China to Regulate Medical Device Advertising

The State Administration for Market Regulation (SAMR) are developing new standards and processes for the regulation of medical device advertisements in China. The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers. The new regulations will also include processes for advertisements pertaining to pharmaceuticals, food supplements, and cosmetics.

On May 29th, the State Administration for Market Regulation in China released a new draft guidance document, ‘Measures for the Administration of Advertisement Review’ for comment. Upon implementation, the new policy will replace the 2019 ‘Interim Measures for the Review and Administration of Advertisements of Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes’. While there is no guidance on the implementation date, it is expected within the next 12 months.

Read on for a summary of the document, highlighting important aspects of proposed medical device advertising requirements.

Trends in Medical Device Advertising Regulations in Asia

There is an increasing trend in Asia to regulate advertising material for registered medical devices but requirements vary widely across countries. For instance, in Thailand, advertising material must be reviewed and approved by the Thai FDA in advance of use. In Vietnam, a medical device license holder must upload advertising material to the Ministry of Health online portal. In the Philippines and Hong Kong, manufacturers must adhere to advertising guidelines and would face fines or penalties if a valid complaint is filed.

The Chinese regulations seem to be following a stricter review policy whereby all advertising material (e.g., print, digital, or video) for all registered medical devices (e.g., for home or professional use) must go through an approval process before use.

Who’s Responsible for Advertising Compliance?

According to the draft policy, the advertising sponsor is responsible for the accuracy and compliance of medical device advertisements.

Overall, the advertisement must be accurately based on the claims approved in the medical device registration process. This means that advertisers need to understand thoroughly the medical device’s scope of use when the manufacturer registered it with the drug regulatory department, and what was approved.

All advertising must disclose the product’s name, contraindications, and precautions as outlined in the registration certificate. There must also be a conspicuous label stating: “For details of contraindications or precautions, please refer to the instruction manual.” Medical devices intended for personal use should also include another statement in their advertising: “Please read the product manual carefully or purchase and use under the guidance of medical personnel.”

All advertising must also clearly include the approval number of the advertisement, as given by the review agency. They’re also responsible for making sure that links or QR codes within the ads are correct and legal.

Applying for Ad Review

The registration certificate (IMDRC) holder for medical devices can apply for advertising approval or authorize production and operations enterprises to apply for advertising review. They may also entrust an agent to handle the application.

In order to apply, they must submit the application to the review agency in the jurisdiction where the manufacturer or import agent is located. They’ll need to complete an Advertisement Review Form and provide an advertisement sample. Documentation required will include:

• Subject qualification-related materials, e.g. registration documents
• Product registration certification documents, filing product labels and instructions, and production license documents
• Effective certification materials related to intellectual property rights

Ads that are approved can be released nationally.

Restrictions on Medical Device Advertising

Some important aspects of medical device advertising include the restrictions placed on all medical advertising. Health equipment can’t be introduced on live webcasts, be recommended by webcast hosts or be targeted at minors. Additionally, there are restrictions on mentioning government or military agencies or personnel in advertising or using minors to advertise.

The advertisement also can’t make promises that violate scientific laws, such as promising a cure or implying an item is necessary. Items can’t be advertised as guaranteed, free or superlative.

Medical devices for special purposes are also forbidden from advertising, including drug rehabilitation, military special-need devices or any device whose sale is stopped due to law.

Application Review

All advertising for medical devices must be reviewed by the Drug Supervision and Administration of the provincial, autonomous region or municipality where the manufacturer or import agent is located, according to Article 4 of the draft policy.

Applications will be received in person or through mail, fax, email, or e-government platforms. The review authority will be allowed five business days to accept the application, although they’re encouraged to accept it immediately if possible. They must notify the applicant if the application is incomplete within five working days and include a correction time.

The review agency will have 10 working days from the date of acceptance to review the application. They will then decide and provide an approval number for the advertisement.

If an ad is rejected, the agency will provide a disapproval decision and explain why they rejected the ad. The applicant will then be able to apply for administrative reconsideration or file an administrative lawsuit. The approval will be posted on the review agency’s website for public review within 10 working days of the decision as well.

Approval numbers are valid for two years.

Revoking or Changing Approval

Advertising approval can be revoked for a number of reasons, including:

• The qualification certificates are revoked or canceled
• Registration certification documents, filing certificates, or production license documents are revoked or canceled
• Product functions, scope, use, mechanism, structure, etc. which have changed are found to be inconsistent with the content of the advertisement
• Other circumstances stipulated by law and administrative regulations

If an ad needs to be changed, the applicant will need to submit another application for approval, unless they’re making minor adjustments, such as to the overall design of the ad (font, background color) or changes to certain information within the ad (QR codes, website addresses, prices) that don’t affect the overall message of the ad as it relates to the product.

Penalties

There are different penalties issued for different specific provisions, but they typically involve monetary penalties. For instance, if an advertiser is found to be in violation of provisions six to 10 of Article 11 of the draft policy, the publishers will be fined less than three times the illegal income, not to exceed 30,000 yuan, or a fine of less than 10,000 yuan if no illegal income has been made.

Contact Us for More on Advertising Your Medical Device in China

The policy is still under review and a publication date has not yet been set. Asia Actual is monitoring the document’s publication and working to understand the scope of advertising registration for our clients in China.

Contact us today. We can help navigate the complex medical device registration requirements for medical device and IVD distribution in China, including advertising.