Outdoor and place-based advertising for medical devices in China

Regulated device advertising needs prior review and label consistency

Legal requirement — paraphrased

Applies when: The offer is a regulated device, including an IVD or software where classified as such.

For a regulated medical device, use the registered or filed product basis and the applicable advertising review. Personal-use devices have specific instruction and warning requirements. Determine whether a test or medical software is a device and whether the campaign also promotes a medical institution.

Sources: SAMR Order 21 — regulated product advertising review; Advertising Law of the People’s Republic of China

Exclude efficacy guarantees, cure rates and prohibited comparisons

Legal requirement — paraphrased

Applies when: The message is medical, drug or regulated-device advertising.

Advertising Law Article 16 prohibits efficacy or safety guarantees, cure/effectiveness rates, specified comparisons and endorsement-based recommendations in medical, medicine and device advertising. An accurate study statistic is not automatically suitable promotional copy.

Classify the offer before applying this rule: device software and an ordinary wellness app do not necessarily follow the same route.

Sources: Advertising Law of the People’s Republic of China · Advertising Law Article 16

Track approval expiry and the approved creative version

Legal requirement — paraphrased

Under Order 21, advertising approval expires with the earliest relevant underlying product or production document; where those documents have no expiry, the advertising approval lasts two years. Changes to approved content require renewed review. Do not treat a shortened or rearranged video as automatically covered by the original approval.

Sources: SAMR Order 21 — regulated product advertising review

Keep the applicable warning visible throughout video

Legal requirement — paraphrased

SAMR Order 21 requires category-specific warnings and the advertising approval number. OTC ads need the OTC symbol and the instruction to purchase/use according to the leaflet or pharmacist guidance; personal-use devices have their own instruction and applicable contraindication notice. Health-food ads must state that the product is not a medicine and cannot replace medicine for disease treatment, and identify suitable and unsuitable users. Required prominent information must remain visible throughout video, with clear type and colour.

Sources: SAMR Order 21 — regulated product advertising review · Articles 5–10; use the exact Chinese wording from the approved creative.

Check the complete consumer-facing message

Regulator guidance

Advertising must be truthful and clear. Review the accuracy of stated functions, benefits, provider details, prices and promises under the Advertising Law. Sector review requirements and prohibited claims continue to apply even when the advertiser identifies the commercial nature of a message.

Sources: Advertising Law of the People’s Republic of China

Do not apply the ordinary-data threshold to health data

Regulator guidance

The CAC identifies medical and health information as sensitive personal information. Its under-100,000-person ordinary-data exemption excludes sensitive data. Subject to stated exemptions, a non-critical-infrastructure operator exporting sensitive information for fewer than 10,000 people must use the standard-contract or certification route; at least 10,000 requires a security assessment. Important data and critical-infrastructure operators have separate assessment triggers. Count people from 1 January and document the specific exemption, if any; an advertising consent checkbox does not establish a transfer mechanism.

Sources: Cross-border data provisions — official explanatory FAQ

Check public exposure and legibility

Editorial recommendation

Review the actual viewing distance, dwell time and location. Treat the placement as public-facing and establish whether the required information can fit legibly; do not shorten mandatory wording without a supported exception.

Medical Devices & Medtech: prepare the review

Editorial recommendation

Identify the device, intended purpose, risk class and intended users. Check local market status and any advertising review or public-promotion restriction. Use performance evidence for the advertised model and purpose; distinguish registration from approval.

Keep a traceable campaign decision

Editorial recommendation

Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.