January 14, 2020

NMPA News Roundup December 2019

Here’s the latest NMPA news roundup, for December 2019, affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a […]
January 9, 2020

Two Class I Recalls Announced in December

NMPA announced 25 recalls in December 2019, including two Class I recalls. Class I recall (the most serious): Johnson & Johnson: Multiaxial pedicle fixation system Boston Scientific: Guiding catheter Class […]
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 […]