{"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":"
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NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process.<\/p>\n

Significance of Device Guidelines<\/h4>\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

Full List<\/h4>\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