-
医疗器械注册管理办法
Medical
Devices Registration Administration Method
总则
Chapter 1 General Provisions
第一条
为规范医疗器械的注册管理，
保证医疗器械的安全、
有效，根据《医疗器械监
督管理条例》<
/p>
，制定本办法。
Article
1
To
regulate
medical
device
registration
management
and
ensure
their
safety
and
effectiveness of medical device, we set
down the management measure according to
Regulations
for the Supervision and
Administration of Medical Device.
第二条
在中华人民共和国境内销售、
使用的医疗器械均应当按照本办法
的规定申请注
册，未获准注册的医疗器械，不得销售、使用。
Article
2
All
the
medical
device
which
would
like
to
sell
and
use
within
the
territory
of
the
People’s Republic of China shall apply
for registration complying with this measure.
These medical
devices which not get
China registration approval should be prohibited
to sell and use.
第三条
医疗器械注册，
是指依照法定程序，
对
拟上市销售、
使用的医疗器械的安全性、
有效性进行系统评价，
以决定是否同意其销售、使用的过程。
Article 3
Medical device registration is the process of
doing systemic evaluation of plan-market
medical device on their safety and
effectiveness, then decide if medical device can
be allowed to
sell and use.
第四条
国家对医疗器械实行分类注册管理。
Article 4 The state shall classify
medical devices and administer them based on this
classification.
境内第一类医疗器械由设区的市级
（食品）
药品监督管理机构审查，
批准
后发给医疗器
械注册证书。
Domestic
Class
I
medical
devices
shall
be
inspected,
approved
and
granted
with
a
registration
certificate
by
the
food
drug
regulatory
authority
of
the
government
of
the
municipalities
consisting of
districts.
境内第二类医疗器械由省、自治区、直辖市（食品）药品监督
管理部门审查，批准后发
给医疗器械注册证书。
Domestic
Class
II
medical
devices
shall
be
inspected,
approved
and
granted with
a
registration
certificate
by
the
food
drug
regulatory
authorities
of
provinces,
autonomous
regions
and
municipalities directly
under the central government.
境内第
三类医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。
Domestic
Class
III
medical
device
shall
be
inspected,
approved
and
granted
with
registration
certificate by
State Food Drug Administration.
境外医疗器械由国家食品药品监督
管理局审查，批准后发给医疗器械注册证书。
Imported medical devices shall be
inspected, approved and granted with registration
certificate
by State Food Drug
Administration.
台湾、
香港、
澳门地区医疗器械的注册，
除本
办法另有规定外，
参照境外医疗器械办理。
Taiwan,
Hongkong
and
Macao’s
medical
device
registration
shall
refer
to
the
regulation
of
imported medical device.
医疗器械注册证书有效期
4
年。
Medical devices certificate is valid
for 4 years.
第五条
医
疗器械注册证书由国家食品药品监督管理局统一印制，
相应内容由审批注册
的（食品）药品监督管理部门填写。
Article
5
Medical
devices
registration
certificate
shall
be
pressed
by
State
Food
Drug
Administration
and
the
content
shall
be
filled
in
by
inspection
department
of
food
drug
administration.
注册号的编排方式为：
Registration is arranged as
the following:
×（×）
1(
食
)
药监械（×
2
）字××××
3
第×
4
××
5
××××
6
号。其
中：
X (X) 1 SFDA
(X2)
字××××
3
第×
4
××
5
××××
6
号
×
1
为注册审批部门所在地的简称：
X
1 :
Shortened form of registration
inspection department ‘s locus
境内第
三类医疗器械、
境外医疗器械以及台湾、
香港、
澳门地区的医疗器械为
“国”
字；
“国”
is for
domestic Class III medical devices, imported
medical devices and medical devices of
Taiwan, Hongkong and Macao.
境内第二类医疗器械为注册审批部门所在的省、自治区、直辖
市简称；
境内第一类医疗器械为注册审批部门所在的省、
自治区、
直辖
市简称加所在设区的市级
行政区域的简称，为××
1
（无相应设区的市级行政区域时，仅为省、自治区、直辖市的简
称）
；
×
2
为注册
形式（准、进、许）
：
“准”字适用于境内医疗器械；
“进”字适用于境外医疗器械；
“许”字适用于台湾、香港、澳门地区的医疗器械；
××××
3
为批准注册年份；
×
4
为产品
管理类别；
××
5
为产品品种编码；
×××
×
6
为注册流水号。
医疗器
械注册证书附有《医疗器械注册登记表》
（见本办法附件
1
）
，与医疗器械注册证
书同时使用。
Medical
device
registration
certificate
is
attached
with
medical
device
registration
record,
and
shall be used along with
medical device registration certificate.
第六条
生产企业提出医疗器械注册申
请，
承担相应的法律义务，
并在该申请获得批准
后持有医疗器械注册证书。
Manufacturers
put
forward
medical
device
registration
application,
take
relevant
regal
responsibility and keep medical device
registration certificate after getting application
approval.
办理医疗器械注册申请事务的人员应当受生产企业委托，
并具有相应的专业知识，
熟悉
医疗器械注册
管理的法律、法规、规章和技术要求。
Individuals who do medical device
registration application should be authorized by
manufacturer,
possess professional
knowledge, are familiar with medical device
registration administration law,
regulation, rules and technical
requirement.
申请境外医疗器械注册的，
境外生产
企业应当在中国境内指定机构作为其代理人，
代理
人应当承担相
应的法律责任；
并且，
境外生产企业应当委托中国境内具有相应
资格的法人机
构或者委托其在华机构承担医疗器械售后服务。
When doing imported medical devices
registration, the overseas manufactures shall
authorize an
unit
to
be
their
agent
in
Chinese
territory
and
the
agent
should
take
relevant
legal
responsibilities.
Meanwhile overseas manufactures shall
authorize qualified body corporate or theirs own
organ
located in China to do after
sales service.
第七条
申请注册的医疗器械，
应当有适用的产品标准，
可以采用国家标准、
行业标准
或者制定注册产品标准，
但是注册产品标准不得低于国家标准或者行业标准。
Article 7 Medical devices which
applying for registration shall have suitable
product standard that
can
adopt
state
standard,
industry
standard
or
edit
registration
standard,
but
registration
standard should not inferior to state
standard or industry standard.
注册产
品标准应当依据国家食品药品监督管理局规定的医疗器械标准管理要求编制。
Registration
standard
shall
be
edited
according
to
medical
device
standard
administration
regulation stipulated by state food
drug supervision administration.
