RTCR 505:2022 Scope: Eight Regulated Categories under Article 2.1

1. Key takeaways

Article 2.1 of the main regulation states its scope in eight items, covering not only products but also activities: domestic manufacture (2.1.1), import for commercialization or use (2.1.2), sale or commercialization (2.1.3), domestic advertising (2.1.4), labelling (2.1.5), donation (2.1.6), IVDs containing drugs or used for internal quality control (2.1.7), and EMB that incorporate drug substances (2.1.8). Three of these — advertising, labelling and donation — are activities rather than product forms, which means that even where a product itself already holds a registration, its promotional and donation activities remain within the jurisdiction of the main regulation.

• Eight scope items under Article 2.1 cover both products and regulated activities.
• Import under 2.1.2 covers importation for use in individuals, not only for commercialization.
• Donation is a regulated activity (2.1.6) and unapproved donated EMB is prohibited from any use (Article 24.4).
• IVDs containing drugs and IVDs for internal quality control are brought into scope by 2.1.7.
• Labelling is an independently regulated activity (2.1.5), the basis for Clase 1 obligations not being waived.

2. Legal basis

The provisions below reproduce the eight scope items of Article 2.1 and the related articles on donation, advertising and labelling that give each item its regulatory effect.

3. Expert insights

Insight one: Article 2.1.2 sets the jurisdictional threshold for import lower than most countries. The original wording is “La importación de EMB para la comercialización o el uso en individuos”, meaning that import for commercialization or for use in individuals is within scope. Import that is not intended for commercial sale (for example, imports for an institution’s own use, prototype imports, or imports for clinical trial use) is therefore equally subject to the main regulation. The only statutory exit is the customs release authorization (desalmacenaje) for unregistered EMB intended exclusively for clinical research, excluded by Article 2.2.9, which is expressly limited to that single purpose.

Insight two: donation appears in both the scope and the prohibition provisions, a two-way design. Article 2.1.6 brings donation into scope, while Article 24.4 provides that donated EMB not approved by the Ministry of Health is prohibited for any purpose. Definitions 4.13 (Donador) and 4.14 (Donatario) define the donor and the recipient respectively: the donor must be legally established in its home country, and the recipient must be the head or legal representative of a public institution, non-governmental organization or non-profit association legally established in Costa Rica, responsible for the use of the products in the country. The practical implication is that donation is not a waiver channel but a separate channel that requires approval.

Insight three: Articles 2.1.7 and 2.1.8 together settle the characterization of drug-containing devices, but they handle it differently. Article 2.1.7 addresses IVDs containing drugs and IVDs used for internal quality control (expressly including those containing blood-derived products) and brings them directly under the main regulation. Article 2.1.8 addresses general EMB that incorporate drug substances; the condition for inclusion is that the substance, used separately, may be considered a medicinal product and acts in the human body in a supporting or assisting role to the EMB. The difference is that the former concerns the IVD case and the latter general devices, and the latter stresses that the drug action is ancillary. Where the drug action constitutes the principal intended action of the product, the combination-rule treatment of Article 2.3 applies instead (see article 06 of this volume).

Insight four: Article 2.1.5 makes labelling an independently regulated activity, and this is the legal source for Clase 1 obligations not being waived. Labelling is listed as a regulated matter on a par with sale and import. Precisely because of this, Article 2.4 can exempt Clase 1 from the sanitary registration obligation while expressly retaining the five requirements of “import, labelling, advertising, vigilance and control”; the independence of the labelling obligation is already established by Article 2.1.5.

4. Practical recommendations

• At project initiation, tick off the applicability of each of the eight items one by one and file an applicability determination sheet in the dossier as the basis for later characterization and dossier planning.
• Treat non-commercial imports (own use, prototypes, trial units) under Article 2.1.2 as well; only customs release authorizations with clinical research as the sole purpose proceed through the Article 2.2.9 exclusion channel.
• File donation projects through the separate donation channel, and confirm in advance that the recipient meets the qualifications of definition 4.14 (a public institution, NGO or non-profit association legally established in Costa Rica).
• For drug-containing products, first distinguish IVDs from general devices: IVDs proceed under 2.1.7; general devices proceed under 2.1.8 with an assessment of whether the drug action is ancillary.
• Complete compliance review of advertising materials before release (Article 20 and the current advertising regulation for products of health interest); do not conflate advertising with product registration.

5. Verification checklist

• □ Applicability checked item by item against Articles 2.1.1–2.1.8
• □ Confirmed whether the import is non-commercial (2.1.2) and whether the 2.2.9 exclusion applies
• □ Confirmed whether donation is involved (2.1.6) and whether the recipient qualifies under definition 4.14
• □ Drug-containing products characterized under 2.1.7 / 2.1.8
• □ Advertising materials reviewed under Article 20
• □ Labelling checked independently under Article 19 (2.1.5)

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