January 9, 2020
NMPA changed status of forty industry standards from “Mandatory” to “Recommended” in December 2019. Although both mandatory and recommended standards are not legally binding, manufacturers better to comply with them […]
January 8, 2020
Conditional Approvals with Limited Clinical Data Apply for Critical Devices, New NMPA Guideline Says
NMPA recognizes the urgent need for certain devices and IVDs. Those indicated for life-threatening illnesses can be granted Conditional Approval if the benefits of the product outweigh the risks. The […]
January 8, 2020
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
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 […]
