Part 3Class IIb medical devices

Part 3—Class IIb medical devices

<table cellspacing="0" cellpadding="0" style="width:416.05pt; border-collapse:collapse"><thead><tr><td style="width:44.4pt; 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 Item</span></p></td><td style="width:80.6pt; 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 style="width:135.75pt; 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="2" 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></tr></thead><tbody><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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>Therapeutic Goods Administration</span></p></td><td style="width:135.75pt; 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 Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part</span></p></td><td colspan="2" 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></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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>Therapeutic Goods Administration</span></p></td><td style="width:135.75pt; 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><ol class="awlist10" 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:</span></li></ol><ol class="awlist11" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:31.35pt; text-indent:-14.2pt"><span style="width:4.76pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 4 (production quality assurance procedures);</span></li></ol><ol class="awlist12" 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:</span></li></ol><ol class="awlist13" 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>Part 3 (verification procedures);</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>Part 4 (production quality assurance procedures); 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>Part 5 (product quality assurance procedures)</span></li></ol></td><td colspan="2" 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 conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part</span><span style="font-weight:normal"> </span><span style="font-weight:normal">2 of Schedule 3 to the Regulations (type examination procedures)</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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 notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="Tabletext"><span></span></p></td><td style="width:135.75pt; 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 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></p></td><td colspan="2" 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></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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 notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="Tabletext"><span></span></p></td><td style="width:135.75pt; 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="awlist14" 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:</span></li></ol><ol class="awlist15" 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 production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;</span></li></ol><ol class="awlist16" 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="awlist17" 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>an EC verification certificate issued under Annex IV of Council Directive 93/42/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>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:36pt; text-indent:-18pt"><span style="width:3pt; 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="2" 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">an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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 notified body within the meaning of Council Directive 90/385/EEC</span></p></td><td style="width:135.75pt; 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 complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC</span></p></td><td colspan="2" 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></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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 notified body within the meaning of the EU medical devices regulation</span></p></td><td style="width:135.75pt; 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="2" 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 a relevant implantable medical device—an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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 notified body within the meaning of the EU medical devices regulation</span></p></td><td style="width:135.75pt; 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:19.85pt; text-indent:-19.85pt; page-break-inside:avoid"><span>(b)</span><span style="width:8.19pt; 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:33.85pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; 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="2" 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">an EU type-examination certificate issued under Annex X of the EU medical devices regulation</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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</span><br><span>and Medical Devices Agency</span></p></td><td style="width:135.75pt; 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="awlist18" 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="2" 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="awlist19" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:25.25pt; 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></tr><tr><td style="width:44.4pt; 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 style="width:80.6pt; 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>Health Canada</span></p></td><td style="width:135.75pt; 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="2" 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 III medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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:80.6pt; 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>United States</span><br><span>Food and Drug Administration</span></p></td><td style="width:135.75pt; 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><p class="Tabletext"><span></span></p></td><td colspan="2" 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">one of the following:</span></p><ol class="awlist20" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:25.25pt; text-indent:-21.25pt"><span style="width:10.15pt; 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;</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-22.15pt"><span style="width:10.49pt; 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); or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-22.15pt"><span style="width:11.05pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></li></ol></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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:80.6pt; 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>United States</span><br><span>Food and Drug Administration</span></p></td><td style="width:135.75pt; 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 order approving an application for premarket approval under section 515 of the US FDC Act</span></p></td><td colspan="2" 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:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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>12</span></p></td><td style="width:80.6pt; 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>Health Sciences Authority of Singapore</span></p></td><td style="width:135.75pt; 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 C medical device</span></p></td><td colspan="2" 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:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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>13</span></p></td><td style="width:80.6pt; 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 UK approved body</span></p></td><td style="width:135.75pt; 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 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></td><td colspan="2" 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:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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>14</span></p></td><td style="width:80.6pt; 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 UK approved body</span></p></td><td style="width:135.75pt; 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—a production quality assurance certificate or other document issued under Annex 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:-15.95pt"><span>(i)</span><span style="width:6.51pt; 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:-15.95pt"><span>(ii)</span><span style="width:3.73pt; 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>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>a product quality assurance certificate or other document issued under Annex VI in applied Directive</span><span> </span><span>93/42</span></p></td><td colspan="2" 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:18pt"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:44.4pt; 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>15</span></p></td><td style="width:80.6pt; 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 UK approved body</span></p></td><td colspan="2" style="width:137.15pt; 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>a complete quality assurance system certificate or other document issued under section 3 of Annex 2</span><span> </span><span>in applied Directive</span><span> </span><span>90/385</span></p></td><td colspan="2" 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:18pt"><span></span></p></td></tr><tr style="height:0pt"><td style="width:55.2pt"></td><td style="width:91.4pt"></td><td style="width:146.55pt"></td><td style="width:1.4pt"></td><td style="width:120.1pt"></td><td style="width:1.4pt"></td></tr></tbody></table>