(Approved by the State Administration for Industry and Commerce and the State Pharmaceutical Administration, the Measures on Examination and Approval of Medical Appliance Advertisements are promulgated and take effect on March 8, 1995)
Article 1
The present measures are formulated in accordance with the Advertisement Law of the People's Republic of China.
Article 2
The measures apply to the examination and approval of any advertisements, including product introduction and samples, of instruments, facilities, appliances, equipment, implant, and other materials used for the diagnosis, treatment, prevention of human diseases and adjustment of human body's physical function, or for the transplant of body organs.
Article 3
The examination and approval of medical appliance advertisements are based on the following laws and regulations:
1) The Advertising Law of the People's Republic of China.
2) The State's relevant regulations governing medical appliances.
3) The State's relevant regulations governing advertising administration and standards stipulated by the advertising supervision departments.
Article 4
The State Pharmaceutical Administration and medical administrations at the provincial, (autonomous) regional, and municipal levels or medical appliance supervision departments at the same levels (hereinafter referred to as provincial-level medical appliance supervision departments) should examine and approve medical appliance advertisements under the guidance of advertisement supervision departments at the same level.
Article 5
Advertisements of overseas-produced medical appliances and advertisements to be published by such key mass media (as shown in separate list) can only be released after having been examined and approved by the State Medical Administration and reported to and registered with the provincial-level medical appliance supervision department located at the place where such advertisement is to be published.
Other medical appliance advertisements should be examined and approved by the provincial-level medical appliance supervision department at the place of production and reported to and registered with the said department at the place where such advertisement is to be published.
Article 6
The application of medical appliance shall be made in the following order:
1 ) For advertisements of domestically-produced medical appliances, the applicant should fill out the Examination Form of Advertisements of Medical Appliances and submit it along with the following materials:
a) The duplicate copy of the business license of the applicant and the manufacturer and other relevant documents certifying the production and marketing of the medical appliance in question;
b) The product's registration or approval certificate and also the product license, in case such product is produced under a production license;
c) The operation manual of the product;
d) Other documents required by laws and regulations and additional materials needed in proving the authenticity of the contents of advertisement.
2) For advertisements of overseas-produced medical appliances, the applicant should fill out the Examination Form of Advertisements of Medical Appliances, and submit it along with the following document as well as their Chinese translations.
a) The duplicate copy of the business license of the applicant and the manufacturer and other relevant documents certifying the production and marketing of the medical appliance in question;
b) Certificates, which certify the marketing of the product, as issued by the government of the country or region where the manufacturer is located;
c) The relevant standard of the product;
d) The operation manual of the product;
f) Other documents required by Chinese laws and regulations and additional materials needed in proving the authenticity of the contents of the advertisement.
All duplicates of the required certificates should be signed by the issuing organs or be accompanied by notarial documents issued by the notary public of the original country or region.
Article 7
An applicant can entrust its medical appliance marketing agent or advertising agent to file its application for examination and approval of the advertisement of its product.
Article 8
The examination and approval of the medical appliance advertisement shall be conducted in the following order:
1 ) For preliminary examination:
The departments in charge of the examination of medical appliance advertisement shall check the authenticity, validity, legality, and integrity of the certifying documents as submitted by the applicant, and examine the authenticity and legality of the advertisement's manuscript. It shall make decision on the preliminary examination within five days after accepting the application and issue the Notice of Decision on the Preliminary Examination to the applicant.
2) For final examination:
Having passed the preliminary examination, an applicant should submit the decision notice together with the advertising design to the original advertisement examination department. The department shall then make a decision on final examination within five days after accepting the application. For those which have passed the final examination, the department should issue the Examination Form of Advertisement of Medical Appliances and the approval certificate number of the examination. For those which have failed to pass the final examination, it shall explain to the applicants in question on the reason of their failure in the examination.
3) An applicant can directly apply for the final examination, and the advertisement examination department shall make a decision on the final examination, within 10 days after accepting the application.
4) The local examination department of the place, where the advertisement is to be published, shall apply to the advertisement examination department of a higher level for arbitration, if it objects to a final examination decision made by the examination department of the place where the advertised item is produced. The final decision on examination shall be based on the result of such arbitration.
Article 9
The Notice of Decision of the Preliminary Examination and Examination Form of Advertisements of Medical Appliances with approval certificate number issued by the medical appliance advertisement examination departments should be signed by a responsible person of the advertisement examination departments and be stamped with a special seal for the examination of medical appliance advertisement.
An examination department shall submit the Examination Form of Advertisements of Medical Appliances with the approval certificate number to the advertisement supervision department of the same level.
Article 10
The effective term of an approval certificate number for medical appliance advertisement is one year, and the effective term for approval of product introduction and sample examination can be extended to three years.
Article 11
If an approved advertisement of medical appliance is involved in any of the following cases, the examination department should revoke its original approval and recall the advertisement for re-examination.
1) Changes in the conditions, on which the original examination was based;
2) The State Medical Administration regards such an approval by a provincial-level examination department as inappropriate.
3) The advertisement supervision department or medical appliance advertisement examination department of the place, where the product is marketed, have suggested a re-examination of the advertisement.
4) Other situations which make the advertisement supervision department regard the advertisement as in need of re-examination.
Article 12
In any of the following case, the owner of an already-approved advertisement should apply for re-examination:
1) The term of the approval certificate number has expired.
2) The contents of the advertisement needs a revision.
3) The standard of the product has changed.
Article 13
An examination department should revoke the Examination Form of Advertisement of Medical Appliances and cancel the approval certificate number of an approved advertisement, if it is involved in any of the following circumstances:
1) The registration or approval number of the product is canceled because of problems found in the performance of the medical appliances.
2) The medical appliance has been listed as obsolete by the State.
3) The advertisement has failed to pass the re-examination.
4) The applicant should reapply for examination but has failed to do so, or it has failed to pass a re-examination.
Article 14
An advertisement examination department should submit the decision on revoking an approval certificate number to the advertisement supervision department of the same level for reference.
Article 15
The approval certificate number should be listed as part of the contents of the advertisement and published after the advertisement has passed the examination. Advertisers should not publish any advertisement that is not marked with an approval certificate number, or any advertisement whose approval certificate number is outdated or any advertisement whose approval certificate number has already been canceled.
Article 16
Before running an advertisement, an advertiser should first check the original copy of Examination Form of Advertisements of Medical Appliances or its duplicate as stamped by its original examination department and keep the document for one year.
Article 17
Advertisers who violate these measures will be punished according to Article 43 of the Advertisements Law of the People's Republic of China.
Article 18
In case, an advertisement examination department, which has approved and led to the publication of an illegal advertisement that violated basic conditions required for such approval, the State advertisement supervision departments should report it to the State Medical Administration. And it will be punished according to Article 45 of the Advertisements Law.
Article 19
These measures come into effect as of March 8, 1995.