第八条
申请第二类、
第三类医疗器械注册，
生产企业应当符合国家食品药品监督管理
局规定的生产条件或者相关质量体系要求。
Article 8 Applying for Class II and
Class III medical device registration, manufacture
shall comply
with
relevant
manufacturing
condition
or
quality
system
requirement
stipulated
by
state
food
drug supervision administration.
第二章
医疗器械注册检测
Chapter
2 Medical devices registration testing
第九条
第二类、
第三类医疗器械由国家食品药品监督管理局会同国家质量监督检验检
疫总局认可的医
疗器械检测机构进行注册检测，
经检测符合适用的产品标准后，
方可用于临
床试验或者申请注册。
Article
9
Class
II
and
Class
III
medical
devices
shall
be
tested
by
medical
device
testing
organization
approbated
by
State
Food
Drug
Supervision
Administration
and
State
Quality
Supervision Inspection and Quarantine,
then can be used in clinical trial or apply for
registration.
经国家食品药品监督管理局会同国家质量监督检验检疫总局认
可的医疗器械检测机构
（以下简称医疗器械检测机构）目录另行发布。
< br>
The
list
of
medical
device
testing
organization
approbated
by
State
Food
Drug
Supervision
Administration
and State Quality Supervision Inspection and
Quarantine (medical device testing
organization for short in the
following) shall be issued at another time.
第十条
医疗器械检测机构应当在国家
食品药品监督管理局和国家质量监督检验检疫
总局认可的检测范围内，
< br>依据生产企业申报适用的产品标准
（包括适用的国家标准、
行业标
准或者生产企业制定的注册产品标准）对申报产品进行注册检测，并出具检测报
告。
Article 10 Medical device
testing organization should do registration
testing on applicant products
according
to
available
product
standard
including
state
standard,
industry
standard
or
registration
product
standards
edited
by
manufacture
within
the
specific
testing
range
approbated
by
State
Food
Drug
Supervision
Administration
and
State
Quality
Supervision
Inspection and
Quarantine.
尚未列入各医疗器械检测机构授检范围的医疗器械，
由相应的注册审批部门指定有承检
能力的检测单位进行检测。
For
the
medical
device
that
have
not
been
listed
in
testing
range
of
all
medical
device
testing
organization
should
be
tested by
qualified
testing
united
approbated
by registration
inspection
department.
境外医疗器械的注册检测执行《境
外医疗器械注册检测规定》
。
Imported medical device registration
shall perform “Imported Medical Device
Registration Testing
Regulation”.
第十一条
同一注册单元内所检测的产品应当是能够代表本注册单元内其他产品安全
性和有效性的典型产品。
Among one
testing unit the tested product should be the
typical product that can representing
the safety and effectiveness of other
products.
第十二条
同一生产企业使用相同原材料生产的同类产品，
如果生产工艺和
预期用途保
持不变，重新注册时，对产品的生物学评价可以不再进行生物相容性试验。<
/p>
For re-registration the same
kind products which made of same material and
manufactured by
one
manufacturer
would
not
be
tested
for
biological
compatibility
item
during
biological
evaluation if manufacturing
technics and intended use do not
change.
同一生产企业使用已经通过生物学评价的原材料生产的同类产品，如果生产工艺保持不
变，
预期用途保持不变或者没有新增的潜在生物学风险，
申请注册时，
对产品的生物学评价
可以不再进行生物相容性试
验。
When register the
products which manufactured by one manufacturer,
made of same material
that have done
biological evaluation and do not change their
manufacturing technics, intended
use
and
have
no
new
potential
biological
risk
would
not
be
tested
for
biological
compatibility
during biological evaluation.
第十三条
申请第二类、
第三类医疗器械注册，
同时满足以下条件的，
可以免
予注册检
测：
Applying
for
Class
II
and
Class
III
medical
device
registration
will
be
exempted
of
doing
registration testing
if satisfy the following conditions:
（一）
所
申请注册的医疗器械与本企业已经获准注册的医疗器械的基本原理，
主要功能、
结构，所用材料、材质，预期用途属于同一类；
Applying medical device and applied
medical device is same in the basic principle,
main function,
structure, material and
intended use.
（二）
生产企业已经通过医疗器械生产质量管理规范检查或者已
经获得医疗器械质量体
系认证，并且生产企业能够提供经原企业生产条件审查机构认可的
检测报告；
The
manufacturers
have
passed
the
medical
device
manufacturing
quality
administration
regulation
testing or get approval of medical device quality
system certification, meanwhile the
manufacturers
can
provide the
admissive
testing
report
by
inspection
institution
under
former
manufacturing condition.
（三）
所申请注册的医疗器械与本企业已经获准注册并且已经通过注册检测的同类产品
比较，未发生涉及安全性、有效性改变，或者虽然涉及安全性、有效性改变，但是改变部分
和由其引起产品其他相关安全性、有效性变化的部分都已经通过了医疗器械检测机构检测；
Comparing
with
approved
registration
medical
devices
,
the
same
kind
of
applying
medical
devices
do
not
have
changes
concerning
safety
and
effectiveness
areas
or
despite
of
having
changes
concerning
safety
and
effectiveness
areas
which
have
been
tested
by
medical
device
testing institution.
（四）
已经获准注册的本企业同类产
品按照规定进行医疗器械不良事件监测，
并且未发
现严重不良事
件；
The same kind of approved
registration medical devices have not been found
adverse events in
the process of MDR.
（五）
已经获准注册的本企业同类产品
1
年内
无（食品）
药品监督管理部门产品质量监
督抽查不合格记录；<
/p>
The same kind of approved
registration medical devices have not been found
ineligible records in
the
process
of
product
quality
selective
examination
by
food
drug
supervision
administration
within one year.
（六）
境外医疗器械已经通过境外政府医疗器械主管部门的上市批准。
Overseas medical devices have got pre-
market approval by overseas medical device
supervision
government.
第十四条
申请第二类、
第三类医疗器械产品重新注册，
同时满足以下条件的，
可以免
予注册检测：
Applying
for
Class
II
and
Class
III
medical
device
re-registration
will
be
exempted
of
doing
registration testing if satisfy the
following conditions:
（一）
申请重新注册的医疗器械与本
企业已经获准注册的医疗器械的基本原理，
主要功
能、结构，所
用材料、材质，预期用途属于同一类；
Applying
re-registration medical device and applied medical
device is same in the basic principle,
main function, structure, material and
intended use.
