{"id":236,"date":"2015-03-04T19:54:07","date_gmt":"2015-03-04T19:54:07","guid":{"rendered":"http:\/\/s4n.223.myftpupload.com\/?p=236"},"modified":"2015-03-04T19:54:07","modified_gmt":"2015-03-04T19:54:07","slug":"australian-tga-medical-device-conformity-assessment","status":"publish","type":"post","link":"https:\/\/s4n.223.myftpupload.com\/?p=236","title":{"rendered":"Australian TGA Medical Device Conformity Assessment"},"content":{"rendered":"

As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). <\/span>
\n Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies – what the Australian medical device industry has been pushing for for quite some time now has finally come to fruition.<\/p>\n

This means that Australian MD manufacturers will no longer require TGA Conformity Assessment to manufacture and sell medical devices here in Australia; European EC Certificates will now be accepted (class dependant).<\/p>\n

For more information on this regulatory change contact Compliance Management Solutions.<\/p>\n

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

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

\u00d8<\/span> Australian ARTG registration\/sponsorship\/consultancy (medical devices\/medicinal products) <\/span><\/span>
\n\u00d8<\/span> Implementation and maintenance of Management Systems (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span>
\n\u00d8<\/span> Management Systems audits \u2013 (MDD\/ISO 13485\/Sterilization\/ISO 9001) <\/span><\/span>
\n\u00d8<\/span> 3rd Party Notified Body Certification Audits (MDD\/ISO 13485\/ISO 9001\/ISO 22716) <\/span><\/span>
\n\u00d8<\/span> Quotations for ISO transfer of certificate <\/span><\/span>
\n\u00d8<\/span> Risk Management <\/span><\/span>
\n\u00d8<\/span> Continuous improvement including Corrective\/Preventive Action <\/span><\/span>
\n\u00d8<\/span> Validation including (Process\/Equipment Qualification\/Sterilization) <\/span><\/span>
\n\u00d8<\/span> Machinery\/Equipment commissioning\/installation and troubleshooting <\/span><\/span>
\n\u00d8<\/span> Complaint handling <\/span><\/span>
\n\u00d8<\/span> Process Improvement using Lean Six Sigma methodologies <\/span><\/span>
\n\u00d8<\/span> Web based compliance management software <\/span><\/span>
\n
\nCompliance Management Solutions
\nMelbourne, Australia<\/p>\n

E: gloizou@compliancems.com.au | M: 0433 12 42 66
\nW: www.compliancems.com.au<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies – what the Australian medical device industry has […]<\/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-236","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/posts\/236","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=236"}],"version-history":[{"count":2,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/posts\/236\/revisions"}],"predecessor-version":[{"id":238,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=\/wp\/v2\/posts\/236\/revisions\/238"}],"wp:attachment":[{"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=236"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=236"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/s4n.223.myftpupload.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}