January 9, 2020

NMPA: Industry Standards Changes in December

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

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
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About China Medical Device Classification