Six Medical Specification Items: Intended Use, Complications and Contraindications

1. Key takeaways

Article 11.4.3 of the main regulation divides the medical specifications into six items, lettered (a) through (f), submitted alongside the technical specifications: the intended use, medical indication or procedure of the product (a); for products containing medicinal substances, the name of the drug, its indications, contraindications and possible adverse reactions (b); the precautions to be taken during use (c); the instructions or recommendations to be given to the patient (d); the complications that use of the product may produce (e); and the possible contraindications (f). Together, these six items constitute Costa Rica’s complete requirement for clinical use information.

• Item (a) must describe the use both generally and specifically — a generic one-line statement is not enough.
• Item (b) is exclusive to drug-containing devices and moves the core elements of a drug label into the device dossier.
• Items (e) and (f) are separate safety dimensions: complications during use versus situations in which the product must not be used.
• The regulation’s verbs — enumerar, indicar — require concrete itemised entries, not cross-references to the instructions for use.
• Once approved, the medical specifications become the anchor for change filings under Articles 18.14 and 18.15.

2. Legal basis

The six-item list sits in Article 11.4.3 of RTCR 505:2022 and is connected to the scope of the regulation and to the change provisions by the entries below.

3. Expert insights

Insight 1. Article 11.4.3 a) requires both layers — de forma general y específica, general and specific. The Spanish text reads Indicar de forma clara y extensa el uso, indicación médica o procedimiento de forma general y específica del producto. The meaning is that the applicant must state both the overall positioning of the product’s use and the concrete medical indications or procedures it serves. A summary formulation such as for in vitro diagnosis or for surgical procedures, on its own, does not meet the requirement; the specific indications and procedures must be spelled out.

Insight 2. The complications of item (e) and the contraindications of item (f) are two different safety dimensions, and both must be listed. Item (e) targets the adverse outcomes that may occur during use (complicaciones); item (f) targets the situations in which the product should not be used (contraindicaciones). The provisions use the verbs Enumerar (enumerate) and Indicar las posibles (state the possible), both of which demand concrete itemised entries. Referring the reviewer to the instructions for use instead of listing the entries does not satisfy the text.

Insight 3. Item 11.4.3 b) is the drug-device item, and it interlocks with Article 2.1.8. Article 2.1.8 brings into the main regulation those EMBs that incorporate a medicinal substance, with the drug acting in an ancillary or assisting role in the human body; item 11.4.3 b) then requires their medical specifications to list the drug that has been added together with that drug’s indications, contraindications and possible adverse reactions. In substance, this item moves the core elements of a drug label into the device dossier, and it is the additional content that drug-containing dressings and drug-coated products must prepare.

Insight 4. The medical specifications are the anchor for subsequent changes: Articles 18.14 and 18.15 both take them as the object of the filing. Article 18.14.1 requires medical specifications containing the new use when the intended use is changed or extended; Article 18.15.1 requires new medical specifications when the medical specifications themselves change, and Clase 3 and 4 must additionally submit clinical evidence supporting the new medical specifications under Article 18.15.2. The implication is that once the medical specifications are approved, any substantive change to them is a regulatory filing matter, not an internal document update.

4. Practical recommendations

• Write the medical specifications in sections corresponding to items (a) through (f), each section numbered and self-contained, so the reviewer can check them item by item.
• Cover both layers for use and indications — general plus specific — and avoid summary formulations.
• For drug-containing products, list the drug name, indications, contraindications and adverse reactions under item 11.4.3 b).
• List complications and contraindications entry by entry, without substituting references to other documents.
• Bring the medical specifications into change management: where the use or the medical content changes substantively, file under Articles 18.14 and 18.15.

5. Verification checklist

• □ Medical specifications written in sections for items (a) to (f)
• □ Use and indications cover both the general and the specific layers (a)
• □ Drug-containing products list the four drug-related items (b)
• □ Precautions during use are stated (c)
• □ Patient instructions are provided (d, where applicable)
• □ Complications and contraindications are listed entry by entry (e, f)
• □ Medical specifications are integrated into change management (18.14, 18.15)

Related reading: [Technical specifications twelve items: Articles 11.4.1 a) to l) of the main regulation](/costa-rica-medical-device-registration/technical-specifications-twelve-items/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/) | [Three-stage classification rule for combination products](/costa-rica-medical-device-registration/combination-products-medicine-delivery-rule/)

Regulatory information verified as of October 29, 2026.

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