（二）
生产企业已经通过医疗器械生产质量管理规范检查或者已
经获得医疗器械质量体
系认证，并且生产企业能够提供经原企业生产条件审查机构认可的
检测报告；
The
manufacturers
have
passed
the
medical
device
manufacturing
quality
administration
regulation
testing or get approval of medical device quality
system certification, meanwhile the
manufacturers
can
provide the
admissive
testing
report
by
inspection
institution
under
former
manufacturing condition.
（三）
申请重新注册的医疗器械与已经通过注册检测的原注册产品相比较，
未发生涉及
安全性、有效性改变，或者虽然涉及安全性、
有
效性改变，但是改变部分和由其引起产品其
他相关安全性、有效性变化的部分都已经通过
了医疗器械检测机构检测；
Comparing with
approved registration medical devices , the same
kind of applying re-registration
medical
devices
do
not
have
changes
concerning
safety
and
effectiveness
areas
or
despite
of
having
changes
concerning
safety
and
effectiveness
areas
which
have
been
tested
by
medical
device testing
institution.
（四）
申请重新注册的医疗器械在原
医疗器械注册证书有效期内按照规定进行医疗器械
不良事件监测，并且未发现不良事件；
Applying for re-
registration medical devices have not been found
adverse events in the process of
MDR
within the expiration date of the former medical
device certificate.
（五）
原注册医疗器械
1
年内无（食品）药品监督管理部门产品质量监督抽查不合格记
录。
The former approved
registration medical devices have not been found
ineligible records in the
process of
product quality selective examination by food drug
supervision administration within
one
year.
第十五条
已经通过境外政府医疗器械主管部门的上市批准、对安装场地有特殊要求、
检测困难的大
型医疗器械，
可以申请暂缓检测，
于取得医疗器械注册证书后再
对产品进行补
充检测。
Huge
medical
equipments
which
have
got
pre-market
notification
by
overseas
medical
device
supervision
department,
need
special
requirements
on
spot
installation
and
have
difficulty
for
testing can applying for postpone
testing can be done supplement testing after
getting medical
device certificate.
根据前款规定申请暂缓检测而获准注册的产品，生产企业必须在首台医疗器械入境后、
投入使用前完成注册检测。经检测合格后方可投入使用。
For the products satisfied with above
regulation that get registration approval when
applying for
postpone
testing,
the
manufacture
shall
complete
registration
testing
after
importing
the
first
medical device, until
the testing is eligible the product can be put
into use.
第三章
医疗器械临床试验
Chapter
3 Medical device clinical trial
第十六条
申请第二类、第三类医疗器械注册，应当提交临床试验资料。
When applying for Class II and Class
III medical devices registration, clinical trial
material should
be submitted.
临床试
验资料提供方式执行《医疗器械注册临床试验资料分项规定》
（见本办法附件
12
）
。
The submission methods of clinical
trial
material shall comply to ‘Medical
Device Registration on
Clinical Trial
Material Itemize Regulation’.(Refer to attachment
12)
第十七条
在中国境内进行医疗器械临床试验的，应当严格执行《医疗器械临床试验
规定》
。
The
clinical
trial
processed
in
China
shall
strictly
comply
to
‘Medical
Device
Clin
ical
Trial
Regulation’.
第十八条
在中国境内进行临床试验的医疗器械，
其临床试验资料中应当包
括临床试验
合同、临床试验方案、临床试验报告。
The
clinical
trial
material
of
medical
devices
processed
in
China
shall
include
clinical
trail
agreement, clinical
trial project and clinical trial report.
（食品）药品监督管理部门认为必要时，
可以要求生产企业提交临床
试验须知、知情同
意书以及临床试验原始记录。
Food
drug
supervision
administration
could
ask
manufacture
to
provide
clinical
trial
memorandum,
acknowledgment letter and clinical trial original
records.
第四章
医疗器械注册申请与审批
Chapter 4 Medical device registration
application and inspection
第十九条
申请医疗器械注册，
申请人应当根据医疗器械的分类，
向本办法
第四条规定
的相应
（食品）
药品监督管
理部门提出申请，
并应当填写医疗器械注册申请表，按照本办法
附件
2
、附件
3
、附件
6
、附件
8
< br>或者附件
9
的相应要求提交申请材料。申请材料应当使用
中文；根据外文资料翻译的申请材料，应当同时提供原文。
When applying for medical devices
registration, applicants shall accord with the
medical device
classification and
apply to concerning food
drug supervision administration according to item
4
of this methods.
申请人提交的医疗器械说明书应当
符合
《医疗器械说明书、
标签和包装标识管理规定》
。
Medical device user
manual submitted by applicants shall accord with
‘Administration
Regulation
of Medical Device user manual, labeling
and package '.
申请人应当对其申请材料全部内容的真实性负责。
Applicants shall take the
responsibility of the truth about the fully
application material.
第二十条
（食品）
药品监督管理部门收到申请
后，
应当根据下列情况分别作出处理：
Food
drug
supervision
administration
shall
treat
respectively
depending
on
the
following
conditions:
（一）
申请事项依法不属于本部门职
权范围的，应当即时作出不予受理的决定，并告知
申请人向有关行政机关申请；
If application articles legally
do not belong to authorized scope of this
department, should
issue
a rejection notice and advance
applicants to apply for concerning administration
unit.
（二）申请材料存在可以当场更正的错误的，应当允许申请人
当场更正；
If there is mistake in
the application material that could be correct on-
spot, the applicants shall
be permitted
to correct on spot.
（三）
申请材料不齐全或者不符合形式审查要求的，
应当当场或者在<
/p>
5
个工作日内发给
申请人《补正材料通知
书》
，一次性告知申请人需要补正的全部内容，逾期不告知的，自收
到申请材料之日起即为受理；
If
the
application
material
is
incomplete
or
not
in
accord
with
formal
inspection
requirement,
please
inform
applicant
on-
spot
or
issue
applicant
with
‘Supplement
Material
Notice
Letter’
within 5 workdays
and inform applicant all the requested
supplementary material at one time.
Without informing within appointed
period, the material receiving date should be
regarded as
the acceptance date.
（四）申请材料齐全、符合形式审查要求的，
或者申请人按照要求提
交全部补正申请材料
的，予以受理。
It
should
be
accepted
if
the
application
material
is
complete,
accord
with
formal
inspection
request
or
applicants
submit
all
requested
supplement
material
according
to
the
concerning
requirements.
