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 important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients’ specific products to gain more clarity and be more efficient in their submission and approval process. As NMPA standardizes and streamlines the review process for fast-track approval, domestic and overseas players can benefit from our expertise and experience.
Product overview
- Product structure and composition
- Intended Use
This product is intended to deliver proton beams for radiotherapy and is suitable for treating malignant solid tumors throughout the body as well as certain benign conditions. Specific indications should be determined by the clinician based on the actual circumstances.
- Model/Specification
- Working principle
The product generates protons using an ion source, which are then accelerated by a cyclotron. When the proton energy reaches 230 MeV, the beam is extracted through the beam extraction unit and delivered to the treatment subsystem for radiotherapy.
The product includes a treatment room, where the treatment control system executes patient treatment plans by precisely controlling and delivering the proton beam point by point and layer by layer, using pencil beam scanning combined with a range modulator. With the support of an image guidance system, rotating gantry, laser positioning system, and patient support system, it ensures precise irradiation of the patient’s target area.
Pre-clinical
The product underwent extensive performance research, biocompatibility assessment, sterilization guidelines, software evaluation, and compliance testing to ensure safety and efficacy.
- Performance Research
The applicant defined technical requirements, including beam performance, image guidance, laser positioning, respiratory gating, multi-leaf collimator, treatment planning, and control systems, following guidelines such as YY/T 1763-2021 and YY 1650-2019. Product performance and testing data were submitted, meeting technical standards.
- Biocompatibility
The product involves short-term skin contact and passed evaluations based on GB/T 16886.1-2011, confirming acceptable biocompatibility risk.
Sterilization
Periodic surface disinfection of components is required, with methods specified in the user manual.
- Product Lifespan and Packaging
The product has a validated lifespan of 20 years, supported by strength analysis, fatigue testing, and supplier data.
- Software Research
The product includes four software components: the proton therapy system, treatment console (TC), image-guided registration software (Verity), and radiotherapy planning system (RayStation). Each meets strict safety standards and follows 2022 Medical Device Software Registration Guidelines for design, development, and cybersecurity, with acceptable residual risks.
- Safety Standards
The product complies with mandatory safety standards, including GB 9706.1-2020, GB 9706.103-2020, and others for electrical safety, radiation protection, and electromagnetic compatibility. Specific safety and performance requirements for X-ray and ion beam therapy devices, such as YY 9706.268-2022, are also fulfilled.
These evaluations and compliance measures demonstrate that the product meets stringent regulatory and performance standards.
Clinical
The clinical trial aimed to evaluate the safety and efficacy of the product for radiotherapy in cancer treatment. The study utilized a retrospective, multi-center, open-label, single-arm design.
- Inclusion and Exclusion Criteria
Key inclusion criteria included patients aged 18–80 diagnosed with tumors in the head and neck, chest, abdomen, spine, or pelvis, treated with the product before December 31, 2022. Exclusion criteria included prior radiotherapy for the same tumor, concurrent anti-cancer treatments during the study, or other conditions deemed unsuitable by investigators.
- Study Population
A total of 121 participants were enrolled: 32 with head and neck tumors, 32 with chest tumors, 55 with pelvic tumors, and 2 with spinal tumors.
- Efficacy Endpoints
The primary efficacy endpoint was the local control rate (LCR) at 12 months post-treatment, which reached 85.95% (95% CI: 79.76–92.14%). Secondary endpoints included LCR at 3 months (91.26%) and 6 months (88.57%), overall survival rate at 12 months (90.77%), and progression-free survival rates at 3, 6, and 12 months (95.78%, 94.93%, and 84.71%, respectively).
- Safety Endpoint
Acute toxicity rates at 3 months were: Grade 1–3 at 57.02%, 42.15%, and 4.13%, respectively. Late toxicity rates were: Grade 1–3 at 36.36%, 13.22%, and 4.96%. No Grade 4 or 5 toxicity was observed.
The trial demonstrated promising safety and efficacy outcomes for the product.
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