Processing Authority: Safety Control Office under Shanghai Food and Drug
Administration
Processing Procedures:
1. Application for Business
Start
(1) Any and all of applicants shall represent the application in
writing covering any and all of contents as follows:
a. the Application Form
for Medical Appliance Production Enterprise in Shanghai;
b. the (xerox copy
of the) Notice of Pre-Approval of Business Name issued by the competent
industrial and commercial administration;
c. the (originals which will be
returned upon review and xerox copies of the) supporting documents for personal
identities of the legal representative, partners or investors of the proposed
enterprise;
d. the (original which will be returned upon review and xerox
copy of the) supporting document of production site (muniment of title or the
agreement of lease intent);
e. the (original which will be returned upon
review and xerox copy of the) relevant contract or agreement of investment
cooperation, and articles of association whereof, if necessary.
(2) Shanghai
Food and Drug Administration shall, within 15 working days upon receipt of the
complete materials necessary for such application, conduct the due review of
them, determine the business type of the very enterprise, make the decision of
approving the business start whereof or not, and, in case of approval, issue the
Notice of Approving Business Start of Medical Appliance Production Enterprise,
or, in case of not-approval, inform the very applicant in writing with causes.
The very applicant shall not apply to the competent industrial and commercial
administration for business license unless obtains the Notice of Approving
Business Start of Medical Appliance Production Enterprise.
2. Application for
License of Medical Appliance Production Enterprise
1) Any and all of
applicants shall, upon obtaining the business license issued by the competent
industrial and commercial administration and completing incorporation
preparation of the proposed enterprise, apply to Shanghai Food and Drug
Administration for the License of Medical Appliance Production Enterprise or
Form for Record Filing of Medical Appliance Production Enterprise, and present
any and all of materials as follows (one for each):
a. the Application Form
for License (Record Filing) of Medical Appliance Production Enterprise in
Shanghai;
b. the (xerox copy stamped with the official seal of the very
enterprise of the) Business License issued by the competent industrial and
commercial administration;
c. the (xerox copy of the) Notice of Approving
Business Start of Medical Appliance Production Enterprise,
d. the (original
which will be returned upon review and xerox copy of the) supporting document of
production site [muniment of title or the agreement of lease intent (muniment of
title of the lessor presented by the lessee, if any)];
e. the standard for
registered products of Class I/II products reviewed by Shanghai Food and Drug
Administration or of Class III products upon first review;
f. the (xerox
copies of the) supporting documents for qualifications and trainings of the
relevant personnel;
g. the running experimental verification summary and test
record of production/checkout equipments (the statutory supporting documents
shall be presented in case of products with special requirements);
h. the
(xerox copy of the) checkout report of production environment of aseptic medical
appliance products, if applicable; and
i. the quality assurance system file
or the list of quality management system directory.
2) Shanghai Food and Drug
Administration shall, within 30 working days upon receipt of application for
license/record filing by the very medical appliance operation enterprises,
review them subject to the applicable provisions, conduct the field survey to
lead two kinds of outcomes of field survey: "passing field review" in case of
Class A or B in the overall score, or "not passing field review" in case of
Class C in the overall score, issue the License of Medical Appliance Production
Enterprise to Class II/III medical appliance operation enterprise that pas
passed the materials review and field review, or the Form of Record Filing of
Medical Appliance Production Enterprise to Class I medical appliance operation
enterprise, and issue the notice of review termination with causes to the
enterprise whose production conditions fail to meet the provided
conditions.
3. Application for Change of License
(1) The medical appliance
operation enterprises may, upon completion of product registration, apply to
Shanghai Food and Drug Administration for changing the License of Medical
Appliance Production Enterprise valid only for application for product
registration into the License of Medical Appliance Production Enterprise with
the normal valid term, and resent any and all of materials as follows (one for
each):
a. the Application Form for Changing License of Medical Appliance
Production Enterprise in Shanghai;
b. the (xerox copy of the) the relevant
supporting documents for changing license and the certificate of product
registration;
c. the original and copy of the License of Medical Appliance
Production Enterprise;
(2) Shanghai Food and Drug Administration shall,
within 20 working days upon receipt of the complete materials necessary for
changing license, conduct the due review of them and make the decision of
approving to change license by issuing the License of Medical Appliance
Production Enterprise with normal valid period to the very applicant, or not
approving to change license by inform the very applicant in writing with
causes.
Charging Standard and Basis: 1. RMB 600 per License of Medical
Appliance Production Enterprise (producing Class II/III products).
2. RMB 300
per Form of Record Filing of Medical Appliance Production Enterprise (producing
Class I products)
Processing Address: Shanghai Drug and Medical Appliance
Review and Assessment Center, No. 1399, Huashan Road, Shanghai
Processing
Basis:
1. Articles XIX and XX of Regulations on Supervision and
Administration of Medical Appliances under No. 276 Order of State Council;
2. Measures for Supervision and Administration of Medical Appliance
Production Enterprises under No. 18 Order of State Food and Drug
Administration;
3. Notice on Printing and Forwarding Detailed Rules for
Implementation of License and Record Filing of Medical Appliance Production
Enterprises in Shanghai under Hu Yao Jian (2002) No. 349 issued by Shanghai Food
and Drug Administration; and
4. 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.
Contact Tel:
021-62837766- 811¡¢812¡¢813
Processing Time: Mondays through Thursdays:
9:00~11:30 and 13:00~16:30
Fridays: 9:00~11:30
Time Limit for Processing:
Qualified Application Subject: Scope of Application:
Any and all of Class
I medical appliance production enterprises intending to start businesses in
Shanghai apply for the Forms of Record Filing of Medical Appliance Production
Enterprise; and Any and all of Class II/III medical appliance production
enterprises intending to start businesses in Shanghai apply for the Licenses of
Medical Appliance Production Enterprise.
Qualifications/Prerequisites for
Applicant:
(1) There are professional technical personnel corresponding to
the medical appliances produced whereby;
(2) There are production/storage
place and environment corresponding to the medical appliances produced
whereby;
(3) There are production equipments corresponding to the medical
appliances produced whereby;
(4) There are inspection institutions or
personnel, and inspection equipments for inspection of medical appliances
produced whereby; and
(5) There are production quality assurance system or
quality management system. |
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