January 8, 2020

Eight Class III Categories that Must Obtain Clinical Approval

As innovation devices and first-of-kind products flood into China market, NMPA seeks to strengthen the clinical-trial approval requirements for certain devices. NMPA published the Catalog of Class III Medical Devices […]
January 7, 2020

Expert Panel Guideline in China MedTech Issued

NMPA published the “Guideline on Expert Panel/ Public Advisory Meeting” on December 5, 2019. During the NMPA registration process, Expert Panel weigh the available evidence and provide scientific and medical […]
January 7, 2020
china medical device classification

About China Medical Device Classification

January 2, 2020

FDAnews Webinar: Latest Regulatory Updates with QMS-PMS Focus

Tuesday, Jan. 21, 2020, 11:00 a.m.-12:30 p.m. EST Sign up now Use VIP code VIP20 to receive 20% discount The National Medical Products Administration (NMPA) — formally known as the […]
December 31, 2019

More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical […]