Processing Authority: food and drug sub-administration at district/county
level
Processing Procedures:
(I) Any and all of enterprises intending to
start business operation of Class I medical appliances shall apply for record to
the competent local food and drug sub-administration which governs the place
where the enterprises run business operation, and fill in and present the
required Letter of Commitment and relevant materials as follows:
1 the Letter
of Commitment of Information of Record 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 the (xerox copies of the) supporting documents of training of key
executive officers of the enterprises (stamped with the official seal);
5 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;
6 the self-check table of qualification verification conditions
for the medical appliance operation enterprise
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.
(II) Any and all of enterprises intending to start business
operation of household common medical appliances shall apply for record to the
competent local food and drug sub-administration which governs the place where
the enterprises run business operation, and fill in and present the required
Letter of Commitment and relevant materials as follows:
1 the Letter of
Commitment of Information of Record of Medical Appliance Operation
Enterprise;
2 the Business License or the Notice of Pre-Approval of Business
Name (stamped with the official seal);
3 the (xerox copy of the) personal
identity card of the legal representative of the very enterprise;
4 the
(xerox copies of the) supporting documents of training of key executive officers
of the enterprises (stamped with the official seal);
5 the (xerox copies of
the) supporting documents of training of counter sales personnel (stamped with
the official seal);
6 the location drawing of medical appliances
counters/shelves in the emporium (stamped with the official seal); and
7
other supporting documents necessary for such application.
(III) Any and all
of enterprises intending to concurrently sell contraceptive devices or tools as
their shall apply for record to the competent local food and drug
sub-administration which governs the place where the enterprises run business
operation, and fill in and present the required Letter of Commitment.
(IV)
Any and all of chain supermarkets or convenient stores intending to concurrently
sell the Class I household common medical appliances or contraceptive devices or
tools shall apply for record to the competent local food and drug
sub-administration which governs the place where the enterprises run business
operation, and fill in and present the required Letter of
Commitment.
Procedures of Record:
The competent local food and drug
sub-administration at district/county level shall, within 5 working days upon
receipt of the required Letter of Commitment and other materials presented by
the applicants, review and issue the Notice of Record of Household Common
Medical Appliance Retail Operation Enterprise in Shanghai, upon which the very
applicants may apply to the competent industrial and commercial administration
for addition of "medical appliances" into their business scopes.
Charging
Standard & Basis: free of charges for any record subject to commitment of
information.
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) Interim Rules of Shanghai Municipality for Business Start
and License of Medical Appliance Operation Enterprises under Hu Yao Jian (2002)
No. 650;
(V) Rules of Shanghai Municipality for Record of Regular Commercial
Enterprises Starting Businesses of Retail Operation of Household Common Medical
Appliances (for Trial Implementation) under Hu Yao Jian Liu Tong (2002) No.
402;
(VI) Notice of Implementation of Commitment of Information and Record
Management of Retailing Contraceptive Devices and Tools in Shanghai under Hu Yao
Jian Liu Tong (2003) No. 157;
(VII) Notice of Supplementary Regulations on
Commitment of Information and Record Management of Household Common Medical
Appliances Concurrently Sold by Chain Supermarkets and Convenient Stores in
Shanghai under Hu Yao Jian Liu Tong (2004) No. 001; and
(VIII) other applied
regulations, rules, and normative documents.
Processing Time: Tuesdays or
Thursdays: 9:00~11:00 and 13:00~16:00
Qualified Application Subject:
Scope
of Application:
Application for record of enterprises intending to start
business operation of Class I and/or household common medical appliances and to
concurrently sell contraceptive devices and tools.
Prerequisites for Starting
Business:
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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