{"id":243,"date":"2015-03-04T20:01:41","date_gmt":"2015-03-04T20:01:41","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=243"},"modified":"2015-03-04T20:01:41","modified_gmt":"2015-03-04T20:01:41","slug":"tga-australian-medical-device-sponsor-2","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=243","title":{"rendered":"TGA Australian Medical Device Sponsor"},"content":{"rendered":"<p>As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia.<\/p>\n<p>If you are an overseas manufacturer\u00a0of medical devices and you require Australian registration, let Compliance Management Solutions act as your sponsor.<\/p>\n<p><span style=\"font-family: Calibri; font-size: medium;\">About CMS: <\/span><\/p>\n<p><span style=\"color: #000000; font-family: Calibri; font-size: medium;\"> Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA\/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: <\/span><\/p>\n<p><span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products) <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Implementation and maintenance of Management Systems (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Management Systems audits \u2013 (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> 3rd Party Notified Body Certification Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716) <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Quotations for ISO transfer of certificate <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Risk Management <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Continuous improvement including Corrective\/Preventive Action <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Validation including (Process\/Equipment Qualification\/Sterilization) <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Machinery\/Equipment commissioning\/installation and troubleshooting <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Complaint handling <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Process Improvement using Lean Six Sigma methodologies <\/span><\/span><br \/>\n<span style=\"font-size: medium;\"><span style=\"font-family: Symbol;\">\u00d8<\/span><span style=\"font-family: Calibri;\"> Web based compliance management software <\/span><\/span><br \/>\n<span style=\"color: #000000; font-family: Calibri; font-size: medium;\"><br \/>\nCompliance Management Solutions<br \/>\nMelbourne, Australia<\/p>\n<p>E: gloizou@compliancems.com.au | M: 043312 4266<br \/>\nW: https:\/\/compliancems.com.au<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer\u00a0of medical devices and you require Australian registration, let Compliance Management Solutions act as your sponsor. About CMS: Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA\/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: \u00d8 Australian[&#8230;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-243","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/243","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=243"}],"version-history":[{"count":2,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/243\/revisions"}],"predecessor-version":[{"id":245,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/243\/revisions\/245"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=243"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=243"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=243"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}