Processing Authority: food and drug sub-administration at district/county
level
Processing Procedures:
(I) Business Starting Procedures
1 Any and
all of Classes II & III medical appliance operation enterprises shall, upon
business starting, apply to the competent local food and drug sub-administration
that governing the place where the enterprises run business operation and
present any and all of the following materials whereto:
(1) the Notice and
Letter of Commitment of Business Starting License of Medical Appliance Operation
Enterprise;
(2) the Notice of Pre-Approval of Business Name issued by the
competent industrial and commercial administration;
(3) the (xerox copy of
the) personal identity card of the legal representative of the very enterprise;
and
(4) other supporting documents necessary for such application.
2 The
competent food and drug sub-administration at district/county level shall,
within 5 working days upon receipt of the said Letter of Commitment and other
relevant materials presented by the very applicant, duly review them and issue
the Notice of Business Starting License of Medical Appliance Operation
Enterprise to the very applicant which shall, upon presenting such Notice, apply
to the competent industrial and commercial administration for the Business
License.
Any and all of enterprises whose applied business scope is "all
kinds of medical appliances" shall apply to the municipal food and drug
administration.
(II) Licensing Procedures
1 Any and all of enterprises
shall, upon completing incorporation preparation subject to the Interim Rules of
Shanghai Municipality for Business Start and License of Medical Appliance
Operation Enterprises, apply to the competent local food and drug
sub-administration that governs the place where the enterprises run operation
and present any and all of the following materials whereto:
(1) the
Application Form for License of Medical Appliance Operation Enterprise;
(2)
the (xerox copy of the) Business License (stamped with the official
seal);
(3) the (xerox copies of the) supporting documents of qualification
and training of key executive officers of the enterprises;
(4) the relevant
supporting documents of business(/storage) places: the (xerox copies of the)
muniment of title, or the muniment of title of the lessor and the lease
agreement;
(5) the self-check table of qualification verification conditions
for the medical appliance operation enterprise;
(6) the catalogue of the
business operation quality management system of the enterprises;
(7) the
letter of commitment for liability issued by the parent companies of the
enterprises that are one of branches whereof, if any; and
(8) other
supporting documents necessary for such application.
2 The competent food and
drug sub-administration at district/county level shall, within 15 working days
upon receipt of the materials necessary for such application, conduct the due
review of them and of the field, and issue the License of Medical Appliance
Operation Enterprise to the very applicant which is qualified for the said
conditions or inform the very applicant who failed in meeting the said
conditions of causes for not-approval in writing, if any.
Any and all of
enterprises whose applied business scope is "all kinds of medical appliances"
shall be subject to the joint review and approval by the municipal food and drug
administration and the competent local food and drug sub-administration which
governs the place where the enterprises run business operation, and to the
routine supervision and administration by that sub-administration.
(III)
Application for Alteration
1 Any and all of enterprises who intend to alter
the License of Medical Appliance Operation Enterprise in part or in whole shall
apply to the competent local food and drug sub-administration that governs the
place where the enterprises run business operation and present any and all of
the following materials whereto:
(1) the Application Form for Alteration of
Medical Appliance Operation Enterprise;
(2) the original and copy of the
License of Medical Appliance Operation Enterprise;
(3) the (xerox copy of
the) Business License;
(4) supporting documents related to such alteration
are as follows:
In case of alteration of the legal representative or the key
officer of the enterprise, the official document of approval by the enterprise's
governing authority and/or the resolution by the board of directors whereof, and
the (xerox copy of the) personal identity card and training certification of the
substitute legal representative or the key officer of the enterprise shall be
presented.
In case of alteration of the business name, the xerox copy of the
Notice of Pre-Approval of Business Name issued by the competent industrial and
commercial administration shall be presented.
In case of alteration of the
place of business operation, the house lease agreement and/or the muniment of
title shall be presented.
In case of alteration of the business scope, the
(xerox copies) of the supporting documents for qualification and training of the
key executive officers of the very enterprise, the self-check table of
qualification verification conditions for the medical appliance operation
enterprise, and the catalogue of the business operation quality management
system of the enterprise shall be presented.
(5) other supporting documents
necessary for such application
2 The competent food and drug
sub-administration at district/county level shall, within 5 working days upon
receipt of the materials necessary for application for alteration of the legal
representative, the key officer, or the business name of the very enterprise,
make the decision of approval or not, and shall, within 10 working days upon
receipt of the materials necessary for application for alteration of the place
of business operation or the business scope, conduct the due field review and
make the decision of approval or not.
Any and all of enterprises who apply
for alteration of the business scope into "all kinds of medical appliances"
shall be subject to the joint review and approval by the municipal food and drug
administration and the competent local food and drug sub-administration which
governs the place where the enterprises run business operation, and to the
routine supervision and administration by that sub-administration.
Charging
Standard & Basis: RMB 300 per License of Medical Appliance Operation
Enterprise
Processing Basis:
(I) Regulations of Supervision and
Administration of Medical Appliances under No. 276 Order of State
Council;
(II) Measures for Supervision and Administration of Medical
Appliance Operation Enterprises under No. 19 Order of State Food and Drug
Administration;
(III) the classified catalogue of products of China's medical
appliances;
(IV) Regulations of Shanghai Municipality on Supervision and
Administration of Disposable Aseptic Medical Appliances under No. 5 Order of
Shanghai Municipal People's Government;
(V) Measures for Supervision and
Administration of Disposable Aseptic Medical Appliances under No. 24 Order of
State Food and Drug Administration;
(VI) Detailed Rules for Implementation of
Qualification Approval of Enterprises Running Business Operation of Disposable
Aseptic Medical Appliances (for Trial Implementation) under Guo Yao Jian Shi
(2001) No. 444;
(VII) Interim Rules of Shanghai Municipality for Business
Start and License of Medical Appliance Operation Enterprises under Hu Yao Jian
(2002) No. 650;
(VIII) Rules of Shanghai Municipality for Application for
Alteration of Licenses of Medical Appliance Operation Enterprises under Hu Yao
Jian (2002) No. 883; and
(IX) Reply on Approval of Imposing Charges for
Review of Licenses of Medical Appliance Production/Operation Enterprises under
Hu Cai Zong (2000) No. 46 and Hu Jia Xing (2000) No. 158 jointly issued by
Shanghai Finance Bureau and Shanghai Pricing Bureau.
Processing Time:
Tuesdays or Thursdays: 9:00~11:00 and 13:00~16:00
Qualified Application
Subject: Any and all of applicants:
(I) that have the required places and
environment of business operation;
(II) that have the required quality
inspection personnel;
(III) that have the capacities of training, maintenance
and other after-sale services of products
(IV) that have established the
quality management system of medical appliances; and
(V) that have collected
and kept the national standards and the industrial standards related to medical
appliances. |
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