CMD Blogs

Hainan government published “The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”, unveiling first-of-its-kind policies

NMPA published seven pathology and clinical chemistry guidelines in August, to direct manufacturers for clinical trial, local type testing and regulatory approval: Clinical trial guideline

NMPA granted Innovation Approvals of two diabetic retinopathy (DR) assistant diagnosis software, to Shenzhen Guiji and Shanghai Yingtong. It is the first time that AI

NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group

NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging (MRI) System Comparing the Similar Device (draft)” on August 13, 2020. The 19-page document provides

Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros for July 2020. These updates are presented by China Med

NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues: Q: When applying for an in vitro diagnostic equipment registration

NMPA issued fourteen guidelines in July. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia, and immunology, etc. Full List of Guidelines General

The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy,

NMPA granted Fast-Track Status to two medical device manufacturers in July: Innovation approval status: Clinical Chemistry Shenzhen Guiji Chuangan: continuous glucose monitor Priority review status:

NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. It is an effort to implement

A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative