Combination Products: The Medicine Delivery Rule of Article 2.3

1. Key takeaways

Article 2.3 of the main regulation gives combination products a three-stage test. First, for products used to deliver medicines, the device part is governed by this main regulation, while the medicine it contains must comply with the current Central American technical regulation on drug registration. Second, where the product is marketed as a single integral product with the medicine, intended exclusively for that combination and not reusable, the whole is governed instead by the medicine rules. The third stage is the implied boundary: products that fail any of the three conditions of the second stage revert to the separate treatment of the first stage. The core of the test is the distinction between a medicine-delivery device and a non-reusable integrated medicine-device product.

• Delivery devices are governed by the main regulation; the medicine they contain follows Central American drug rules.
• Single-integral, combination-exclusive, non-reusable products shift wholly to the medicine rules.
• Reusable delivery devices fail the third condition and their device part still requires sanitary registration.
• EMB incorporating drug substances with ancillary action enter the main regulation via Article 2.1.8.
• Peritoneal dialysis solutions and contrast media are expressly treated as medicines, not classified as EMB (Annex A rule 6 c)).

2. Legal basis

The provisions below reproduce the combination-product rule and the neighbouring articles and rules that delimit when a product follows the device route and when it follows the medicine route.

3. Expert insights

Insight one: the dividing line between the first and second stages is three cumulative conditions; all must be satisfied for the medicine route to apply. The second stage is triggered only where the product forms a single integral product (un solo producto integrado) with the medicine, is intended exclusively for that combination (exclusivamente en tal asociación), and is not reusable (no sea reutilizable). Reusable delivery devices, such as reusable injection pens or refillable infusion pumps, fail the third condition, so their device part remains governed by the main regulation and requires its own sanitary registration.

Insight two: Articles 2.1.8 and 2.3 address two different drug-containing situations. Article 2.1.8 concerns EMB that incorporate a drug substance which acts in the human body in a supporting or assisting role, typically drug-eluting dressings or drug-coated catheters; such products enter the main regulation and proceed through device registration. Article 2.3 addresses the situation where the device serves as a vehicle for delivering a medicine, and the dividing line is whether the drug constitutes the principal intended action of the product. The dossier requirements also differ: for products under 2.1.8, the technical specifications must state, under Article 11.4.3 b), the indications, contraindications and adverse reactions of the added medicine.

Insight three: Annex A rule 6 c) is an express down-classification to medicine status. The rule provides that peritoneal dialysis solutions and contrast media are not classified as EMB and are treated as medicines. This is a detail that easily goes wrong: by physical form and mode of use, the two are often assumed to be devices, but the main regulation expressly assigns them to the medicine rules. When making classification determinations, companies must first check whether Annex A contains an express exclusion before applying the general rules.

Insight four: drug-containing IVDs follow Article 2.1.7, a route different from that for ordinary drug-containing devices. Article 2.1.7 brings “IVDs containing drugs” and “IVDs used for internal quality control (including those containing blood-derived products)” directly under the main regulation, without passing through the three-stage test of Article 2.3. The implication is that drug-containing products in the IVD field always follow the device route; there is no room to shift them to the medicine rules. This aligns with the design of Article 24.2, which permits registration of reagents used as IVD quality controls: IVD quality-control products are deliberately kept within the device channel in Costa Rica.

4. Practical recommendations

• For combination products, first determine whether the product is a medicine-delivery device: if so, the first stage of Article 2.3 applies, the device part is registered under the main regulation, and the medicine part follows the Central American drug rules.
• Then test the three second-stage conditions (single integral product, combination-exclusive, non-reusable); if any one fails, the device part must still be registered.
• Handle drug-eluting dressings and drug-coated products through the Article 2.1.8 device channel, and state the medicine’s indications, contraindications and adverse reactions in the medical specifications under Article 11.4.3 b).
• Classify dialysis solutions and contrast media directly as medicines under Annex A rule 6 c); do not file a device classification.
• Route drug-containing IVDs through Article 2.1.7 on the device channel; do not apply the three-stage test of Article 2.3.

5. Verification checklist

• □ Determined whether the product is a medicine-delivery device (first stage of Article 2.3)
• □ Checked that the three second-stage conditions are all satisfied
• □ Products whose drug substance acts ancillary handled under 2.1.8
• □ Medical specifications include the medicine’s indications, contraindications and adverse reactions (11.4.3 b))
• □ Dialysis solutions / contrast media classified as medicines under rule 6 c)
• □ Drug-containing IVDs routed through 2.1.7 on the device channel

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