（食品）
药品监督管理部门受理或者不予受理医疗器械注册申请，<
/p>
应当出具加盖本部门
专用印章并注明日期的《受理通知书》或者《
不予受理通知书》
。
Whatever
food
drug
supervision
administration
accept
medical
devices
application
or
not,
an
acceptance
notice
or
a
rejection
letter
should
be
issued
by
department
with
special
seal
and
date.
第二十一条
（食品）
药品监督管理部门受理医疗器械注册申请后，
应当在本办法第二
十二条规定的期限内对申请进行实质性审查并作出是否给予注册的书面决定。
经
审查符合规
定批准注册的，自书面批准决定作出之日起
10
个工作日内发给医疗器械注册证书。经审查
不符合规定的，
作出不予注册的书面决定，
并说明理由，
同时告
知申请人享有依法申请行政
复议或者提起行政诉讼的权利。
Food drug supervision administration
shall do substantiality inspection on application
and make a
paper decision on whether
administer registration according to the
stipulated term in item 22 of
this
method. On the condition that material accords
with inspection regulation and administer
registration, medical device
registration certificates shall be issued within
10 workdays counted
from date of the
paper approval decision-making.
第二十二条
设区的市级（食品）药品
监督管理机构应当自受理申请之日起
30
个工作
日内，作出是否给予注册的决定。
Food
Drug
regulatory
authority
of
the
government
of
the
municipalities
consisting
of
districts
shall
make
a
division
whether
to
administer
registration
within
30
workdays
from
the
date
of
application.
省、
自治
区、
直辖市（食品）药品监督管理部门应当自受理申请之日起
6
0
个工作日内，
作出是否给予注册的决定。
Food Drug regulatory
authorities of the provinces, autonomous regions
and municipalities shall
make
a
division
whether
to
administer
registration
within
60
workdays
form
the
date
of
application.
国家食品药品监督管理局应当自受
理申请之日起
90
个工作日内，作出是否给予注册的
决定。
Food Drug
regulatory authority directly under State Council
shall make a make a division whether
to
administer registration within 90 workdays form
the date of application.
<
/p>
在对注册申请进行审查的过程中，
需要检测、
专家评审和听证的，
所需时间不计算在本条规
定的期限内。
（食品）药品监督管理部门应当将所需时间书面告知申请人。
In the process of inspection, if
testing, technical review by specialists and audit
are needed, the
requested time is
besides from the regulated period of this article.
Food Drug Administration shall
inform
applicants with paper notice about the needed
time.
第二十三条
未获得境外医疗器械上市许可的境外医疗器械，
申请注册时，
参照境内同
类产品注册的技术审查要求执行（需要提交的材料见本办法附件
8
、附件
9
）
。
When
apply
for
registration,
the
imported
medical
devices
without
marketing
permission
at
overseas shall refer to registration
technical inspection requirements of the domestic
products in
the same kind (the
requested submission material shall refer to
attachment 8 and attachment 9).
第二十四条
（食品）药品监督管理部
门在对医疗器械注册申请材料进行技术审查时，
需要生产企业补充材料的，应当一次性发
出书面补充材料通知。
In
the
inspection
process
of
medical
devices
registration
application
material,
SFDA
shall
issue
paper supplementary notice to
manufacture at one time if supplementary material
is needed.
生产企业应当在
60
个工作日内按照通知要求将材料一次性补齐，补充材料的时间不计
算在
（食品）
药品监督管理部门进行实质审查的期限内。
生产企业未能在规定的时限内补充
材料且没有正当理由的，终止审查。
Manufacture
shall
submit
all
the
requested
supplementary
material
at
one
time
according
to
requirement
within
60
workdays.
The
additional
time
can
not
be
counted
to
the
SFDA’s
substantial
inspection
time.
Inspection
shall
be
discontinued
that
manufactures
do
not
supplement
the requested material within regulated time and
have no allowable reason.
第二十五条
注册申请被终止审查的，
在被终止审查后的
6
个月内不得再次申请。
For
the
discontinued
inspection,
re-registration
should
not
applied
within
6
months
from
the
discontinued date.
第二十六条
生产企业对补充材料通知
内容有异议的，可以在规定的时限内向（食品）
药品监督管理部门提出书面意见，说明理
由并提供技术支持材料，
经（食品）
药品监督管理
部门审查后作出决定。
If
manufactures have suspicion for the supplementary
material notice, a paper suggestion can be
advanced
to
SFDA
at
limited
time,
explain
excuse
and
offer
technical
supporting
material
that
shall be inspected by SFDA, finally
SFDA will give a decision.
第二十七条
医疗器械产品的注册单元
原则上以技术结构、
性能指标和预期用途为划分
依据。
Basically
the
classification
basis
of
medical
devices
registration
unit
is
technological
structure,
performance and intended use.
第二十八条
作为部件注册的医疗器械
，申请人应当说明与该部件配合使用的推荐产
品、部件的名称、型号、规格。
For medical devices registered
as parts, applicants shall explain the recommended
products, parts
name, model and
specifications to work with them.
已经获准注册的部件组合成的整机，必须履行整机注册手续。
A
complete
machine
combined
with
all
registered
parts
shall
implement
complete
unit
registration procedure.
以整机
注册的医疗器械，
申请注册时应当列出其主要配置。
如果某个主
要配置部件性能
规格发生改变，整机应当重新注册。
When medical devices
registering
as a complete
unit, its main deployment should be listed.
A
new re-
registration should be requested if the main
deployments change their performance and
specifications.
以整机注册的医疗器械，
其医疗器械注册证书附表中的
“产品性能结构及组成”
< br>栏内所
列出的组合部件在不改变组合形式和预期用途的情况下单独销售的，可以免
予单独注册。
If
the
combination
parts
which
have
been
registered
as
a
complete
unit
listed
on
column
‘performance,
structure
and
components
of
the
product’
of
the
‘Medical
D
evice
Registration
Record ’would
be allowed to exempt from sole registration when
be sold solely without changing
its
combination form and intended use.
第二十九条
（食品）
药品监督管理部门应当在行政机关的网站和医疗器械注册办公场所公
示相应的医
疗器械注册所需的条件、
程序、
期限、
需要提交的全部材料的目录和申请书示范
文本等。
SFDA shall issue the condition,
procedure, time limit, all requested material
directory, samples of
application
letters
of
medical
devices
registration
on
administrative
website
and
registration
handling area.
第三十条
（食品）
药品监督管理部门对医疗器械注册申请进行审查时，<
/p>
应当公示审批
过程和审批结果。
申请人和
利害关系人可以对直接关系其重大利益的事项提交书面意见进行
陈述和申辩。
SFDA
shall
issue
publicly
of
the
inspection
process
and
result
during
the
inspection
process
of
medical
device
application.
