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Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
<table cellspacing="0" cellpadding="0" style="width:417.4pt; border-collapse:collapse"><thead><tr><td style="width:44.15pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Item</span></p></td><td colspan="2" style="width:80.05pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td colspan="2" style="width:135.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="3" style="width:110.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span>Column 4</span></p><p class="TableHeading" style="margin-left:5.45pt"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr></thead><tbody><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:</span></p><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(a)</span><span style="width:9.4pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>Part 4 (production quality assurance procedures);</span></p><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(b)</span><span style="width:8.84pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state:</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>Part 3 (verification procedures);</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(iii)Part 4 (production quality assurance procedures); or</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(iv)Part 5 (product quality assurance procedures)</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="TableHeading"><span style="font-weight:normal"></span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(a)</span><span style="width:9.4pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:</span></p><ol class="awlist1" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or</span></li><li class="Tabletext" style="margin-left:31.35pt; text-indent:-14.2pt"><span style="width:1.98pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;</span></li></ol><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(b)</span><span style="width:8.84pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:</span></p><ol class="awlist2" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36.1pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt"><span style="width:1.93pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt; list-style-position:inside"><span style="width:2.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt; list-style-position:inside"><span style="width:3.46pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of Council Directive 90/385/EEC</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><ol class="awlist3" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:</span></li></ol><ol class="awlist4" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;</span></li></ol><ol class="awlist5" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:</span></li></ol><ol class="awlist6" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:3pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of the EU medical devices regulation</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of the EU medical devices regulation</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(ii)</span><span style="width:3.73pt; text-indent:0pt; display:inline-block"> </span><span>an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:26.05pt"><span style="font-weight:bold"></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Japan’s Ministry</span><br><span>of Health, Labour and Welfare or</span><br><span>the Japanese Pharmaceuticals and Medical Devices Agency</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><ol class="awlist7" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a MDSAP certificate; or</span></li><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">either of the following:</span></p><ol class="awlist8" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market certification issued under the Japanese PMD Act; or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market approval issued under the Japanese PMD Act</span></li></ol></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Health Canada</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169446516"><span>a MDSAP certificate</span></a></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">a Class II medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">United States</span><br><span style="font-weight:normal">Food and Drug Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">for medical devices that are not exempted, by the United States Food and Drug Administration, from section 510(k) requirements—either of the following:</span></p><ol class="awlist9" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a determination of substantial equivalence made with respect to a notification submitted under section</span><span> </span><span>510(k) of the US FDC Act; or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order granting a request for classification under section 513 of the US FDC Act (a</span><span> </span><span>De Novo classification request)</span></li></ol></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8A</span></p></td><td colspan="3" style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">United States Food</span><span style="font-weight:normal"> </span><span style="font-weight:normal">and Drug Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">for medical devices that are exempted, by the United States Food and Drug Administration, from section 510(k) requirements—a statement that includes the device name or description, regulation number and submission type under United States Food and Drug Administration requirements</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Health Sciences Authority of Singapore</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal"></span></p></td><td style="border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; vertical-align:top"></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:79.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a UK approved body</span></p></td><td colspan="5" style="width:140pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state—either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section 4 of that Annex;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex</span><span> </span><span>V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section</span><span> </span><span>4 of that Annex;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a verification certificate of conformity issued under Annex</span><span> </span><span>IV in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex</span><span> </span><span>V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iv)</span><span style="width:0.91pt; text-indent:0pt; display:inline-block"> </span><span>a product quality assurance certificate or other document issued under Annex</span><span> </span><span>VI in applied Directive</span><span> </span><span>93/42</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal"></span></p></td></tr><tr style="height:453pt"><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:79.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a UK approved body</span></p></td><td colspan="5" style="width:140pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state—either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex</span><span> </span><span>2 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex</span><span> </span><span>5 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section</span><span> </span><span>3 of Annex</span><span> </span><span>2 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a verification certificate of conformity issued under Annex</span><span> </span><span>4 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex</span><span> </span><span>5 in applied Directive</span><span> </span><span>90/385</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal"></span></p></td></tr><tr style="height:0pt"><td style="width:54.95pt"></td><td style="width:90.15pt"></td><td style="width:0.7pt"></td><td style="width:0.45pt"></td><td style="width:146.05pt"></td><td style="width:0.45pt"></td><td style="width:3.15pt"></td><td style="width:117.9pt"></td><td style="width:0.45pt"></td><td style="width:3.15pt"></td></tr></tbody></table>