Application for Medical Appliances Advertisements in Shanghai

[2008-12-23 16:54:10]

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).

Source: 上海市人民政府

Keywords:Quality Supervision

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