{"id":19569,"date":"2023-04-17T10:47:00","date_gmt":"2023-04-17T02:47:00","guid":{"rendered":"https:\/\/flcube.com\/?p=19569"},"modified":"2024-12-24T10:53:09","modified_gmt":"2024-12-24T02:53:09","slug":"nhc-proposes-updates-to-access-standards-for-class-a-and-b-medical-equipment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=19569","title":{"rendered":"NHC Proposes Updates to Access Standards for Class A and B Medical Equipment"},"content":{"rendered":"\n<p>The National Healthcare Commission (NHC) has released two proposed updates to the Access Standards for Large Medical Equipment, which will impact Class A and Class B devices. These updates are currently open for public comments, allowing stakeholders to provide feedback on the proposed changes.<\/p>\n\n\n\n<p><strong>Details of the Proposed Updates<\/strong><br>As per the documents, Class A large medical equipment encompasses heavy ion proton radiotherapy systems and high-end radiotherapy equipment. Class B includes positron emission magnetic resonance imaging systems (PET\/MR), X-ray positron emission tomography scanners (PET\/CT), abdominal endoscopic surgery systems, and conventional radiation therapy equipment. The new version of the access standards has seen a reduction in requirements related to functional positioning, technical conditions, supporting facilities and equipment compared to the 2018 version, while the demand for clinical services remains largely unchanged.<\/p>\n\n\n\n<p><strong>Recent Policy Developments<\/strong><br>Last month, the NHC published the &#8220;Catalogue for the Management of Large Medical Equipment Configuration Licenses (2023).&#8221; This update has reduced the number of management items from 10 to 6, with Class A items decreasing from 4 to 2 and Class B items from 6 to 4. This adjustment is in line with the government&#8217;s initiative to &#8220;streamline administration, delegate power, and improve services.&#8221; For equipment with mature technology, stable performance, and standardized application, there is a proactive push to change its classification from Class A to Class B or to remove it from the Class B category altogether.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The National Healthcare Commission (NHC) has released two proposed updates to the Access Standards for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[22,4],"tags":[60],"class_list":["post-19569","post","type-post","status-publish","format-standard","hentry","category-medical-device","category-policy-regulatory","tag-nhc-nhfpc"],"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>NHC Proposes Updates to Access Standards for Class A and B Medical Equipment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Healthcare Commission (NHC) has released two proposed updates to the Access Standards for Large Medical Equipment, which will impact Class A and Class B devices. 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