Medical Devices

NMPA legal agents shall formulate risk control measures due to raw material changes during the manufacturing process of passive medical devices.

NMPA granted fast-track approval to Novocure's Optune, the first overseas innovative medical device to treat glioblastoma in China.

NMPA published a notice addressing the work items for medical device sampling inspection, reinspection, objections and appeals, etc.

The NMPA drafted a guidance document to include human factors/usability engineering (HFE) for the registration of medical devices.

The Standardization Administration of China released the GB 9706.1-2020 addressing new safety and performance requirements for medical electrical equipment.

Once a medical device is approved for use within the Pilot Zone, hospitals can use a special pathway to apply for NMPA registration in China.

NMPA solicites public opinions on the draft proposal to reclassify IVD reagents in the 6840 Classified Subdirectory (2013 Version).

The UDID was officially released to the public, allowing users to use the search tool, download, and data sharing features.

Hainan MPA utilizes real-world data application and other measures to enhance the healthcare industry development in the Hainan Free Trade Zone.

The NMPA made temporary rearrangements for the submission of notarized documents for medical device registration applications due to the COVID-19 outbreak.

Exporting coronavirus protection supplies in China requires the declaration of conformity and the overseas product registration certificate.

In response to the coronavirus epidemic, NMPA guides the suitable pathway for the registration application of different types of medical supplies in China.