Applicants
and
persons
concerned
would
submit
paper
advice
to
state
and excuse for the badly concerned matter.
第三十一条
国家食品药品监督管理局
应当定期在其政府网站上公布已经获准注册的
医疗器械目录，供公众查阅。
SFDA shall regularly issue the
approved medical devices list on its government
website for public
reference.
第三十二条
医疗器械注册申请直接涉
及申请人与他人之间重大利益关系的，
（食品）
药品监督管理部
门应当告知申请人、
利害关系人可以依照法律、
法规以及国家食
品药品监督
管理局的其他规定享有申请听证的权利；在对医疗器械注册申请进行审查时，
（食品）药品
监督管理部门认为涉及公共利益的重大许可事项，
应当向社会公告，并举行听证。
第五章
医疗器械的重新注册
Chapter
5 Medical device re-registration
第三十三条
医疗器械注册证书有效期
届满，
需要继续销售或者使用医疗器械的，
生产
企业应当在医疗器械注册证书有效期届满前
6
个月内，
申请到期重新注册。
逾期办理的，
重<
/p>
新注册时应当对产品进行注册检测。
Manufacturers
shall
re-register
medical
devices
certificates
within
6
months
before
expiration
date if they would like to sell or use
medical devices with overdue certificates.
第三十四条
医疗器械注册证书中下列
内容发生变化的，
生产企业应当自发生变化之日
起
30
日内申请变更重新注册：
If any content in medical devices
certificate listing below has changed,
Manufactures shall apply
for alteration
and re-registration in 30 days from changing.
（一）型号、规格；
Specifications, models
（二）生产地址；
Manufacturing address
（三）产品标准；
Product
standards
（四）产品性能结构及组成；
Performance, structure and components
of product
（五）产品适用范围。
Indications
第三十五条
医疗器械注册证书有效期内，
产品管理类别发生改变的，
生产
企业应当在
6
个月内，按照改变后的类别到相应的（食品）药品
监督管理部门申请变更重新注册。
During
medical
device
certificate
validity
period,
if
the
administrative
catalog
changes,
manufacturers
shall
apply
for
alteration
and
re-register
according
to
the
changed
catalog
in
concerning regulatory authority of the
government.
第三十六条
申请医疗器械重新注册的，应当填写医疗器械注册申请表，并按照本办法
附件
4
、附件
5
或者附件<
/p>
7
的相应要求向（食品）药品监督管理部门提交申请材料。
When
applying
for
re-registration,
shall
fill
in
medical
device
application
form
and
submit
application material requested by this
method attachment 4,5 or 7 to SFDA.
重新注册的受理与审批程序，本章没有规定的，适用本办法第四章的相关规定。
If there is no regulation on re-
registration acceptance and inspection procedure
in this chapter,
please refer to
chapter 4 regulation.
第三十七条
有下列情形之一的医疗器械，不予重新注册：
Re-registration is not allowed for any
condition below:
（一）
未
完成（食品）
药品监督管理部门在批准上市时按照国家食品药品监督管理局有
关规定提出的要求的；
（二）经国家食品药品监督管理局再评价属于淘汰品种的；
Belong to out of date catalogs when re-
evaluated by SFDA.
（三）
按照《医疗器械监督管理条例》的规定撤销医疗器械注册证书的。
Medical device certificates that were
withdrawed by SFDA.
第六章
医疗器械注册证书的变更与补办
Alterating and Supplementing of medical
device certificates
第三十八条
医疗器械注册证书载明内容发生下列变化的，生产企业应当自发生变化之
日起
30
日内申请医疗器械注册证书变更：
Any
content
listed
in
medical
device
has
changed,
manufactures
shall
apply
for
alteration
registration on
medical device registration certificates within 30
days from the altering date.
生产企业实体不变，企业名称改变；
Manufacture substantiality does not
change, name has been altered.
生产企业注册地址改变；
Manufacture registered address has been
altered.
生产地址的文字性改变；
Literal alteration of manufacturing
address.
（四）
产品名称、商品名称的文字性改变；
Literal alteration of product name and
trade name.
（五）
型号、规格的文字性改变
；
Literal
alteration of specifications and models.
（六）
产品标准的名称或者代号的文字性改变；
Literal alteration of name or code of
product standard.
（七）
代理人改变；
Agent
changes.
（八）
售后服务机构改变。
After
sales service changes.
第三十九条
申请医疗器械注册证书变
更的，应当填写医疗器械注册证书变更申请表，
并按照本办法附件
10
的要求向原注册审批部门提交有关材料和说明。原注册审批部门对申
请材料进行形式审查，
当场或者在
5
个工作日内一次性告知申请人需要补正的全部内容，
符
合要求的发给《受理通知书》
。
Applying
for
the
alteration
registration,
should
fill
in
medical
device
registration
certificate
alteration
application
form
and
submit
concerning
material
and
explanation
to
original
registration inspection department
according to this method attachment 10. Original
registration
inspection department
shall inspect the format of material or inform
applicants with all material
requested
to supplement on spot or within 5 workdays. Submit
‘acceptance letter ’ if all material
according with requirements.
第四十条
原注册审批部门受理变更申
请后，
应当在
20
个工作日内作出是否
同意变更的
书面决定。
经审查符合规定予以变更的，
发给变更后的医疗器械注册证书，
并对原医疗器械
注册证书予以注销。
经审查不符合规定的，作出不予变更的书面决定，
< br>并说明理由，同时告
知申请人享有依法申请行政复议或者提起行政诉讼的权利。<
/p>
Original registration
inspection department shall issue a paper decision
notice on whether agree
to do
alteration registration within 20 workdays from
the date of accepting alteration application.
If
the
alteration
registration
application
is
accord
with
regulation
after
being
inspected,
registration inspection department
shall issue the altered medical device
registration certificate
and
log
out
the
original
certificate.
If
the
application
is
not
accord
with
regulation
after
being
inspected, the
department shall make a unaccepted paper notice,
explain the reason and inform
the
applicant
that
they
have
the
legal
right
of
applying
for
administrative
re-inspection
or
administrative
litigation.
变更后
的医疗器械注册证书用原编号，编号末尾加带括号的“更”字。
The
altered
medical
device
registration
certificates
would
use
the
original
number,
character
‘更’
should be attached to the
end of the number.
