Advertising Rules Under Article 6.5.4: One Standard, Three Prohibitions

1. Key takeaways

Article 6.5.4 of RTS 11.03.02:21 establishes one general requirement and three prohibitions for device advertising and promotion. The general requirement is that advertising must conform to the characteristics or specifications of the device and to the conditions of the sanitary registration authorisation. Prohibition (a) forbids attributing to a device preventive, therapeutic, rehabilitative or other qualities that go beyond the manufacturer’s intended use and the authorisation granted by the competent authority. Prohibition (b) forbids stating or suggesting that use of a product or receipt of a service is a determining factor in changing human behaviour. Prohibition (c) forbids expressly or implicitly attributing to a product components, parts or properties that it does not possess.

• The reference point for advertising content is the Salvadoran registration, not the claims approved in other markets.
• The three prohibitions address different failures: overreach beyond authorised use, implied behavioural determinism, and invented attributes.
• Advertising authorisation is priced by medium in four tiers, and the internet is a separate tier at USD 96.00.
• Software features are a common source of exposure under prohibition (c), because claimed modules may not exist in the product.
• Disinfectant claims must be supported by the efficacy validation report filed under Article 6.3.2.4 (i).

2. Legal basis

The provision sits in the post-market chapter of the device regulation, and the fee schedule adds a medium-by-medium authorisation charge. The table below sets out the operative text, the supporting validation requirement for disinfectants, and the four advertising tiers. Note that the article constrains content while the schedule prices permission, so a campaign can be fully compliant in substance and still be unauthorised in form.

3. Expert insights

The first point is that the general requirement anchors advertising to the content of the registration authorisation. The opening sentence of Article 6.5.4 requires advertising to conform to the characteristics or specifications of the device and to the conditions of the authorisation granted in the sanitary registration. The boundary is therefore not what the manufacturer claims in other markets, but what this particular Salvadoran registration has approved. An indication approved elsewhere that does not appear in the Salvadoran registration cannot be promoted in El Salvador. This single sentence does most of the work in practice, and it is the sentence most often overlooked when a regional campaign is adapted for local use without revisiting the local file.

The second point is that prohibition (a) is the live wire in device advertising. The three qualities named in the text, preventive, therapeutic and rehabilitative, are precisely the words that habitually appear in promotional material for consumables and equipment. The test is whether the claim exceeds the manufacturer’s intended use and the authorisation granted by the authority. That makes the first step of any review a return to the intended use statement in the registration file, not a discussion about tone or emphasis.

The third point is that prohibition (c) targets invention, and sits alongside the exaggeration addressed by (a). Where (a) governs making an existing use sound larger than it is, (c) governs claiming components, parts or properties that the product does not have at all. These are different kinds of breach, yet they are frequently cited together during review, particularly for software products, where a claimed functional module that does not exist falls squarely within (c).

The fourth point is that advertising authorisation is charged in four tiers by medium, with the internet standing alone. Section 8 of the Tarifario divides the charge into television and other audiovisual media excluding the internet at USD 204.00, radio at USD 144.00, the internet at USD 96.00, and print and other advertising means including promotional items and promotions at USD 48.00. The parenthetical exclusion of the internet is what makes the USD 96.00 tier applicable to online advertising on its own. For companies whose promotion is predominantly digital, this is a real and recurring cost line rather than an incidental one.

4. Practical recommendations

• Compare advertising copy sentence by sentence against the intended use statement in the registration file, and remove or rewrite anything that extends beyond it.
• Avoid the terms preventive, therapeutic and rehabilitative where they exceed the authorised intended use.
• Check every functional claim for software products against the modules actually delivered, so that the claim does not fall under prohibition (c).
• Base disinfectant antimicrobial claims on the efficacy validation report required by Article 6.3.2.4 (i).
• Budget the advertising authorisation fee by medium: television USD 204.00, radio USD 144.00, internet USD 96.00, print and promotional material USD 48.00.
• Make advertising compliance review a separate gate before launch, rather than a decision taken inside the marketing function alone.

5. Verification checklist

• □ Advertising copy has been compared line by line with the registered intended use
• □ Preventive, therapeutic and rehabilitative language beyond the authorisation has been removed
• □ Software feature claims have been checked against delivered modules
• □ Disinfectant antimicrobial claims are supported by a validation report
• □ Advertising authorisation fees are budgeted by medium
• □ Advertising compliance review is established as a separate gate

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com