[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-285837-105":53,"doc-detail-285837-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","letter-of-designation-hibcc-issuing-agency","Letter of Designation - HIBCC - Issuing Agency","","This official Letter of Designation issued by the Health Sciences Authority (HSA) of Singapore formally appoints the Health Industry Business Communications Council (HIBCC) as an authorized Issuing Agency for Unique Device Identifiers (UDI) in the medical device sector. The correspondence acknowledges the receipt of the HIBCC Issuing Agency Declaration and outlines the regulatory obligations for the agency, including adherence to established criteria, reporting requirements for format changes, and prompt notification of contact updates. The document underscores the HSA's regulatory authority, including the power to review or rescind the designation should the agency fail to maintain compliance with the stipulated UDI system standards for medical devices imported, manufactured, or supplied within Singapore. This serves as a primary administrative document establishing the legal operational framework between the HSA and HIBCC.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/letter-of-designation-hibcc-issuing-agency/285837/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/letter-of-designation-hibcc-issuing-agency/285837.png","ImageObject",442,249,{"name":88,"@type":89},"Cipher","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-22","2026-09-17",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",9,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who is the issuing agency designated by the Health Sciences Authority in this letter?","Question",{"text":109,"@type":110},"The Health Industry Business Communications Council (HIBCC) is designated as an Issuing Agency for the assignment of Unique Device Identifiers (UDI).","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What is the primary responsibility of HIBCC under this designation?",{"text":114,"@type":110},"HIBCC is responsible for assigning UDI for medical devices imported, manufactured, and supplied in Singapore according to the established Medical Device Unique Device Identification system.",{"name":116,"@type":107,"acceptedAnswer":117},"What are the reporting obligations for HIBCC mentioned in the letter?",{"text":118,"@type":110},"HIBCC must notify HSA before implementing changes to the UDI format or structure and inform HSA within 7 calendar days regarding any changes in the point of contact for UDI or designation matters.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},285837,1790222614,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":9,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":4},687208528416,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Letter of Designation  \nISSUING AGENCY DESIGNATION  \nDate: 15th July 2022  \nRef No: HSA-002-HIBCC  \nDear HIBCC,  \nHealth Sciences Authority (HSA) acknowledges the receipt of your Issuing Agency Declaration dated 1st July 2022 and hereby designates Health Industry Business Communications Council (HIBCC) to act as an Issuing Agency for the assignment of Unique Device Identifiers (UDI) for medical devices imported/manufactured and supplied in Singapore.  \nThis designation letter authorizes HIBCC to assign UDI in the context of Medical Device Unique Device Identification system in Singapore.  \nYour responsibilities as a designated issuing agency includes the following:  \ni) Meeting the criteria set forth and acknowledged in the Issuing Agency Declaration dated 1st July 2022  \nii) Notifying HSA before implementing any changes to the format or structure of the UDI  \niii) Should there be a change in HIBCC point of contact with HSA pertaining to UDI or Issuing Agency Designation matters, HIBCC is obligated to inform HSA within 7 calendar days.  \nHSA reserves the right to review this designation as and when necessary. HSA may cancel this designation if the issuing agency has failed to fulfil its responsibilities or meet any of the criteria set forth in the Issuing Agency Declaration.  \nMEDICAL DEVICES CLUSTER  \nHEALTH PRODUCTS REGULATION GROUP  \nHEALTH SCIENCES AUTHORITY  \nPage 1 of 1","cbCaih7hzuMN9N04","https://ap.wps.com/l/cbCaih7hzuMN9N04","pdf",638497,"English","# Designation Overview\n## Responsibilities of the Issuing Agency\n## Regulatory Compliance and Review","[{\"question\":\"Who is the issuing agency designated by the Health Sciences Authority in this letter?\",\"answer\":\"The Health Industry Business Communications Council (HIBCC) is designated as an Issuing Agency for the assignment of Unique Device Identifiers (UDI).\"},{\"question\":\"What is the primary responsibility of HIBCC under this designation?\",\"answer\":\"HIBCC is responsible for assigning UDI for medical devices imported, manufactured, and supplied in Singapore according to the established Medical Device Unique Device Identification system.\"},{\"question\":\"What are the reporting obligations for HIBCC mentioned in the letter?\",\"answer\":\"HIBCC must notify HSA before implementing changes to the UDI format or structure and inform HSA within 7 calendar days regarding any changes in the point of contact for UDI or designation matters.\"}]","Letter of Designation - HIBCC - Issuing Agency | PDF",1789630372]