变更后的医疗器械注册证书的有效
期截止日与原医疗器械注册证书的有效期截止日相
同，有效期满应当申请重新注册。
The altered medical device
registration certificates shall have the same
expiration date with the
original
certificates and shall be applied for re-
registration after the expiration date .
第四十一条
医疗器械注册证书丢失或
损毁的，
生产企业应当按照本办法附件
11
的要求
提交有关材料和说明，向原注册审批部门申请补办。
If medical device registration
certificates are lost or damaged, manufactures
shall submit material
and explanation
to original registration inspection department to
apply for new transaction.
第七章
监督管理
Chapter 7
Supervision Administration
第四十二条
负责医疗器械注册审批的
（食品）药品监督管理部门应当按照规定程序进
行审批，并作出是否给予注册的决定。对
违反规定审批注册的，应当依法追究其行政责任。
Food
drug
supervision
administration
department
in
charge
of
medical
device
registration
inspection
shall
do
inspection
according
to
regulated
procedure
and
make
notice
whether
to
admit
registration. Who offend regulation shall be run
relative obligation legally.
第四十三条
设区的市级以上地方（食品）药品监督管理部门违反本办法规定实施的医疗器
械注册，
由其上级（食品）药品监督管理部门责令限期改正；逾期不改正的，上级（食品）
药品监
督管理部门可以直接公告撤销该医疗器械注册证书。
已经被撤销医疗器械注册证书的
医疗器械不得继续销售和使用，已经销售、使用的，由县级以上地方（食品）药品监督管理<
/p>
部门负责监督企业进行处理。
If
the food
drug
regulatory authority
of
the
government
above
the
municipalities
consisting
of
districts
offend
the
regulated
methods
and
shall
be
corrective
by
the
superior
food
drug
administration
department
shall
in
time
limit.
If
not
be
corrective
in
time
limit,
the
superior
would proclaim
directly to withdraw medical device certificates.
The withdraw certificates would
not be
sold or used, and the sold and used products shall
be transacted by food drug regulatory
authority above county.
第四十四条
省级以上
（食品）
药品监督管理部门对上市后的医疗器械进行技术再评价，
并根据技术评价的结果对不能达到预期使用目的、
不能保证安全有效的医疗器
械，
作出撤销
医疗器械注册证书的决定，
并向社会公告。
已经被撤销医疗器械注册证书的医疗器械不得继
续销售和使用，已经销售、使用的，由县级以上地方（食品）药品监督管理部门负责监督企
业进行处理。
Food drug
regulatory authority above province shall do
technical re-evaluation for the marketed
medical devices, and issue a notice of
withdraw their medical device certificates and
placard to
society
for
those
medical
devices
that
can
not
have
the
anticipated
usage
and
can
not
ensure
safety and
effectiveness .
第四十五条
有《中华人民共和国行政许可法》第七十条情形之一的，原注册审批部门
应当依法注销
医疗器械注册证书。
Any
situation
belongs
to
《
PRC
Administration
Admit
Law
》
item
70,
the
original
registration
inspection
department shall withdraw medical device
certificates legally.
第八章
法律责任
Chapter 8
Legal Responsibility
第四十六条
违反本办法规定，申请医疗器械注册时，采取提供虚假证明、文件、样品
等虚假材料，
或者以欺骗、
贿赂等不正当手段骗取医疗器械注册证书的，
注册审批部门不予
受理或者不予注册
,
并给予警告，
1
年内不受理其医疗器械注册
申请；
对于其已经骗取得医疗
器械注册证书，予以撤销，
2
年内不受理其医疗器械注册申请，并依照《医疗器械监督管理
条例》第四十条的规定予以处罚。
Registration inspection department
shall not accept or not admit registration and
give warning,
will
not
accept
medical
device
registration
application
within
1
year
if
there
is
any
situation
belonging to the
below: offend this regulated method, submit fake
evidence, documentation and
samples etc
when applying for medical device registration or
diddle medical device registration
certificates
by
shocking
ways
of
cheating
or
bribe.
For
the
diddled
certificates,
they
should
be
withdraw
and
would
not
applied
for
medical
device
registration
application
within
2
years,
meanwhile
will
be
punished
by
the
regulation
of
‘Medical
Device
Supervision
Administration
Regulation ’ article 40.
第四十七条
涂改、倒卖、出租、出借
医疗器械注册证书，或者以其他形式非法转让医
疗器械注册证书的，
由县级以上
（食品）
药品监督管理部门责令改正，
可以并处
3
万元以下
罚
款。
For
altering,
buying
and
selling
at
a
profit,
renting
or
borrowing
medical
device
certificates
or
other
illegally
forms
to
transfer
certificates,
food
drug
regulatory
authority
above
the
county
government shall force them to
corrective and fine under RMB30000.
第四十八条
违反本办法第三十三条、
第三十四条或者第三十五条的规定，未依法办理
医疗器械重新注册而销售的医疗器械，<
/p>
或者销售的医疗器械与注册证书限定内容不同的，
或
者产品说明书、
标签、
包装标识等内容与医疗器械注
册证书限定内容不同的，
由县级以上
（食
品）
药品监督管理部门依照
《医疗器械监督管理条例》
关于无医疗器械注册证书的处罚规定
予以处罚。
Food
drug
regulatory
authority
above
province
government
shall
punish
according
to
the
punishment
regulation
on
without
certificate
of
《
Medical
Device
Supervision
Administration
Regulation
》
for
any of the following situation, that is disobeying
article 33,34 or 35 of this method,
not
doing medical device re-registration but selling,
the sold medical devices are not same to the
limited content in the registration
certificate or products user manual, labeling,
package etc are
not same to the limited
content in the medical device registration
certificates.
第四十九条
违反本办法第三十八条的
规定，未依法办理医疗器械注册证书变更的，由
县级以上（食品）药品监督管理部门责令
限期改正或者给予警告；
逾期不改正的，
可以处以
5000
元以上
1
万元以下
罚款。
Food drug regulatory
authority above province government shall force to
corrective or warn that
violating
article 38 of this method and do not do
registration alteration. The government shall
fine above RMB5000 under RMB10000 that
exceeding the time limit.
第五十条
根据本办法第十五条申请注册后再对产品进行注册检测的医疗器械，未按照
规定完成注册检测即将产品投入使用的，由国家食品药品监督管理局撤销医疗器械注册证
书，予以公告，并记入企业诚信档案。
According
to
the
Clause
15 of
the
method,
the
product
which
applied
postponed
testing
after
receiving certificate, but to be used
before promised testing, the certificate of the
product will be
withdraw and
publicized, and the issue will be put into the
enterprise faith record.
