RTCR 505:2022 Exclusions: Nine Items Outside the Regulation

1. Key takeaways

Article 2.2 of the main regulation lists nine items to which it does not apply: medicinal products, human blood and blood-derived products, cosmetics, human organs, tissues, cells and their derivatives, general laboratory articles or articles for purely research purposes (unless the manufacturer specifically designates them for IVD examination), internationally certified reference materials, materials for external quality assessment, medical gas piping systems assembled on site in a health institution and permanently embedded in its structure, and customs release authorizations (desalmacenaje) for unregistered EMB with clinical research as the sole purpose. These nine exclusions are exhaustive; products not on the list enjoy no exclusion.

• Nine exhaustive exclusions under Article 2.2 of RTCR 505:2022.
• Article 2.2.5 contains an exception to the exception: manufacturer-designated IVD use brings research articles back into scope.
• Article 2.2.9 is the only procedural exclusion, covering desalmacenaje authorizations for clinical-research-only unregistered EMB.
• Article 24.2 prohibits registering products manufactured from human tissues or their derivatives, except IVD quality-control reagents.
• The medical gas exclusion (2.2.8) requires on-site assembly, permanent embedding and a piping system, all three.

2. Legal basis

The provisions below reproduce the nine exclusion items of Article 2.2, together with the prohibition in Article 24.2 and the definition of desalmacenaje that support their interpretation.

3. Expert insights

Insight one: Article 2.2.5 is an exception to the exception and is the easiest to misjudge. The provision excludes general laboratory articles or articles intended solely for research purposes, but is immediately followed by a proviso: “salvo cuando, por sus características, el fabricante los destine específicamente a su utilización para un examen diagnóstico in vitro”. Where the manufacturer, by reason of the product’s characteristics, specifically designates it for IVD examination, the article returns to the jurisdiction of the main regulation. The key to the determination therefore lies not in the product form (both can be a tube or a bottle of reagent) but in the manufacturer’s intended-use statement. In practice, a single product insert or a website use description is enough to pull a research-use article back into regulation. This provision points in the same direction as Article 2.1.7, which brings drug-containing and internal-quality-control IVDs into scope.

Insight two: Article 2.2.9 is the only procedural exclusion; what is excluded is a licensing matter, not a product. The other eight items exclude product categories; item 2.2.9 excludes the sanitary licensing matter itself, namely the customs release authorization for unregistered EMB whose sole purpose is clinical research. Two layers follow: first, unregistered EMB can enter the country, but only through this dedicated authorization; second, the purpose of the authorization is strictly limited to clinical research, and any import for commercialization or use in individuals remains governed by Article 2.1.2. When importing clinical trial materials, companies must go through this channel and must not process them as ordinary imports under the label of samples.

Insight three: Article 2.2.4 (exclusion) and Article 24.2 (prohibition) form a two-part treatment of human-derived materials. Article 2.2.4 removes organs, tissues, cells and substances of human origin and their derivatives from the scope of the main regulation; Article 24.2 then prohibits registration of products manufactured from human tissues or their derivatives, while opening one gateway: reagents used as quality controls for IVD testing may be registered. The combined conclusion of the two provisions is that human-derived material products have no routine registration route in Costa Rica, and the sole exception is IVD quality-control reagents.

Insight four: Article 2.2.8 excludes a specific form of piping system, not all medical gas systems. Three conditions must be met cumulatively for the exclusion: assembly on site in a health institution, permanent embedding in that institution’s structure, and being a medical gas piping system. On this basis, factory-prefabricated medical gas equipment, mobile gas supply units, and piping components that are not permanently embedded are all outside the exclusion. This precision shows that the exclusion clauses of the main regulation are narrowly drawn; there is no textual basis for expansive interpretation.

4. Practical recommendations

• For research-use products at the characterization stage, obtain a written intended-use statement from the manufacturer; if the statement includes IVD use, treat the product as regulated (proviso to Article 2.2.5).
• Route clinical trial materials through the dedicated Article 2.2.9 authorization channel and state expressly in the filing that clinical research is the sole purpose.
• For human-derived material products, first test against the Article 24.2 prohibition; only IVD quality-control reagents can proceed through registration.
• Check medical gas systems item by item against the three conditions of on-site assembly, permanent embedding and piping system; failing any one, treat the item as an EMB.
• Convert the nine exclusions into a determination sheet with documented reasons for each exclusion, so that the position can be evidenced in later verification.

5. Verification checklist

• □ Exclusions applied item by item under 2.2.1–2.2.9 with reasons retained
• □ Written manufacturer intended-use statement obtained for research-use articles (2.2.5)
• □ Clinical research materials routed through the 2.2.9 customs release authorization, not ordinary import
• □ Human-derived material products checked against the Article 24.2 prohibition and the IVD quality-control exception
• □ Medical gas systems checked against the three exclusion conditions (2.2.8)
• □ Reference materials and external quality assessment materials filed separately (2.2.6, 2.2.7)

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