Category: NMPA (CFDA) Updates

The NMPA granted innovation approvals to Medtronic’s renal denervation device and issued a review report. This is the sixth report published this year for imported devices, after those from Medtronic

The NMPA granted innovation approval to Ivantis, Inc.’ hydrus microstent and issued a review report. This is the fifth report published for overseas manufacturers, after Medtronic, CarboFix Orthopedics, Intuitive Surgical

The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57 Class III, 101 Class II

The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report. These published review reports serve as important references

NMPA published the twelve guidelines (IVD Guidelines) for in vitro diagnostic reagents-related products on January 3, 2024. It comes as File No.1 released by NMPA CMDE (Center for Medical Device

In October 23, a total of 221 medical device products were approved by China National Medical Product Administration (NMPA). Among them, there are 176 domestic Class III medical device products,

NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024. For an English copy of any guideline below, please email info@ChinaMedDevice.com.

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by China Med Device, LLC, your partner

NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023. What’s the Device In the approval notice, NMPA says that “the product consists of a scanning