Do the products you sell violate advertising laws and relevant laws and regulations in the pharmaceutical industry?

      Consumers are easily deceived and misled by false publicity, especially that in the medical field, which will cause irreparable losses to patients. The “Advertising Law of the People’s Republic of China” clearly states that when publishing medical advertisements, the advertisement content shall be reviewed by the advertising review authority (the administrative department of health and family planning) before publication. Any advertisements shall not be published without review.

      China’s increasingly strict regulation of the pharmaceutical industry has also tightened regulations on the terms and materials used to promote products. We can assist you in checking the content and wording of the company’s product advertisements, promotional materials, websites, etc. If you knowingly display it as an advertisement, you will be fined and your corporate image will be affected. You need to abandon the mindset of “other companies are doing it too” or “we’ll pretend we don’t know and correct it when it’s pointed out” and instead focus on how to brand your product. Because once you are punished or exposed by relevant departments due to lax publicity, it will not only cause the company’s sales loss, but also affect the company’s brand value.

All Medical Device Advertisements Need to Apply for Advertising Registration

      According to Article 2 of the “Interim Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Foods for Special Medical Purposes”, advertisements for drugs, medical devices, health foods, and foods for special medical purposes shall not be published without review. As long as it is a medical device product, its advertisements need to be registered.

      Relevant departments that receive registration include: Market supervision and administration departments and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central government.

      Regarding the requirements for the content of advertisements, the requirements of the “Interim Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Foods for Special Medical Purposes” shall prevail. For example, the Article 6 stipulates that content of medical device advertisements shall be based on the registration certificate or filing certificate approved by the drug regulatory department, and the content of the registered or filed product instructions. Medical device advertisements involving the name, application scope, working mechanism or structure and composition of a medical device shall not exceed the scope of the registration certificate or filing certificate, or the registered or filed product instructions.

Q&A About Medical Device Advertising Management

Q1: Is it considered advertising if a medical institution publishes an introduction and outpatient arrangements after setting up its website?

A1: According to “Reply of the Former Ministry of Health on not Being Included in the Scope of Examination of Medical Advertisements for the Posting of Outpatient Medical Records on Medical Institution Profiles” (No. 127 of the Health and Medical Letter 〔2008〕), contents such as the institution introduction, specialty characteristics, disease prevention and treatment knowledge, and expert outpatient arrangements published by medical institutions in outpatient medical records, internal journals, or websites opened by the institution are temporarily not included in the scope of medical advertising review. The information provided by medical institutions through the above methods should be true and accurate. It is strictly prohibited to deceive and mislead patients with false information.

Q2: Can medical institutions publish advertisements arbitrarily after obtaining the “Medical Advertising Examination Certificate”?

A2: According to Article 11 of the “Advertising Law of the People’s Republic of China”, if the matters involved in the advertising content require administrative licensing, they must be consistent with the content of the license. Article 13 of the “Measures for the Administration of Medical Advertisements” stipulates that the “Medical Advertisement Examination Certificate” is valid for one year. If you still need to continue publishing medical advertisements after the expiration date, you should reapply for review. According to Article 17 of the “Measures for the Administration of Medical Advertising”, medical institutions shall publish medical advertisements in accordance with the content of finished advertising samples and media categories approved by the “Medical Advertising Review Certificate”. If the content of a medical advertisement needs to be modified or the practice of the medical institution changes, and it is inconsistent with the content of the reviewed finished medical advertisement sample, the medical institution shall resubmit a review application.

Consequences of Failure to Comply With Regulations

      For detailed regulatory requirements and penalties, please refer to Chapter 5 of the “Advertising Law of the People’s Republic of China” and the “Interim Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Foods for Special Medical Purposes”.

      For example, according to article 26, anyone who falls under any of the following circumstances shall be punished in accordance with Article 58 of the “Advertising Law of the People’s Republic of China”:

  • Violate the provisions of Article 2, Paragraph 2 of the Measures: publish advertisements for drugs, medical devices, health foods and foods for special medical purposes without review;
  • Violate the provisions of Article 19 of the Measures or continue to publish advertisements for drugs, medical devices, health foods and foods for special medical purposes if the advertising approval number has expired;
  • Violate the provisions of Article 20 of the Measures and fail to publish advertisements for drugs, medical devices, health foods and foods for special medical purposes in accordance with the approved content.

      According to Article 58 of the “Advertising Law of the People’s Republic of China”, anyone who commits any of the following acts shall be ordered by the market supervision and management department to stop publishing advertisements. The advertiser shall be ordered to eliminate the impact within the corresponding scope, and a fine of not less than one time but not more than three times the advertising fee shall be imposed. If the advertising cost cannot be calculated or is obviously low, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed. If the circumstances are serious, a fine of not less than three times but not more than five times of the advertising cost shall be imposed. If the advertising cost cannot be calculated or is obviously low, a fine of not less than RMB 200,000 but not more than RMB 1 million may be imposed. Besides, the business license may be revoked, the advertising review approval document shall be revoked by the advertising review authority, and the advertising review application shall not be accepted within one year.

Laws and Regulations Related to Medical Device Advertising

  • “Advertising Law of the People’s Republic of China”
  • “Measures for the Administration of Medical Device Advertising”
  • “Regulations on the Supervision and Administration of Medical Devices”
  • “Medical Device Advertising Review Implementation Specifications”
  • “Anti-Unfair Competition Law of the People’s Republic of China”
  • “Notice of the State Administration for Market Regulation on In-depth Rectification of Internet Advertising”
  • “Interim Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Foods for Special Medical Purposes”