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2026 China NMPA Bluebook is here:
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local type testing or significant burden
The Health Commission of Guangdong Province, together with the provincial healthcare security and medical products authorities, has jointly announced the first batch of pilot hospitals for international medical services. A
The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be
The NMPA granted innovation approval to Mevion Medical System’s proton therapy system and issued a review report on December 4, 2025. The published review reports like this one serve as
The NMPA granted innovation approval to Boston Scientific Neuromodulation’s DBS directional lead and issued a review report on November 6. The published review reports like this one serve as important
NMPA published the “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings” on July 19, 2024. It green lights the urgent importation and use of
The NMPA granted innovation approvals to Intuitive Surgical’s bronchial navigation system and issued a review report. These published review reports serve as important references for you to understand what the
NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices. These published review reports serve as important references for you to understand what
The NMPA granted Innovation Approval to five medical devices in November 2023, including two additive manufactured devices: For an English copy of the “Tech Guide on Customized Additive Manufactured (3D
The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report. It is the seventh imported innovative device approved by the
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so far in 2023, after Medtronic,
NMPA granted innovation approval to Varian’s Proton Therapy System on November 1, 2023. What’s the Device This product consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem