In Mexico, activities related with medical devices such as advertising, manufacturing, importation, exportation, storage, disposal and others are strictly regulated by COFEPRIS. In this article, we will explain the characteristics of medical device advertising and general requirements for notifications and permits.
What is regulated?
The publicity of medical devices are regulated by the General Law of Health, the Health Supplies Regulation and the Regulation from the General Law of Health in Advertising Affairs. The aim of the above-mentioned regulations is to control the publicity regarding the existence, quality, and characteristics of any medical device, including the promotion, marketing and use.
Types of advertising
There are two advertising classifications for medical devices:
- For Healthcare professionals only: This kind of ads can only be targeted to Healthcare professionals including physicians, technicians, nurses and personal related exclusively within the healthcare sector. In this case, the publicity includes technical information regarding a medical device in a form of brochures, catalogues, posters, videos, webpages, and other specialized media.
- General public: For this second classification, the advertisements can be focused on the general population. This kind of publicity can be in a format of leaflets, signs, posters, magazine ads, TV, radio commercials, internet multimedia and other mainstream media.
Advertising notice vs permit
There are two ways to legally launch publicity for medical devices in Mexico:
- Advertising notice: This type of procedure is necessary when the ads are intended for Healthcare professionals. The request must be submitted to COFEPRIS with the code COFEPRIS-02-001-A at least 15 days before releasing the ad for each product and distribution channel. The submission number must be included in the final advertising.
- Advertising permit: This authorization is needed in ads for the general public. The request must be approved by COFEPRIS before launching the ad campaign. This permit must be requested under the code COFEPRIS-02-001-B for each product and distribution channel. The authorization number must be later included in the final version of the advertisement.
It is worth mentioning, that one of the key points to consider between a permit and a notice, is that the advertising notice does not require to be approved by COFEPRIS. Nevertheless, the authority is able to eventually inquire about the advertising notice.
There are some common requirements to submit an advertising notice or requesting an advertising permit:
- COFEPRIS official format
- Publicity draft (screenshots for multimedia)
- Bibliographic references or technical support for every claim in the ad
- Sanitary Registration copy, when applicable
- Warehouse notice
In addition, payment of fees is required for advertising permits, and the amount depends upon the advertising media.
Some general points must be considered for advertising medical devices in Mexico:
- The advertising must contain only general characteristics of the medical device according to its intended use as mentioned in the approved Sanitary Registration, when applicable.
- COFEPRIS has the authority to determine if the advertising can be directed to the general population or Healthcare professionals only. This will be clearly indicated in the approved Sanitary Registration issued for each medical device.
- Publicity for the general population must be clear and understandable. It must avoid self-treatment practices and include warnings and precautions to be taken if the device is risky. Besides, the recommendation about consulting and following the physician advice, should be always included.
- Hygienic products require especial caution when attributing preventive, therapeutic or rehabilitation characteristics not demonstrated. It is also necessary to state warnings for topic or internal use.
As a conclusion, Medical Device advertising in Mexico is highly regulated by COFEPRIS because of the associated public health risk. It is worth mentioning that whether through permits or notices, there are still several factors to consider for ads that can become complex in advertising terms (e.g. promoting several products from the same or different manufacturer/Holder). If you have additional inquiries regarding this topic, please contact us at firstname.lastname@example.org