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temporarily英文版《医疗器械经营监督管理办法》(国家食品药品监督管理总局局令第8号)en

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2021-01-21 11:16
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2021年1月21日发(作者:composition)
Measures for the Supervision and Management of Medical Device Operation


Chapter I

General Principles
Article 1


These measures are specially formulated to strengthen the supervision and
management
of
medical
device
operation,
standardize
the
operating
behaviors
of
medical
devices,
and
guarantee
the
safety
and
validity
of
medical
devices
in
accordance
with
the
Regulations
on
the
Supervision
and
Administration
of
Medical
Devices
.
Article
2

The
operating
activities
and
their
supervision
and
management
of
the
medical
devices
dealt
with
within
the
territory
of
the
People's
Republic
of
China
should be governed by these measures.
Article 3


China Food and Drug Administration shall be in charge of the supervision
and
management
of
the
medical
device
operation
nationwide.
The
food
and
drug
administration department above county level shall be responsible for the supervision
and management on the medical device operation within respective jurisdiction.

Higher-level
food
and
drug
administration
department
shall
be
responsible
for
directing
and
supervising
the
supervision
and
management
on
the
medical
device
operation conducted by lower-level food and drug administration department.
Article 4


Classified management shall be implemented for medical device operation
according to the risk level of medical device.
The operation of Class I medical devices may be exempted from licensing and filing;
filing management shall be implemented for the operation of Class II medical devices;
and licensing management shall be implemented for the operation of Class III medical
devices.

Article
5


China
Food
and
Drug
Administration
shall
formulate
the
good
supply
practice for medical devices and supervise the implementation.
Article
6

Food
and
drug
administration
department
should
timely
publish
the
information on the licensing and filing for medical device operation according to law.
Applicant may inquire about the progress and results of examination and approval and
the public may look up the examination and approval results.


Chapter II Operation Licensing and Filing Management
Article
7

Applicant
dealing
with
medical
device
operation
should
meet
the
following conditions:
(I)
Possess
the
quality
management
institution
or
quality
management
personnel
appropriate
to
the
operating
scale
and
business
scope;
the
quality
management
personnel
should
have
the
professional
educational
background
or
technical
title
in
relevant disciplines recognized by the state;
(II)
Possess
the
operating
and
storage
site
appropriate
to
the
operating
scale
and
business scope;
(III)
Possess
the
storage
conditions
appropriate
to
the
operating
scale
and
business
oom
may
not
be
set
up
in
case
of
the
storage
fully
entrusted
to
other
medical device operating enterprise;
(IV)
Possess
the
quality
management
system
appropriate
to
the
medical
devices
operated;
(V) Possess the capability of professional guidance, technical training and after-sales
service appropriate to the medical devices operated, or provide technical support by
relevant institution as agreed.
The
enterprises
dealing
with
the
operation
of
Class
III
medical
devices
should
also
have the computer information management system complying with the requirements
of the GSP for medical devices to ensure the traceability of the products operated. The
enterprises
dealing
with
the
operation
of
Class
I
and
Class
II
medical
devices
are
encouraged
to
establish
the
computer
information
management
system
complying
with the requirements of the GSP for medical devices.
Article 8

The operating enterprise dealing with the operation of Class III medical
devices should submit its application for the food and drug administration department
of the municipality with districts and submit the following materials:

(I) Copies of business license and organization code certificate;
(II) Copies of the ID cards, educational background or professional title certificates of
legal representative, responsible person of enterprise, and quality director;



(III) Explanation on the establishment of organizational structure and departments;
(IV) Explanation on business scope and business practice;

(V) Copies of the geological location map, floor plan and house ownership certificate
leasing agreement (attached with house ownership certificate);
(VI) List of operating facilities and equipment;
(VII)
List
of
documents
including
operating
quality
management
system,
working
procedure, etc.;

(VIII) Introduction of basic information of computer information management system
and explanations on functions;
(IX) Authorization certificate of agent;

(X) Other evidential materials.
Article 9

For the application for the licensing of the operation of Class III medical
devices submitted by applicant,
the food
and drug
administration department of the
municipality
with
districts
may
deal
with
respectively
according
to
the
following
situations:
(I)
If
the
item
applied
is
within
the
term
of
reference
of
the
department
and
the
application materials are complete and consistent with the legal form, the department
should accept the application;
(II) If the application materials are incomplete or not inconsistent with the legal form,
the applicant shall be informed of all contents to be added and/corrected in one time
either on site or within five (5) working days;
(III) If the application materials have any error that can be corrected on the spot, the
applicant should be allowed to make correction on the spot;
(IV) If the item applied is not falling into the term of reference of the department, the
department should immediately make the decision on denial to accept the application
and inform the applicant to submit application to relevant administrative department.
In case of acceptance or denial to accept the application for the licensing of medical
device
operation,
the
food
and
drug
administration
department
of
the
municipality
with districts should issue the Notice of Acceptance or Denial.
Article
10

