Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2025. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
Shanghai Issues New Rules for Transferring Registered Medical Devices into Local Production
The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” which takes effect on October 1, 2025.
The document specifies that eligible products must fall under Class II of the current classification rules and catalog. For registration dossier, the original materials may be reused for certain sections. However, product technical requirements and testing reports must demonstrate conformity to mandatory standards. It also introduces pre-submission services as an optional form of communication.
For more information on the Shanghai policy, please click HERE
GBA Urgent Use Policy Update: Manufacturers Encouraged to Entry Products into Pre-review Database
Guangdong government issued “Administrative Measures for the Catalog of Clinically Urgent Drugs and Medical Devices Imported from Hong Kong and Macao into the Greater Bay Area” on September 15, 2025. The framework establishes the gateway mechanism for candidate products to enter the evaluation process. Manufacturers are input the information of drugs and devices to the pre-review database, which functions as a repository of potential products to be considered for the urgent catalogue.
For more information on the document, click HERE
Guidelines & Standards
China Releases Its First Brain-Computer Interface Medical Device Terminology Standard
The NMPA recently released the industry standard YY/T 1987—2025, titled “Brain-Computer Interface Medical Equipment—Terminology”. This represents China’s first official standard dedicated to brain-computer interface (BCI) medical devices, providing a structured framework that will guide research, development, regulation, and application of BCI technologies in healthcare. For more information on the guideline, click HERE
NMPA Issues Clinical Evaluation Guideline for Cancer Screening IVDs
NMPA released the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents for Cancer Screening”. The document provides direction for applicants preparing registration dossiers and clinical evaluation materials for in vitro diagnostic (IVD) reagents used in cancer screening. It also serves as a reference for technical review departments. For more information on the guideline, click HERE
Featured Article
Hainan Policies 2025: Accelerated Market Access Pathway through RWD, Out-of-Zone Use, and Zero-Tariff Measures
Hainan Boao Pilot Zone has allowed overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China since 2020. While commercializing and selling their products, manufacturers can collect RWD through RWS in Hainan as local clinical evidence in China to support their national NMPA registration approval. The special program might fasten their China market access to 4 months.
What’s new for Hainan in 2025? Click HERE for our comprehensive review