产品经注册检测不合格的，由国家食品药品监督管理局撤销医
疗器械注册证书。
If
the
registration
testing
is
ineligible,
State
Food
Drug
Supervision
Administration
Department
shall withdraw
medical device
certificates.
第九章
附则
Chapter 9 Attachment
第五十一条
生产企业系指以自己名义
把产品推向市场，并对产品负最终法律责任的机
构。
Manufacturers mean who push product to
market and will take legal responsibility for
product.
第五十二条
注册产品系指获准注册的
医疗器械及其说明书、标签、包装标识等有关内
容与该医疗器械注册证书限定内容一致的
产品。
Registration
products
mean
the
registered
medical
device
and
medical
devices
that
their
user
manual, labeling, package etc accord
with content limited on medical device
certificate.
第五十三条
在医疗器械注册证书有效期内生产的医疗器械都视为有证产品。
Medical
devices
which
manufacture
within
the
validity
date
shall
be
regarded
as
licensed
products.
第五十四条
按医疗器械注册管理的体外诊断试剂，其注册管理规定由国家食品药品监
督管理局另行
制定。
In
vitro
agent
which
be
registered
according
to
medical
device
registration
administration,
its
registration
administration regulation shall be set separately.
第五十五条
本办法由国家食品药品监督管理局负责解释。
This method shall be explained by State
Food Drug Administration.
第五十六条
本办法自公布之日起施行
。
国家药品监督管理局于
2000
年<
/p>
4
月
5
日发布的
《医疗器械注册管理办法》同时废止。
The
regulations
shall
come
into
force
from
the
proclamation
date.
The
regulation
of
《
Medical
Device
Registration
Administration
Regulation
》
issued
at
April
5th
2000
shall
be
abolished synchronously.
附件：
Attachment:
1
．医疗器械注册登记表格式
Medical Devices Registration Record
Format
2
．境内第一类医疗
器械注册申请材料要求
Registration
applicant documentation requirements for domestic
Class I medical device
3
．境内第二类、第三类医疗器械注册申请材料要求
Registration applicant documentation
requirements for domestic Class II, III medical
device
4
．境内第一类医疗
器械重新注册申请材料要求
Re-registration
applicant documentation requirements for domestic
Class I medical device
5
．境内第二类、第三类医疗器械重新注册申请材料要求
Re-registration applicant documentation
requirements for domestic Class II, III medical
device
6
．境外医疗器械注册申请材料要求
Registration applicant documentation
requirements for overseas medical device
7
．境外医疗器械重新注册申请材料
要求
Re-registration applicant
documentation requirements for overseas medical
device
8
．未获得境外医疗
器械上市许可的第一类境外医疗器械首次注册申请材料要求
First
registration
applicant
documentation
requirements
of
overseas
Class
I
medical
device
without overseas market approval.
9
．未获得境外医疗器械上市许可的
第二类、第三类境外医疗器械首次注册申请材料要求
First
registration
applicant
documentation
requirements
of
overseas
Class
II,III
medical
device
without overseas
market approval.
10
< br>．医疗器械注册证书变更申请材料要求
Applicant documentation requirements of
medical device certificate alteration
11
．补办医疗器械注册证书申请材料要求
12
．医疗器械注册临床试验
资料分项规定
Medical device registration
clinical trial material itemized regulation
附件
1:
Attachment 1:
医疗器械注册登记表格式
Medical Devices Registration Record
Format
（一）境内医疗器械注册登记表格式：
Domestic Medical Devices Registration
Record Format
医疗器械注册登记表
Medical
Devices Registration Record Sheet
Reg
：×（×）
1
（食）药监械（准）字××××
3
< br>第×
4
××
5
< br>××××
6
号
生产企业名称
Manufacturer
企业注册地址
Company
Registration Address
生产地址
Manufacturing Address
产品名称
Product Name
型号、规格
Specification, Model
产品标准
Product Standard
产品性能结构及组成
Performance, structure and components
of the product
产品适用范围
Indications
产品禁忌症
Contraindication
备
注
Notes
××××年×月×日
（二）境外医疗器械注册登记表格式：
Overseas Medical Devices Registration
Record Format
医疗器械注册登记表
Overseas Medical Devices Registration
Record
注册号：国食药监
械（进）字××××
3
第×
4
××
5
××××
6
号
Reg No.
.
：
SFDA
（<
/p>
I
）××××
3
×
4
××
5
×
×××
6
生产企业名称
MINUFACTURER
企业注册地址
MANUFACTURER’S ADDRESS
生产地址
ADDRESS OF MANUFACTURING SITE
产品名称
NAME OF
DEVICE
型号、规格
MODEL
产品标准
PRODUCT STANDARDS
产品性能结构及组成
PERFORM
ANCE
，
STRUCTURE AND
COMPONENTS OF THE PRODUCT
产品适用范围
INDICATIONS
产品禁忌症
CONTRAINDICATIONS
代理人
AGENT
售后服务机构
SERVICE AG
ENT
（
S
）
备
注
NOTES
××××年×月×日
（三）台湾、香港、澳门地区医疗器械注册登记表格式：
Medical Devices Registration Record
Format of Taiwan, Hongkong, Macao
医疗器械注册登记表
Medical
Devices Registration Record
注册号：国食药监械（许）字××××
3
第×
4
××
5
××××
6
号
Reg No:
生产企业名称
MINUFACTURER
企业注册地址
MANUFACTURER’S ADDRESS
生产地址
ADDRESS OF MANUFACTURING SITE
产品名称
NAME OF DEVICE
型号、规格
MODEL
产品标准
PRODUCT STANDARDS
产品性能结构及组成
PERFORMANCE
，
STRUCTURE
AND COMPONENTS OF THE PRODUCT
产品适用范围
INDICATIONS
产品禁忌症
CONTRAINDICATIONS
代理人
AGENT
售后服务机构
SERVICE AG
ENT
（
S
）
备
注
NOTES
××××年×月×日
附件
2
：
Annex 2:
境内第一类医疗器械注册申请材料要求
Registration applicant material
requirement of domestic Class I medical device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration
Applying Form
（二）医疗器械生产企业资格证明：
Qualification of Medical Device
Manufacturer
营业执照副本；
Counterpart of Business License
（三）适用的产品标准及说明：
Applied product standard and
illustration
<
/p>
采用国家标准、
行业标准作为产品的适用标准的，
应当提交所采纳的国家标准、
行业标
准的文本；注册产
品标准应当由生产企业签章。
If
manufacturer adopt national standard or industrial
standard as the applied product standard,
the
manufacturer
shall
provide
concerning
copy
of
National
standard
or
industrial
standard;
Registration product standard shall be
signed/chopped by manufacturer.
