Processing Authority: Circulation Management Office
under Shanghai Food and Drug Administration
Application Formalities:
(I)
the letter of application for the very medical appliance advertisement;
(II)
the review form of medical appliance advertisement
1. medical appliances
production enterprises in Shanghai: the original in quintuplicate with one set
of the electrical-version of the advertisement (which shall be produced via
using the advertisement review application software of State Food and Drug
Administration which can be installed upon download from www.sda.gov.cn);
2. Record Filing: one
original and xerox copies in quadruplicate
(III) the copy of business license
of the very advertiser (the xerox copy stamped with the official seal);
(IV)
the copy of business license of the very applicant (the xerox copy stamped with
the official seal);
(V) the certificate of registration of medical appliance
products attached with the recognition form of production/manufacture of medical
appliance products (the xerox copy stamped with the official seal), and the
approved product instrument;
(VI) the original of the valid letter of
authorization;
(VII) the xerox copy of the personal identity card of person
who deals with such application;
(VIII) the supporting documents provided by
laws and regulations and confirming the trueness of contents of the very
advertisement; and
(IX) publication script of the very advertisement:
1.
the publication script of press plane advertisement in quintuplicate;
2. the
publication script of TV advertisement in quintuplicate, and two sets of VCR
tapes, VCDs or DVDs; and
3. the publication script of radio advertisement in
quintuplicate, and two magnetic tapes.
Processing Procedures:
(I) Any and
all of medical appliance production enterprises intending to launch medical
appliance advertisements shall, prior to such launch, apply to Shanghai Food and
Drug Administration and present any and all of required materials, and shall not
launch until obtaining the Registered Number of Approval for medical appliance
advertisement wherefrom. Shanghai Food and Drug Administration will, in case of
approval, issue the Registered Number of Approval for Medical Appliance
Advertisement, or, in case of not approval, inform the very applicant in writing
with causes.
Medical appliance advertisement shall not be launched on the key
media unless approval by State Food and Drug Administration after due review is
obtained and record is filed in the competent food and drug administration at
the provincial level which governs the place where the advertisement is
launched.
(II) Any and all of imported medical appliances or medical
appliances produced in other provinces, autonomous regions or municipalities in
China intending to launch medical appliance advertisements shall, prior to such
launch, obtain the Registered Number of Approval from State Food and Drug
Administration or the competent local food and drug administrations which govern
the place where they are located at first, and then apply to Shanghai Food and
Drug Administration for record filing and present any and all of required
materials, and shall not launch until completing any and all of formalities
necessary for such record filing.
Review of Advertisement:
(I) First
Review
Shanghai Food and Drug Administration shall, within 10 working days
upon receipt of the complete set of materials necessary for such application,
conduct the due review of the content of the very medical appliance
advertisement and the relevant supporting documents.
In case materials need
revised or supplemented according to the result of such review, Shanghai Food
and Drug Administration shall, then and there or within 5 days, issue the Notice
of Opinion of Materials Review by Shanghai Food and Drug Administration to
inform the very applicant of such revision or supplementation. The very
applicant shall complete revision or supplementation within the provided time
frame where the time frame for review shall be suspended. In case materials pass
review, Shanghai Food and Drug Administration shall issue the Notice of Opinion
of Materials to the very applicant who shall produce the finished advertisement
product subject to the approved contents in and requirements by the first
review.
(II) Final Review
The very applicant shall, upon the Notice of
Opinion of Materials issued by Shanghai Food and Drug Administration, present
the finished advertisement product to the competent advertisement review
department under Shanghai Food and Drug Administration which shall, in case of
approval, issue the Form of Review of Medical Appliance Advertisement stamped
with the special seal for review of medical appliance advertisement and bearing
the registered number of approval for review of the very advertisement.
(III)
Any and all of applicants are entitled to apply for the final review
directly.
Processing Address: (Shanghai Certification Center of Qualification
of Medical Industry) No. 1399, Huashan Road, Shanghai
Processing Basis:
Advertisement Law of the People's Republic of China;
Regulations of
Supervision and Administration of Medical Appliances under No. 276 Order of
State Council;
Measures for Review of Medical Appliances Advertisements under
No. 24 Order jointly issued by former State Drug Administration and State
Administration for Industry and Commerce of the People's Republic of China;
and
Standard for Review of Medical Appliances Advertisements under No. 23
Order issued by State Administration for Industry and Commerce of the People's
Republic of China
Contact Tel: 021-62837766¡¢62830955
Processing Time:
Mondays or Wednesdays: 9:00~11:30 and 13:00~16:00
Fridays: 9:00~11:30
Time
Limit for Processing:
Qualified Application Subject: Scope of
Application:
(I) Any and all of medical appliance production enterprises in
Shanghai applying for launching medical appliance advertisements.
(II) Any
and all of advertisements approved by State Food and Drug Administration or
medical appliances review authority in other provinces, autonomous regions or
municipalities in China applying for launching medical appliance advertisements
in Shanghai (record filing). |
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