{"id":601970,"date":"2024-05-30T00:11:27","date_gmt":"2024-05-30T04:11:27","guid":{"rendered":"https:\/\/platohealth.ai\/forty-eight-guidelines-issued-in-one-day\/"},"modified":"2024-05-30T16:15:35","modified_gmt":"2024-05-30T20:15:35","slug":"forty-eight-guidelines-issued-in-one-day","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/forty-eight-guidelines-issued-in-one-day\/","title":{"rendered":"Forty-Eight Guidelines Issued in One Day","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process.<\/p>\n
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.<\/p>\n
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.<\/p>\n
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.<\/p>\n
For English version of any draft guidelines below, please email info@ChinaMedDevice.com<\/a>. We charge nominal fees for the translation. We will also give you the email and phone number of contact person that NMPA assigned for the guideline.<\/p>\n NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities. For both renewals and new registrations, […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":601973,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/601970"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=601970"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/601970\/revisions"}],"predecessor-version":[{"id":601972,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/601970\/revisions\/601972"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/601973"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=601970"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=601970"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=601970"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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