Application formalities: (I) A written application on advertising of medical instruments of Shanghai
(II) Form of examination on medical instrument advertising
2. Manufacturers of medical instrument in Shanghai: five original scripts and a set of electronic texts of advertisement (the text is made with soft ware of examination application for drug advertisement from the State Food and Drug Administration(SFDA) and is to be downloaded from www.sda.gov.cn to be installed).
To be put on record: one original script and four copies.

(III) Duplicate of business license of the advertisement owner (copies stamped with official seals);
(IV) Duplicate of applicant's business license(copies stamped with official seals);
(V) Registration certificate on medical instruments, attached with a form of authorizing manufacturing medical instruments (copies stamped with official seals of the manufacturer), and specifications of authorized product;
(VI) Valid original of letter of attorney;
(VII) Copies of ID card of the person handling the affair;
(VIII) Supporting documents prescribed by the laws and regulations to confirm trueness of the advertisement contents;
(IX) Script for advertisement:
1. Script for advertisement put on newspapers (five copies for one script);
2. Script for television advertisement (five copies for a script, two sets of video tape or vcd or dvd);
3. Script for advertisement put on radio program (five copies for a script, two recording tapes).
Transaction procedures:
According to news on August 3rd from shanghai: (I) manufacturers of medical instruments in Shanghai to release advertisements on medical instruments should file in an application to Shanghai Food and Drug Administrative Bureau before releasing advertisements, submitting relevant materials. Those getting approval are to be issued a "Registered Number of Approval on Medical Instrument Advertising"; those not getting the approval are to be notified in written form and informed of the reasons. Applicants getting registered number of approval on medical instrument advertising can release their advertisements; those not getting the approval must not release their advertisements. 
If manufacturers of medical instruments are to release their advertisements by means of key media, they should be examined and get approval from the SFDA and put their application on record at drug administrative bureau on provincial level of the place where they are to put their advertisements before releasing their advertisements.
(II) If agents for imported medical instruments or those manufacturers from other places are to release their advertisements in shanghai, they should get "Registered Number of Approval on Medical Instrument Advertising" issued by SFDA or their local (food) and drug administrative bureaus, and then apply to Shanghai Food and Drug Administrative Bureau to be put on record. Those not having their application put on record must not release advertisements for their medical instrument products. 

Examination and approval on medical instrument advertising:
(I) Examination:
Shanghai Food and Drug Administrative Bureau is to do examination work on advertisement contents and relevant documents within 10 working days from the day when they receive complete application materials.
If materials are to be complemented, applicants should be notified with "Notice on Examination Opinion by Shanghai Food and Drug Administrative Bureau" on the spot or within 5 days. Applicants should make correction within prescribed time limit, and time limit for examination during correction work is not included in the time for examination work. Those proved to be qualified in the examination are to be issued a "Notice on Examination Opinion of Application Materials", and applicant enterprises should make their advertisements according to contents verified in the examination work. 

(II) Examination and approval
With the "Notice on Examination Opinion of Application Materials", applicant enterprises send their finished advertisement to department for advertisement examination. For those proved to be qualified, Shanghai Food and Drug Administrative Bureau is to stamp seals for special use of examination on medical instrument advertising and issue "Form of Examination on Medical Instrument Advertising" with registered number of approval on advertising examination.
Charging standard and its basis:
Submit to:
Address: No.1399 Huashan Road, Shanghai (Qualifications Authorization Center on Medicine Trade of Shanghai)

Audituser:
The transaction is based on: (I) "Law on Advertisements of People's Republic of China"
(II) "Regulations on Supervision and Management of Medical Instruments" Decree No.276 from the State Council
(III) "Examination Methods on Medical Instruments Advertising" Decree No.24 from the previous State Medicine Administration and State Administration on Industry and Commerce
(IV) Norms on Examination of Medical Instrument Advertising", Decree No.23 from State Administration on Industry and Commerce"

Tel.: 021-62837766, 62830955
Website:
Time for transaction: Mondays and Wednesdays: 9:00-11:30, 13:00-16:00
Fridays: 9:00-11:30
Time limit for transaction:
Applicant qualifications:
(I) Medical instrument manufacturers of Shanghai apply to release advertisements on medical instruments;
(II) For advertisements on medical instruments from other places outside Shanghai approved by SFDA or by organs for examination on medical instruments at other provinces or municipalities, the applicants apply to release their advertisements in Shanghai (to be put on record).