We have discussed in previous articles about the regulations for advertising medical devices in Mexico and explained the particulars for the ads targeted exclusively to healthcare professionals. In this third article, we will close the topic explaining the details of advertisement directed to the general public.
How is it regulated?
Advertising medical devices for the general population is more complex than for healthcare professionals, due to the following reasons:
- There will be more persons potentially exposed to the ads
- The people receiving the ads may not be educated or trained on health topics
- More and bigger channels are used to distribute the advertisement
Thus, is understandable that advertising medical devices for general populations is a more strictly and regulated activity requiring advertising permits to avoid risks to the public health.
Which products can be advertised?
Not all medical devices are eligible to be advertised to general publics. Articles 52 and 53 of the Regulation from the General Law of Health in Advertising Affairs indicates that the Ministry of Health (with the aid of COFEPRIS) will specify for each medical device if it can be advertised for the general public or healthcare professionals only, according to the intended use of the product declared when requesting the Sanitary Registration in Mexico.
Characteristics that this type of advertising must have
Articles 54, 55 and 56 of the mentioned regulation indicates the following regarding the ads for the general public:
- Be clear, concise, and easily comprehensive
- Be educative with the aid of captions
- Contain warnings and precautions to avoid health risks
- Include messages to avoid self-treatment, when applicable
Additionally, for hygienic products, the ads should avoid indications for use not clinically tested.
Subtypes of ads requiring permits
We can find catalogs, brochures, and posters to promote medical devices for the general population. In addition, we can find mass media such as TV, radio, newspapers, and magazines. However, most companies will prefer digital media such as social networks and entertainment platforms (Facebook, Youtube, etc.) In all cases, ads will need an advertising permit for each product, each campaign, and each channel to avoid fines.
Conclusion
Advertising medical devices for the general public is a strictly regulated activity that will need a special assessment for each case to avoid regulatory noncompliances. If you need support with the promotion of your medical devices, please contact us at contact@veraqueconsulting.com