The
food
and
drug
administration
department
of
the
municipality
with
districts should examine and verify the application materials within thirty (30)working
days from the date of acceptance and carry out on-site verification according to the
requirements of the Good Supply Practice for medical devices. In case of rectification
required,
the
rectification
time
will
not
be
included
in
the
examination
and
verification time.
For
those
meeting
specified
conditions,
the
written
decision
on
licensing
shall
be
made according to laws and the
License for Medical Device Operation
shall be issued
within ten (10) working days; for those not meeting specified conditions, if the written
decision on denial is made, the reasons should be specified.
Article 11


If the application for the licensing of medical device operation directly
relates to the major interest relationship between the applicant and others, food and
drug administration department should inform the applicant and the interested party of
the
rights
to
apply
for
hearing
enjoyable
according
to
laws
and
regulations
and
the
relevant
provision
of
China
Food
and
Drug
Administration;
while
conducting
examination
of
the
licensing
for
medical
device
operation,
food
and
drug
administration
department,
if
deems
the
application
as
the
major
licensing
item
relating to public interest, should announce to the public and hold a hearing.

Article 12

In case of the operation of Class II medical devices, operating enterprise
should
file
with
the
local
food
and
drug
administration
department
of
municipality
with districts, fill in the Class II Medical Device Operation Filing Form, and submit
the materials specified in Article 8 of these measures (except for Item 8).
Article 13

Food and drug administration department should verify the integrity of
the
materials
submitted by
enterprise
on
the
spot;
filing
will
be
permitted
for
those
complying
with
the
provisions
and
issued
with
the
certificate
of
filing
for
the
operation of Class II medical devices.
Article
14


The
food
and
drug
administration
department
of
the
municipality
with
districts
should
carry
out
the
on-the-spot
verification
on
the
operating
enterprise
of
Class II medical device according to the requirements of the Good Supply Practice for
medical devices within 3 months from the filing date of the medical device operating
enterprise.


Article 15

The valid period of the
License for Medical Device Operation
is five (5)
years,
which
shall
indicate
such
items
as
license
number,
name
of
enterprise,
legal
representative,
responsible
person
of
enterprise,
residence,
site
of
business
operation,mode
of
operation,
business
scope,
address
of
warehouse,
issuing
body,
issuing date, valid period, etc.




The certificate of filing for medical device operation should indicate such items as the
number,
name
of
enterprise,legal
representative,
responsible
person
of
enterprise,
residence, site of business
operation, mode of operation, business
scope, address
of
warehouse, filing department, filing date, etc.


Article
16


The
change
of
the
items
in
the
License
for
Medical
Device
Operation

may be classified into change of licensing item and change of registration item.
Change
of
licensing
items
includes
site
of
business
operation,
mode
of
operation,
business scope, and address of warehouse.
Change of registration items includes other items beyond aforesaid items.


Article
17

In case of
change of licensing items, the application for change of the
License
for
Medical
Device
Operation

shall
be
submitted
to
the
original
issuing

materials
relating
to
the
change
of
contents
as
specified
in
the
provisions of Article 8 of these measures should be submitted.




If
warehouse
is
arranged
across
administrative
regions,
applicant
should
handle
the
filing
with
the
food
and
drug
administration
department
of
the
municipality
with
districts where the warehouse is located.

The original issuing department should verify within fifteen (15) working days after
receiving the application for change and make decision on permission for change or
denial
for
change;
if
on-the-spot
verification
should
be
conducted
according
to
the
requirements
of
the
Good
Supply
Practice
for
medical
devices,
the
decision
on
permission for change or denial for change shall be made within thirty (30) days after
receiving
the
application
for
change.
In
case
of
denial
for
permission,
the
reasons
should be specified in written and the applicant should be informed. The number and
valid
period
of
the
changed
License
for
Medical
Device
Operation

shall
remain
unchanged.

Article 18


For new independent site of business operation, medical device operation
licensing or filing should be applied independently.

Article
19

In
case
of
change
of
registration
items,
medical
device
operating
enterprise
should
timely
handle
the
procedures
for
change
with
the
food
and
drug
administration department of the municipality with districts.


