CMD Blogs

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by

The NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on

NMPA granted Innovation Approval to the Colorectal Cancer Detection Kit, Combination Detection Kit for KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and FOBT (PCR fluorescent

NMPA announced the Procedure of Dynamic Amendment of Medical Device Classification Catalogue (Draft) on November 13, 2020, providing a more risk-based and internationally recognized pathway

NMPA granted Innovation Approval designation to eight medical devices on November 2, 2020. Complete List Product Name Manufacturer Pulsed Field Ablation System Medtronic, Inc. Bronchus

Here are the latest NMPA regulatory and clinical affairs news articles in October 2020 for medical devices and IVDs pros. These updates are presented by

The NMPA released the IMDRF (International Medical Device Regulators Forum) draft document of “PMCF (Post-Market Clinical Follow-Up) Studies” on October 22, 2020. The proposed document

Electronic signature, certificate and documents have gained popularity due to higher efficiency and availability overseas. Submission Material Electronic Signature NMPA issued a release called “Matters

With an announcement on October 20, 2020, the NMPA reclassified 29 cancer biomarker-related reagents from Class III to Class II. Additionally, they modified its intended

Thirty four industry standards for medical devices were issued by the NMPA on October 22, 2020. These were put in place to guide manufacturers for

The NMPA issued a notice called “the Establishment of Medical Robotics Standardization Agency” on September 27. This is announcing the regulatory preparation for medical robotics.

NMPA granted priority review designation to CooperVision and Biomerieux on September 30, and gave its reason as below: Soft hydrophilic contact lens, by CooperVision, on