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<p class="MsoBodyText"><span lang="EN-GB">This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).</span></p>
Reģistrācijas numurs (WIID)
85837
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).</span></p>
