{"id":"doi:10.3233/978-1-61499-538-8-23","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-538-8-23","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5054702209","display_name":"Khaled Al\u2013Surimi","orcid":"https://orcid.org/0000-0002-7845-258X"},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Al-Surimi Khaled","raw_affiliation_strings":["College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia"],"affiliations":[{"raw_affiliation_string":"College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057926319","display_name":"Mowafa Househ","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Househ Mowafa","raw_affiliation_strings":["College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia"],"affiliations":[{"raw_affiliation_string":"College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075008365","display_name":"Essam Almohandis","orcid":null},"institutions":[{"id":"https://openalex.org/I28513355","display_name":"Saudi Arabian Monetary Authority","ror":"https://ror.org/02a0n8d86","country_code":"SA","type":"government","lineage":["https://openalex.org/I28513355"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Almohandis Essam","raw_affiliation_strings":["Saudi Food and Drug Authority, Riyadh, Saudi Arabia"],"affiliations":[{"raw_affiliation_string":"Saudi Food and Drug Authority, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I28513355"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5021502243","display_name":"Fahd Alshagathrh","orcid":null},"institutions":[{"id":"https://openalex.org/I28513355","display_name":"Saudi Arabian Monetary Authority","ror":"https://ror.org/02a0n8d86","country_code":"SA","type":"government","lineage":["https://openalex.org/I28513355"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Alshagathrh Fahd","raw_affiliation_strings":["Saudi Food and Drug Authority, Riyadh, Saudi Arabia"],"affiliations":[{"raw_affiliation_string":"Saudi Food and Drug Authority, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I28513355"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5054702209"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":6.2647,"has_fulltext":false,"cited_by_count":6,"citation_normalized_percentile":{"value":0.93867925,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":"213","issue":null,"first_page":"23","last_page":"6"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.975600004196167,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.975600004196167,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9297999739646912,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T14293","display_name":"Biotechnology and Related Fields","score":0.9290000200271606,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/work","display_name":"Work (physics)","score":0.6045523285865784},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.49387794733047485},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.4462241530418396},{"id":"https://openalex.org/keywords/decree","display_name":"Decree","score":0.44324642419815063},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.4251045286655426},{"id":"https://openalex.org/keywords/health-surveillance","display_name":"Health surveillance","score":0.4130387306213379},{"id":"https://openalex.org/keywords/medical-emergency","display_name":"Medical emergency","score":0.37756621837615967},{"id":"https://openalex.org/keywords/environmental-health","display_name":"Environmental health","score":0.24168109893798828},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.20724061131477356},{"id":"https://openalex.org/keywords/geography","display_name":"Geography","score":0.14124378561973572}],"concepts":[{"id":"https://openalex.org/C18762648","wikidata":"https://www.wikidata.org/wiki/Q42213","display_name":"Work (physics)","level":2,"score":0.6045523285865784},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.49387794733047485},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4462241530418396},{"id":"https://openalex.org/C2778958867","wikidata":"https://www.wikidata.org/wiki/Q2571972","display_name":"Decree","level":2,"score":0.44324642419815063},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4251045286655426},{"id":"https://openalex.org/C2992558043","wikidata":"https://www.wikidata.org/wiki/Q30671664","display_name":"Health surveillance","level":2,"score":0.4130387306213379},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.37756621837615967},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.24168109893798828},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.20724061131477356},{"id":"https://openalex.org/C205649164","wikidata":"https://www.wikidata.org/wiki/Q1071","display_name":"Geography","level":0,"score":0.14124378561973572},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C78519656","wikidata":"https://www.wikidata.org/wiki/Q101333","display_name":"Mechanical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C166957645","wikidata":"https://www.wikidata.org/wiki/Q23498","display_name":"Archaeology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012529","descriptor_name":"Saudi Arabia","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012529","descriptor_name":"Saudi Arabia","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012529","descriptor_name":"Saudi Arabia","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D033181","descriptor_name":"Information Dissemination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D033181","descriptor_name":"Information Dissemination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D033181","descriptor_name":"Information Dissemination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":false},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":false},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.3233/978-1-61499-538-8-23","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-538-8-23","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},{"id":"pmid:26152943","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/26152943","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in health technology and informatics","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.44999998807907104,"id":"https://metadata.un.org/sdg/17","display_name":"Partnerships for the goals"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2378754580","https://openalex.org/W2357292978","https://openalex.org/W69874411","https://openalex.org/W4399630031","https://openalex.org/W2275624268","https://openalex.org/W1542589285","https://openalex.org/W4394782669","https://openalex.org/W1526834201","https://openalex.org/W4319593530","https://openalex.org/W4299326138"],"abstract_inverted_index":{"Medical":[0,95,124],"device":[1,49,55,103,145],"evaluation":[2],"presents":[3],"several":[4],"unique":[5],"challenges":[6],"due":[7],"to":[8,81,100,106,118],"the":[9,31,45,67,75,82,91,94,123,134],"great":[10],"diversity":[11],"and":[12,17,37,52,65,85,110,132,137,147],"complexity":[13],"of":[14,27,33,47,114,140],"medical":[15,48,54,79,102,144],"devices":[16,80],"their":[18],"rapid":[19],"technological":[20],"evolution.":[21],"There":[22],"has":[23],"been":[24],"a":[25,71,142],"variety":[26],"work":[28,139],"conducted":[29],"on":[30,122],"development":[32],"disease":[34],"based":[35],"registries":[36],"health":[38],"surveillance":[39,56,149],"systems":[40,51,57],"in":[41,59,62,129,151],"Saudi":[42,63,83,130,152],"Arabia.":[43,153],"However,":[44],"progress":[46],"registry":[50,146],"post-market":[53,148],"remains":[58],"its":[60],"infancy":[61],"Arabia":[64,131],"within":[66],"region.":[68],"In":[69],"2007,":[70],"royal":[72],"decree":[73],"assigned":[74],"responsibility":[76],"for":[77],"regulating":[78],"Food":[84],"Drug":[86],"Authority":[87],"(SFDA).":[88],"Soon":[89],"afterwards,":[90],"SFDA":[92],"established":[93],"Devices":[96],"National":[97,126],"Registry":[98,127],"(MDNR)":[99,128],"house":[101],"information":[104],"relating":[105],"manufacturers,":[107],"agents,":[108],"suppliers":[109],"end-users.":[111],"The":[112],"aim":[113],"this":[115],"paper":[116],"is":[117],"provide":[119],"an":[120],"overview":[121],"Device":[125],"describe":[133],"current":[135],"experience":[136],"future":[138],"establishing":[141],"comprehensive":[143],"system":[150]},"counts_by_year":[{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":1},{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":2},{"year":2017,"cited_by_count":1}],"updated_date":"2025-11-06T03:46:38.306776","created_date":"2025-10-10T00:00:00"}
