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CLINICAL EVALUATION REPORT
临床评估报告
For Product: XXXX
产品:
XXXX
Document No.
XXXXXXXX
文件编号
Version:
1.0
版本
:
Date: 2020-07-26
日期
:
Author:
作者
:
Reviewed by:
审阅
:
Approved by:
批准
:
<
公司
>
Table of Content
目录
Page
页码
1.
General
details
总述
..................
..................................................
........................
3
2.
Description of the device
and its intended
application
器械描述和预期用途
..
3
3.
Intended
therapeutic
and/or
diagnostic
indications
and
claims
p>
预期治疗和
/
或诊断说明和要求
........................................... ....................................
3
4.
Context
of
the
evaluation
and
choice
of
clinical
data
types
评估背景和临床数据类型的选择
.<
/p>
........................................
....................................
3
5.
Summary of the clinical data and
appraisal
总结临床数据和评价
....................
4
6.
Data
analysis
数据分析
.
..........................................
.............................................
5
6.1.
P
erformance
性能
p>
.........................................
..................................................
.....
5
6.2.
S
afety
安全
.
..................................................
..................................................
......
5
6.3.
P
roduct Literature and
Instructions for
Use
产品文献和使用说明
.
...................
5
7.
<
/p>
Conclusions
结论
.....
..................................................
..................................................
.......................................
5
1.
General details
总述
State the
proprietary name of the device and any code names
assigned during device development.
Identify the manufacturer(s) of the
device.
描述器械的商品名,以及在器械研发过程中使用的任何编码。识别器械
的生产商。
2.
Description of the device and its
intended application
器械描述和预期用途
Provide
a concise physical description of the device,
cross referencing to relevant sections of the
manufacturer
’
s
technical information as appropriate. The
description should cover information
such as:
materials, including whether it
incorporates a medicinal substance (already on the
market or new),
tissues, or blood
products;
the device
components, including software and accessories;
mechanical characteristics;
and
others, such as sterile
vs. non-sterile, radioactivity etc.
State the intended application of the
device,
single
use/reusable; invasive/non invasive;
implantable; duration of use or contact
with the body; organs, tissues or body fluids
contacted by
the device.
Describe how the device achieves its
intended purpose.
对该器械进行简明的物理描述,适当参照生产商
技术信息的相关章节。此描述应包含的信息,
如:
材料,包括是否含药(已经上市的或全新的)、组织或血液产品;
器械组成,包括软件和附件;
机械特征;和
其他,如灭菌,非灭菌,放射能等等。
描述器械的预期用途,一次性使用
/
多次使用;侵入
/
非侵入;可植入;使用持续时间或与人体接
触
;器械接触的器官,组织或体液。
描述器械如何达到它的预期用途。
3.
Intended therapeutic
and/or diagnostic indications and claims
预期治疗和
/
或
诊断说明和要求
p>
State the medical
conditions to be treated, including target
treatment group and diseases.
Outline any specific safety or
performance claims made for the device
描述使用时的医学条件,包括目标治疗群体和疾病。概述器械的任何特殊安全或性能要求。
4.
Context of
the evaluation and choice of clinical data types
p>
评估背景和临床数
据类型的选择
Outline the developmental context for
the device. The information should include whether
the
device is based on a new
technology, a new clinical application of an
existing technology, or the
result of
incremental change of an existing
technology.
The amount of
information will differ
according to
the history of the technology. Where a completely
new technology has been developed,
this
section would need to give an overview of the
developmental process and the points in the
development cycle at which clinical
data have been generated. For long standing
technology, a
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