生产企
业应当提供所申请产品符合国家标准、
行业标准的声明，
生产企
业承担产品上市
后的质量责任的声明以及有关产品型号、规格划分的说明。
The manufacturer shall present a
statement of compliance with the concerning
National standard
or industrial
standard, a statement that taking the quality
responsibilities of entering into market,
and a classification illustration of
concerning product models, specifications.
这里的
“签章”是指：企业盖章，或者其法定代表人、负责人签名加企业盖章（以下涉
及境内医
疗器械的，含义相同）
；
Sign/Chop refer to: enterprise chop, or
signed by the legal responsible
personnel/principal and
chop
together.(same meaning for followings domestic
medical devices)
（四）产品全性能检测报告；
Testing report for total
performance
（五）企业生产产品的现有资源条件及质量管理能力（含检测
手段）的说明；
The
illustration
for
the
manufacturing
resources
and
quality
management
abilities(testing
resources
are included.)
（六）医疗器械说明书；
Medical device user manual
（七）所提交材料真实性的自我保证声明：
Self-guarantee letter for
the authenticity of providing documents.
应当包括所提交材料的清单、生产企业承担法律责任的承诺。
It shall include the list of providing
documents, the statement of taking the legal
responsibilities
by manufacturer.
附件
3
：
Annex 3:
境内第二类、第三类医疗器械注册申请材料要求
Registration applicant material
requirement of domestic Class II, III medical
device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration
Applying Form
（二）医疗器械生产企业资格证明：
Qualification of Medical Device
Manufacturer
<
/p>
包括生产企业许可证、
营业执照副本，
并
且所申请产品应当在生产企业许可证核定的生
产范围之内；
Include manufacturing license,
Counterpart of Business License, and the applying
products falls
into the approved
manufacturing scope of manufacturing license;
（三）产品技术报告：
Product technical report
至少应当包括技术指标或者主要性能要求的确定依据等内容；
At least shall include technical
specifications or foundation of main performance
specifications;
（四）安全风险分析报告：
Safety risk analysis report
按照
YY
0316
《医疗器械风险分析》标准的要求编制。应当有能量危害、生物学危害、
环境危害、
有关使用的危害和由功能失效、
维
护不周及老化引起的危害等五个方面的分析以
及相应的防范措施；
It
shall
be
scheduled
according
to
the
requirement
of
YY0316
Device
Risk
Analyze>.
Energy hazard,
biological hazard, environmental hazard, hazard on
concerning usage and hazard
from
functional
invalidation,
culpable
maintenance
or
aging,
and
corresponding
preventative
method shall be included.
（五）适用的产品标准及说明：
Applied product standard and
illustration
采用国家标准、
行业标准作为产品的适用标准的，
应当提交所采纳的国家标准、
行业标准的
文本；注册产品标准应当由生产企业签章。
If
manufacturer
take
National
standard
or
industrial
standard
as
the applied
product
standard,
the
manufacturer
shall
provide
concerning
copy
of
National
standard
or
industrial
standard;
Registration product standard shall be
signed/chopped by manufacturer.
生产企
业应当提供所申请产品符合国家标准、
行业标准的声明，
生产企
业承担产品上市
后的质量责任的声明以及有关产品型号、规格划分的说明；
The
manufacturer
shall
present
a
statement
of
compliance
with
the
concerning
National
standard
or
industrial
standard,
a
statement
that
taking
the
quality
responsibilities
of
entering
into
market, and a classification illustration of
concerning product models, specifications.
（六）产品性能自测报告：
Self testing report on performance
产品性
能自测项目为注册产品标准中规定的出厂检测项目，
应当有主检人或者主检负责
人、审核人签字。执行国家标准、行业标准的，生产企业应当补充自定的出厂检测项目；
The tested item shall be
compliance with delivery testing item in the
registration standard, the
report
shall
be
signed
by
main
testing
personnel
or
main
testing
responsible
personnel,
and
auditor.
（七）医疗器械检测机构出具的产品注册检测报告：
Registration testing report issued by
medical device testing facility
需要进行临床试验的医疗器械，
应当提交临床试验开始前半年内由医疗器械检
测机构出具的
检测报告。
不需要进行临床试验的医疗器械，
应当提交注册受理前
1
年内由医疗器械检测
机
构出具的检测报告。
The
medical device that needs clinical trial, the
provided testing report can be issued within half
a
year
before
clinical
trail.
The
medical
device
that
needs
no
clinical
trial,
the
provided
testing
report shall be issued within one year.
执行本
办法第十一条、第十二条、第十三条、第十四条的规定的，应当提供相应的说明
文件；<
/p>
A
illustration
documents
shall
be
provide
if
Clause
11,
Clause
12,
Clause
13,
and
Clause
14
applied.
（八）医疗器械临床试验资料（具
体提交方式见本办法附件
12
）
；
Medical Device Clinical trial
material (For detailed providing method, please
refer to annex 12)
（九）医疗器械说明书；
Medical device user manual
（十）
产品生产质量体系考核（认证）的有效证明文件
——
根据对不同
产品的要求，提
供相应的质量体系考核报告：
Valid certificate of manufacturing
quality system audit---providing corresponding
quality system
audit report for
different product requirement.
1
、省、自治区、直辖市（食品）药品监督管理部门签章的、在有效期之内的体系考核
报告；
Quality system
audit report within valid period signed or chopped
by drug regulatory authorities
of
provinces, autonomous regions and municipalities
directly under the central government.
2
、医疗器械生产质量管理规范检查
报告或者医疗器械质量体系认证证书；
Medical
device
manufacturing
management
criterion
testing
report
or
medical
device
quality
system certificate.
3
、国家已经实施生产实施细则的，
提交实施细则检查验收报告；
Provide
implementary
testing
report
for
the
details
rules
if
nation
having
implemented
manufacturing
details rules.
（十一）所提交材料真实性的自我保证声明：
Self-guarantee letter for
the authenticity of providing documents.
应当包括所提交材料的清单、生产企业承担法律责任的承诺。
It
shall
include
the
list
of
providing
documents,
the
statement
of
taking
the
legal
responsibilities by manufacturer.
附件
4
：
Annex 4:
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