September 30, 2020

China NMPA Delayed UDI Implementation Date to Jan 1st, 2021

NMPA issued a notice today to delay the UDI implementation date for the first batch of medical devices from October 1st, 2020 to January 1st, 2021. The notice adjusted both […]
September 30, 2020

Mandatory Fields for China NMPA UDI Database Filing and New Rules

Last year, NMPA issued a number of UDI related policies regarding the UDI implementation. There is a UDI database portal (https://udi.nmpa.gov.cn) established which includes sections of Filing entrance, UDI regulations, […]
September 29, 2020

NMPA on Orthopedic Device Common Issues: Mechanical Performance & Biological Evaluation

NMPA published two Q&A on orthopedic devices, addressing two frequently asked issues: Q: How to determine the mechanical performance indicators when submitting the orthopedic product technical requirements (PTR), and what […]
September 25, 2020

NMPA Cybersecurity Guideline Asks for Feedback

NMPA published “Draft Technical Guideline on Medical Device Cybersecurity” on September 8, 2020. Feedbacks need to be submitted to NMPA by October 19, 2020. It is the second version after […]
September 22, 2020

NMPA Roundup August 2020

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in August 2020. These updates are presented by China Med Device, LLC, your partner in […]
September 18, 2020

Hainan Medical Pilot Zone: Device Importation Processing Time Shortened to Three Days

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 on permission to import drugs […]
September 9, 2020

NMPA: Seven Guidelines Issued in August

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 on anti-tumor companion diagnostics (CDx) […]
September 7, 2020

Two AI Software Approved for Diabetic Retinopathy

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 technology is approved for ophthalmology […]
September 3, 2020

China UDI Database Launched: 97,258 Device Identifiers Already Uploaded

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 of devices which will take […]
August 31, 2020

China MRI Draft Guideline Published

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 manufacturers detailed pathway for clinical […]
August 21, 2020

NMPA News Roundup July 2020

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 Device, LLC, your partner in […]
August 18, 2020

NMPA on IVD Equipment and Hemodialyzer

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 change, is it necessary to […]