(1) The Advertising Law of the People's Republic of China;
(2) the state regulations on the management of medical devices;
(3) the state administrative laws and regulations on the management of advertisements and advertising supervision and management authorities to formulate standards for the review of advertisements. Article 4 The State Administration of Medicine and the provinces, autonomous regions and municipalities directly under the Central Administration of Medicine or the same level of supervision and management of medical devices (hereinafter referred to as the provincial supervision and management of medical devices), under the guidance of the advertising supervision and management authorities at the same level, the examination of medical device advertisements. Article 5 The advertisements of medical device products produced abroad, and the advertisements of medical devices released using key media (see catalog) shall be reviewed and approved by the State Administration of Medicine and filed with the provincial medical device administrative supervision and management department where the advertisements are released before they are released.
Other medical device advertisements shall be reviewed and approved by the provincial medical device administrative supervision and management department where the manufacturer is located, and filed with the provincial medical device administrative supervision and management department where the advertisements are published before they are released. Article VI Application for Medical Device Advertising:
(1) Application for review of the domestic production of medical device product advertising, should fill out the "Medical Device Advertising Review Form", and submit the following documents:
1. A copy of the applicant's and the producer's business license, as well as other production and business qualifications of the documents;
2. Certificate of registration of the manufacture of the product or product approval, the implementation of the production license management of the product, but also to the provincial medical device administrative supervision and management department for record. Implementation of the production license management of products, production license should also be provided;
3. Product instructions;
4. Laws and regulations and other documents to confirm the authenticity of advertising content.
(B) apply for review of overseas production of medical equipment product advertising, should fill out the "Medical Device Advertising Review Form", and submit the following documents and corresponding Chinese translations:
1. applicant and producer of business license copies and other production, business qualifications of the documents;
2. medical device manufacturer in the country (region) where the government The government of the country (region) where the medical device manufacturer is located approves the product to enter the market;
3. product standards;
4. product instruction manuals;
5. Chinese laws and regulations and other documents to confirm the authenticity of the advertisement content.
Provide a copy of the documents specified in this article, the original certification authority shall be signed or issued by the country (region) notary public notarized documents. Article VII application for advertising review can be entrusted to the distributor of medical devices or advertising operators on behalf of the process. Article VIII review of medical device advertisements:
(1) preliminary examination
The medical device advertising review authority on the advertisement applicant to provide the authenticity, validity, legality, completeness of the supporting documents and the authenticity of the advertisement before the production of the manuscript, the legitimacy of the review, and acceptance of the application within five days from the date of the preliminary examination of a decision to be made, issued the "preliminary examination of the decision notification".
(2) Final Review
The applicant of the advertisement shall send the decision of passing the preliminary review and the advertisement work to the original advertisement reviewing authority again, and the advertisement reviewing authority shall make a decision of final reviewing within five days from the date of acceptance of the application, and issue the "Review Form of Advertisement of Medical Devices" and the advertisement reviewing and approving number for those who have passed the final review; for those who have failed in the final review, they shall notify the applicant of the advertisement and state the reasons.
(C) the applicant may apply directly for final examination, the advertising review authority within ten days from the date of acceptance of the application to make a final decision.
(4) If the reviewing authority in the place where the advertisement is published still disagrees with the reviewing decision made by the reviewing authority in the place where the producer is located, it shall submit it to the higher advertising reviewing authority for a ruling. The review opinion shall be subject to the conclusion of the ruling. Article 9 The "Notice of Decision on Preliminary Examination" issued by the medical device advertisement examination authority and the "Medical Device Advertisement Examination Form" with the advertisement examination and approval number shall be signed by the person in charge of the advertisement examination organization and stamped with the special seal for examination of medical device advertisements.
The medical device advertisement reviewing authority shall send the "Medical Device Advertisement Review Form" with the advertisement review and approval number to the advertising supervision and management authorities at the same level for inspection. Article 10 of the medical device advertising review approval number is valid for one year, of which the product introduction and sample review approval number of the validity can be extended to three years. Article 11 The examination and approval of medical device advertisements, one of the following circumstances, the advertising review authority shall call back for review.
(a) changes in the basis of advertising review;
(b) the State Administration of Medicine that the approval of the provincial advertising review authority is not appropriate;
(c) advertising supervision and management authorities or the release of the medical device advertising review authority to put forward the review proposal;
(d) advertising review authority that should be transferred back to the review of other cases.
During the period of review, the advertisement stops being published. Article XII of the examination and approval of medical device advertising, one of the following circumstances, shall reapply for review:
(A) the expiration of the validity of the approval number of the examination of medical device advertisements;
(B) the content of the advertisements need to be altered;
(C) changes in the product standards for medical devices.