This guidance isto inform the applicants on the Clinical Evaluation of Proton and Carbon
Ion Therapy System.
This document does not fully cover the clinical evaluation data that may be necessary
to support approval. Applicants must substantiate and detail the content for clinical evaluation. If some requirements are not applicable, manufacturers must demonstrate the scientific reasons.
This guidance is not intended for administrative affairs such as registration and approval, and it is not legally enforceable. Applicants can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
The agency would need to issue updated guidance to reflect the new statutory provision, technological advances and development in standard system.
I.Scope
This guidance is for Proton/Carbon Ion Therapy System. It is classed as medical highenergy radiation therapy equipment （regulation number: 6832）according to Medical Devices Classification, version of 2002. In Medical Devices Classification, version of 2002,
it is 05 Radiation Therapy Devices, including class 1 device, Radiation Therapy Device, and
class 2 device, Medical Light Ion Therapy System. The facilities uses either cyclotron or synchrotron to accelerate the protons or carbon ions. The particle therapy system should also
refer to this guidance.
II. Basic Requirement
- General Principle
1) Description of Clinical Evaluation
Clinical evaluation is the assessment and analysis of non-clinical and clinical data pertaining to a medical device to verify its clinical safety and performance. The evaluation is
based on literature review, clinical data and clinical experience relevant to the intended use.
In clinical evaluation, the scope of application (population, site in the body, interaction
with the body, intended use, severity and stage of disease, use requirement, use environment), instructions, contraindications, precautions and warnings and other possible aspects
should be verified.
2) Qualification Requirement for Clinical Evaluation Personnel
Clinical evaluation should be conducted by qualified personnel. Credential and certificate for experience can be used to evaluate the qualification.
Generally, clinical evaluation personnel for proton/carbon ion therapy system should have:
a. Technical knowledge about proton/carbon ion therapy system and other similar systems;
—— 2 —
b. Clinical experience for proton/carbon ion therapy system such as instructions, intended
use and precautions;
c. Research methods for clinical evaluation, such as design method for clinical trial, methodology for literature review, methodology of statistics and method of efficacy evaluation.
3) Procedure of Clinical Evaluation
a. Verify technical characteristics and intended use;
b. Collect data for intended use in pre-clinical and clinical trials, post market data, domestic
use data and international use data;
c. Conduct assessment for safety and efficacy based on data;
d. Summarize all data to concluding and reporting. - Summary of Product Information
Applicants must brief the product information, and give detailed introduction for specific Essential Requirements concerning safety and efficacy, including:
1) Particle type, beam distribution(scanning orscattering), gantry type(rotating, fixed or eye
bundle), rotating scope of gantry and angle of fixed gantry;
2) Energy scope, hodoscope, Radiation field range, dose rate, spot size, Penumbra width,
beam position accuracy;
3) Treatment method;
4) Regimen of treatment: anatomical model generation of patients, dose optimization and
calculation method, biological dose model, RBE value determination;
Note: models of biological dosimetry differ by therapy system. Attention to the basis for
their identification is needed.
5) Respiratory gating and / or other management of human organ movements;
6) Image guidance (specific imaging method) and patient location verification measures
7) Special treatment techniques such as eye treatment
