【EXPERT Q&A】Compliance Information to Be Displayed on Medical Device Product Pages

July 1, 2026  Source: drugdu 30

Drugdu.com expert's response:

 

In accordance with the Quality Management Specifications for Online Sales of Medical Devices which came into effect on October 1, 2025 and relevant regulatory requirements, the following compliance information must be continuously displayed in a prominent position on the medical device product page:

Core Product Qualification Information

Images of the Medical Device Registration Certificate (for Class II and Class III devices) or the Class I Medical Device Filing Information Form, or the link identifier of the corresponding electronic certificate.

General Warning Information

For all medical devices sold online in retail mode, the warning statement "Please carefully read the product manual before purchase and use, or purchase and use it under the guidance of medical personnel" must be displayed.

Exclusive Warnings for Special Categories

For selling contact lenses (contact lenses): The mandatory warning statement "Wearing this product must be fitted by an optometry professional" must be displayed.

For selling hearing aids: The mandatory warning statement "Before fitting a hearing aid, you should undergo a professional examination and hearing test, and use it under the debugging, trial wearing and guidance of a hearing aid fitter" must be displayed.

Supplementary Compliance Content

If the product manual contains special instructions for storage, transportation and safe use, the full product manual of the medical device must be displayed in the form of text, pictures or link identifiers.

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