{"id":207,"date":"2014-09-20T06:15:23","date_gmt":"2014-09-20T06:15:23","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=207"},"modified":"2014-09-20T06:15:23","modified_gmt":"2014-09-20T06:15:23","slug":"australian-medical-device-registration-sponsorship","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=207","title":{"rendered":"Australian Medical Device Registration \/ Sponsorship"},"content":{"rendered":"

As you may be aware, 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.<\/span><\/p>\n

If you are an overseas manufacturer\u00a0of medical devices and you require Australian registration, let Compliance Management Solutions act as your sponsor.<\/span><\/p>\n

About CMS:<\/span><\/strong>\u00a0<\/span><\/p>\n

Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:<\/span><\/span>\u00a0<\/span><\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Implementation and maintenance of Management Systems (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Management Systems audits \u2013 (TGA\/MDD\/ISO 13485\/Sterilization\/ISO 9001)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 3rd Party Notified Body Certication Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Quotations for ISO re-certification<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Risk Management<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Continuous improvement including Corrective\/Preventive Action<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Validation including (Process\/Equipment Qualification\/Sterilization)<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Machinery\/Equipment commissioning\/installation and troubleshooting<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Complaint handling<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Process Improvement using Lean Six Sigma methodologies<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Web based compliance management software\u00a0<\/span><\/p>\n

Thank you and regards,<\/span>\u00a0<\/span><\/p>\n

George Loizou
\nCompliance Management Solutions<\/span>\u00a0<\/span><\/p>\n

E:\u00a0 <\/span>gloizou@compliancems.com.au<\/span><\/a> | M: +61 4 3312 4266
\nW: <\/span>https:\/\/compliancems.com.au<\/span><\/a><\/p>\n

\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

As you may be aware, 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:\u00a0 Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:\u00a0 \u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products) \u2022\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Implementation[…]<\/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-207","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/207","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=207"}],"version-history":[{"count":2,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/207\/revisions"}],"predecessor-version":[{"id":209,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/207\/revisions\/209"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=207"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=207"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}