Article
20

The
medical
device
operating
enterprise
existed
due
to
splitting
and
merger
should
apply
for
change
of
licensing
according
to
the
provisions
of
these
measures;
the
medical
device
operating
enterprise
dissolved
due
to
splitting
and
merger
should
apply
for
cancellation
of
the
License
for
Medical
Device
Operation
;
and
the
medical
device
operating
enterprise
newly
established
due
to
splitting
and
merger should apply for handling the
License for Medical Device Operation
.


Article
21


Medical
device
registrant,filer
or
manufacturing
enterprise
selling
medical
devices
at
their
residences
or
manufacturing
site
may
not
handle
operation
licensing or filing; in case of storing at other places and selling medical devices on the
spot, they should handle the operation licensing or filing according to provisions.

Article
22

If
the
valid
period
of
the
License
for
Medical
Device
Operation

is
extended
upon
expiration,
medical
device
operating
enterprise
should
submit
the
application
for
the
extension
of
the
License
for
Medical
Device
Operation

with
the
original issuing department six months before the expiration of the valid period.
Original issuing department should verify the application for extension according to
the
provisions
in
Article
10
of
these
measures;
if
necessary,
conduct
on-the-spot
verification,
and
make
the
decision
on
whether
to
approve
the
extension
before
the
expiration
of
the
valid
period
of
the
License
for
Medical
Device
Operation
.
If
the
application for extension that meets the specified conditions is approved,the number
of the extended
License for Medical Device Operation
shall remain unchanged. Those
not complying with the specified conditions should be instructed to make rectification
within
specified
time;
if
the
specified
conditions
still
fail
to
meet
the
specified
conditions after rectification. The application for extension shall not be approved and
the reasons should be specified in written. If no decision is made overdue, it will be
regarded as the extension is approved.
Article 23


In case of any change to the filing items such as the name of enterprise,
legal
representative,
responsible
person
of
enterprise,
residence,site
of
business
operation, mode of operation, business scope, address of warehouse, etc. in the filing
certificate
of
medical
device
operation,
the
filing
should
be
changed
in
a
timely
manner.

Article 24

In case that the
License for
Medical Device Operation
is
lost, medical
device operating enterprise should immediately publish lost declaration on the media
designated
by
the
original
issuing
department.

After
1
month
after
the
lost
declaration
is
published,
the
application
for
re-issuance
of
the
certificate
shall
be
submitted to the original issuing department. The original issuing department should
timely re-issue the
License for Medical Device Operation
.
The number and valid period of the re-issued
License for Medical Device Operation

shall be the same as the original certificate.
Article
25

If
the
filing
certificate
for
medical
device
operation
is
lost,
medical
device operating enterprise should immediately handle the procedures for re-issuance
with the original filing department.

Article 26

If medical device operating enterprise is investigated by food and drug
administration department due to illegal business but the case has not been closed or
receives
the
decision
on
administrative
sanction,
the
food
and
drug
administration
department of the municipality with districts should terminate the licensing until the
case is completed.





Article 27


In case that the certificate of medical device operating enterprise should
be canceled according to the provisions of the laws and regulations or the valid period
of
the
license
has
not
expired
but
the
enterprise
proposes
the
cancellation
with
initiative,
the
food
and
drug
administration
department
of
the
municipality
with
districts
should
cancel
the
License for
Medical
Device Operation
according to
laws
and publish on website.




Article
28


The
food
and
drug
administration
department
of
the
municipality
with
districts should establish the licensing filing such as the issuance, extension, change,
re-issuance,revocation, cancellation, etc. of the
License for Medical Device Operation
and filing information file of medical device operation.


Article 29


Any unit and individual should not forge,alter,buy and sell,lease and lend
the
License for Medical Device Operation
and the filing certificate of medical device
operation.




Chapter III

Operation Quality Management
Article
30


Medical
device
operating

enterprise
should
establish
the
operation
management system covering the whole course of quality management according to
the requirements of the Good Supply Practice for medical devices and properly keep
the record, and ensure the operation conditions and operation behaviors to persistently
comply with the requirements.


Article 31


Medical device operating enterprise should bear the legal responsibility
for the medical device buying and selling behavior committed by the administrative
office or sales person in the name of the enterprise. The sales personnel of the medical
device
operating
enterprise
selling
medical
device
should
have
the
letter
of
authorization affixed with the official seal of the enterprise. The letter of authorization
should indicate the variety sold under authorization, region,and time limit and indicate
the ID card number of the sales person.


Article
32

Medical
device
operating
enterprise
should
establish
and
execute
the
incoming inspection and recording system. The operating enterprise dealing with the
wholesale business of Class II and Class III medical devices and the retail business of
Class
III
medical
devices
should
establish
sales
record
system.
The
information
of

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