{"id":35087,"date":"2025-06-12T13:53:19","date_gmt":"2025-06-12T05:53:19","guid":{"rendered":"https:\/\/flcube.com\/?p=35087"},"modified":"2025-06-12T13:53:19","modified_gmt":"2025-06-12T05:53:19","slug":"nmpa-issues-immediate-guidelines-for-ngs-related-ivd-reagent-classification","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35087","title":{"rendered":"NMPA Issues Immediate Guidelines for NGS-Related IVD Reagent Classification"},"content":{"rendered":"\n<p>China&#8217;s National Medical Products Administration (NMPA) released the \u201cGuidelines for Classification Definition of Next-Generation Sequencing (NGS)-Related In Vitro Diagnostic (IVD) Reagents,\u201d effective immediately. The guidelines aim to standardize the classification and regulation of NGS-related IVD reagents.<\/p>\n\n\n\n<p><strong>Classification Details<\/strong><br>NGS-related IVD reagents are categorized into functional units, including nucleic acid extraction\/purification reagents, library construction reagents, and general sequencing reaction reagents. The guidelines specify that nucleic acid extraction\/purification reagents and general sequencing reaction reagents are classified as Class I IVD reagents. Library construction reagents are managed as Class III IVD reagents and must not be split into multiple components for registration submissions. The guidelines encourage combining general sequencing reaction reagents with library construction reagents into a single registration unit for joint application as Class III IVD reagents.<\/p>\n\n\n\n<p><strong>Requirements for Previously Registered Products<\/strong><br>For NGS-related IVD reagents previously registered as Class I before the guidelines were released, registrants must conduct self-assessments against the new requirements. Cases requiring filing modifications or cancellations shall be processed in accordance with regulations. Products no longer qualifying as Class I IVDs must be re-registered with relevant medical product authorities. Starting January 1, 2027, non-compliant reagents without proper registration certification shall be prohibited from production, importation, and sale.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s National Medical Products Administration (NMPA) released the \u201cGuidelines for Classification Definition of Next-Generation Sequencing&#8230;<\/p>\n","protected":false},"author":1,"featured_media":35088,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[22,4],"tags":[14],"class_list":["post-35087","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","category-policy-regulatory","tag-nmpa"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA Issues Immediate Guidelines for NGS-Related IVD Reagent Classification - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s National Medical Products Administration (NMPA) released the \u201cGuidelines for Classification Definition of Next-Generation Sequencing (NGS)-Related In Vitro Diagnostic (IVD) Reagents,\u201d effective immediately. 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