Four Risk Classes A, B, C and D under Article 6.3.1

1. Key takeaways

Article 6.3.1 a) of RTS 11.03.02:21 divides devices by risk into four classes: Clase A (low risk), Clase B (medium-low risk), Clase C (medium-high risk) and Clase D (high risk). The basis for classification is the intended purpose, assessed against four criteria: duration of contact with the body, degree of invasiveness, manner of invasiveness, and whether the device releases a drug or energy. The classes are not to be written as I, II or III, and the classification of the country of origin should not be mapped across directly: El Salvador publishes no classification list, and the class is determined by the authority during review on the basis of intended purpose.

Because no list exists, the classification argument is part of the file rather than a reference lookup. A well-argued proposed class helps the reviewer; an unexplained one invites a different conclusion.

• Four classes apply: Clase A, B, C and D.
• Classification follows the intended purpose, not the product category.
• Four criteria are applied, with an open-ended closing phrase.
• No classification list is published and self-classification is not authorised.
• The class determines the depth of the dossier, not the speed of review.

2. Legal basis

Classification sits in Article 6.3.1 a) and depends on the definition in Article 3.14, with further requirements on GMDN codes, validity and reference material in the same article and in Article 8.5. The table sets out the provisions involved.

3. Expert insights

Insight one: the boundary between the classes is drawn by consequence, not by product catalogue. Article 6.3.1 a) defines Clase A as a device not used to protect or sustain life, not used for a purpose of special importance in preventing deterioration of human health, and not presenting an unreasonable potential risk of illness or injury. Clase D is defined as a device used to protect or sustain life, or of substantial importance in preventing deterioration of health, or whose use presents a potential risk of illness or injury. A and D are therefore fixed by consequence, while B and C are fixed by the special controls applied at the manufacturing stage, with B described as medium-low and C as medium-high risk, both requiring such controls to demonstrate quality, safety and efficacy.

Insight two: the four criteria are the working instruments of the review. The provision lists duration of contact, degree of invasiveness, manner of invasiveness and release of drug or energy, closing with the open phrase entre otros, meaning among others. When a class is predicted, each of the four should be answered in writing, because that is the common language in which the question is discussed with the authority. For implantable and energy-emitting devices the release-of-energy criterion is the one most often omitted, and it is also the one most likely to move a product upward.

Insight three: with no published list, the class is not for the applicant to settle. Article 6.3.1 a) supplies criteria only and attaches no classification catalogue, and the text does not authorise self-classification. In practice the authority determines the class during review, with the manufacturer’s statement of intended purpose and technical documentation as the inputs. The same product may therefore be treated differently across applications, which means the quality of the argument, rather than the familiarity of the product, drives the outcome.

Insight four: the class governs the depth of the dossier, not the speed of approval. RTS 11.03.02:21 sets no differentiated review deadline and no differentiated basic document list by class. The difference appears mainly in the clinical evaluation studies under Article 6.3.2.5 i) and in whether fuller sterilisation and biocompatibility evidence is expected. Treating a low class as a reason for a thinner file is the most frequent misjudgement in filing, because the basic document set does not shrink with the class.

Insight five: Clase B and Clase C both depend on special controls at the manufacturing stage. The two middle classes are described by reference to the special controls applied during production, which are required in both cases to demonstrate quality, safety and efficacy, with B placed at medium-low and C at medium-high risk. The difference between them is therefore one of degree rather than of kind, and a Clase B submission is not exempt from manufacturing evidence simply because the risk is lower. Process documentation, validation records and the controls that support sterility or cleanliness remain relevant to both, which is why a file prepared for a Clase C device can usually be adapted downward far more easily than a thin Clase B file can be adapted upward.

4. Practical recommendations

• Write the statement of intended purpose as a reasoned text in Spanish that answers each of the four criteria in turn: contact duration, degree of invasiveness, manner of invasiveness, and release of drug or energy.
• Use Clase A, B, C and D consistently throughout, and remove any reference to classes I, II or III from every document.
• Do not transpose a Chinese or European classification into El Salvador; argue the class afresh under Article 6.3.1 a).
• For Clase C and Clase D products, prepare clinical evaluation studies and full sterilisation and biocompatibility evidence in advance.
• State a proposed class and the reasons for it in the application, so that the reviewer can locate the argument quickly.
• If the class determined differs from the proposal, use the supplementary information procedure under Article 6.3.1 d) rather than withdrawing the file.

5. Verification checklist

• □ The statement of intended purpose answers each of the four criteria
• □ Terminology is consistently Clase A, B, C or D
• □ No classification from the country of origin has been transposed
• □ Clinical evaluation and sterilisation evidence is complete for Clase C and Clase D
• □ The application states a proposed class and the reasons for it
• □ A procedure for responding to supplementary information is in place

Instruments cited: RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), Articles 3.14, 6.3.1 a), b), d) and f), and 8.5.

Regulatory information verified as at 29 October 2026.

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