Decision: “On the determination of the rules of advertising of medical devices marketed in the Republic of Albania”

The Council of Ministers adopted Decision no. 479, dated 13.07.2022 “On the determination of the rules for advertising medical devices marketed in the Republic of Albania” (the “Decision”).

This decision establishes the basic rules concerning the advertising and promotion of medical devices.

Medical device advertising includes any activity that promotes the sale or use of a medical device in any written or verbal form, whether electronic, digital or otherwise, using images and sound, which may not be conducted only by manufacturers and wholesalers of medical devices. as representatives of foreign manufacturers registered in the Albanian commercial register.

On the other hand, medical devices intended for the use of health professionals, i.e. doctors, dentists, pharmacists, veterinarians, nutritionists, etc. are exclusively announced by them.

Medical devices are promoted in accordance with their intended purpose, declared by the manufacturer and allowing sufficient information, which includes elements such as benefits, risks of treatment, costs and reimbursement.

Advertising of medical devices demonstrates compliance with CE marking or FDA certification requirements. Therefore, it is prohibited to affix misleading/misleading signs on the intended use of the device that contradict the CE marking or FDA certification or reduce their appearance and readability.

In addition, comparative advertising must clearly identify the medical devices being compared. A comparison can only be used in an advertisement if the following elements are compared:

• Devices covering products intended for the same use; and

• One or more essential, verifiable and representative characteristics of the medical devices, including their price.

As a general rule, advertising which does not fulfill the conditions defined by the legislation in force and this Decision is prohibited. However, this does not apply to medical devices intended for use in exhibitions, demonstrations, fairs or other activities of this nature. These devices must be accompanied by a visible and clear sign indicating that they cannot be exchanged or put into service.

Finally, violation of advertising rules constitutes an administrative offense and is subject to fines by medical device inspectors. The authenticity and safety of medical device advertising is also monitored by the Ministry of Health and Welfare.

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