For some medical device manufacturers or operating companies, in order to achieve better promotion purposes and allow the public to accept, recognize and choose their products, they need to publish advertisements in relevant media. Chinese law stipulates that if a medical device that has obtained a CFDA registration certificate intends to publish its product name, product scope of application, performance structure and composition, mechanism of action, etc. through media means, it must apply for an advertising approval document from the local provincial medical device authority. No. before it can be officially released to the public. If you have obtained the medical device advertising license approval number and need to publish the advertisement in the media of other provinces, you must also register it with the drug regulatory department of other provinces. Otherwise, it is an illegal act and you will be held legally responsible.
Application material requirements:
1. Two copies of the "Medical Device Advertising Review Form" (copy) approved by the place of original review;
2. Original copy of the advertiser's legal person power of attorney (one copy);
3. If an agent applies for registration of medical device advertising on his or her behalf, the applicant's original power of attorney and a copy of the agent's business license and other subject qualification documents must be submitted. ;
4. Samples (samples, sample tapes) (one copy) that are consistent with the published content (such as CD, DVD or other general storage media);
5. A copy of the business license of the advertiser (manufacturing enterprise) and the applicant (applicant) and a copy (one copy) of other valid certification documents for production and business qualifications;
6. Medical device product registration certificate (including A copy (one copy) of the "Medical Device Registration Form";
7. When applying for the approval number for imported medical device advertising, the agent listed in the "Medical Device Registration Form" should be provided Or a copy of the subject qualification certificate of the organization established in China by an overseas medical device manufacturer;
8. A copy of the product instructions for use and the approved copy of the instructions for use approved by the food and drug supervision and administration department at or above the provincial level ( One copy) (if any);
9. Copies of other certification documents required by laws and regulations to determine the authenticity of the advertising content (copies of certification documents for overseas products must be signed by the original issuing authority) or a notarized document issued by a notary institution in the country (region) where the country (region) is located) (one copy);
10. Advertising commitment letter issued by the advertiser (production enterprise) (one copy);
11. A copy of the handler’s ID card (one copy);
12. If the advertisement involves registered trademarks, patents, certifications, etc. of medical devices, copies of relevant valid certification documents and Other supporting documents confirming the authenticity of the advertising content;
If the above materials are in foreign languages, corresponding Chinese translations should also be submitted; copies must be stamped with the official seal of the unit to which the certificate belongs for confirmation.