Annex B: Registration System Equivalence Procedure and Revocation

1. Key takeaways

Annex B of the main regulation sets out the procedure for the recognition of the equivalence of registration systems (Procedimiento para el reconocimiento de la equivalencia de los sistemas de registro), that is, how the Ministry of Health judges whether the registration system of another country reaches an equal or higher level of protection. The procedure runs from Article 7.1 to Article 7.5, and Article 7.5.2 governs revocation after recognition: the Ministry of Health may revoke a recognition immediately by means of a resolution (revocarlo en forma inmediata por medio de una resolución). Article 17.1 of the main regulation states the international law basis of this procedure expressly as Article 6.1 of the WTO Agreement on Technical Barriers to Trade.

2. Legal basis

The provisions below assemble the international law anchor, the Annex B procedure and its revocation clause, the benefit and the break of recognition, and the domestic instruments that implement and transition the framework.

3. Expert insights

Insight 1: Annex B deals with a system, not a product, and this is the first dividing line for understanding mutual recognition. The title of Annex B is the procedure for the recognition of the equivalence of registration systems: the object of recognition is the registration and conformity assessment system of the authority of another country, not any particular product. Recognition therefore does not produce the effect of automatic approval of a product; it produces only the reduction of documents under Article 17.2. Reading mutual recognition as product-level automatic approval is the most common misalignment in secondary commentary on this regulation.

Insight 2: Article 17.1 cites Article 6.1 of the TBT Agreement, placing the act of recognition within the framework of international law. The source text states expressly that this is done de conformidad con lo establecido en el artículo 6.1 del Acuerdo sobre Obstáculos al Comercio de la Organización Mundial del Comercio (OMC). Article 6.1 of the TBT Agreement deals with the recognition by central government bodies of conformity assessment results in other Members. This citation shows both that Costa Rica treats recognition as a trade facilitation obligation, and that the recognition standards must comply with the requirements of transparency and non-discrimination.

Insight 3: The immediate revocation clause of Article 7.5.2 makes recognition revocable and without a transition period. The source text reads that the Ministry may en forma inmediata revocarlo por medio de una resolución, that is, the Ministry of Health may revoke the recognition immediately by means of a resolution. Combined with the second paragraph of Article 17.3, the consequence of revocation is that affected registrations must complete the missing documents at renewal or post-registration change. Taken together, this means the benefit that recognition brings is a revocable convenience, and companies should not enter it as a fixed item in long-term cost models.

Insight 4: Article 6 of the approving decree resolves the continuity of existing recognitions in the transition between the old and new law. The provision replaces, wholesale and with effect from the date RTCR 505:2022 entered into force, all references to DE 34482-S in administrative decrees and in instruments on the recognition of the equivalence of the registration and control system for EMB with references pointing to the new regulation. This treatment prevents existing recognition instruments from lapsing after entry into force because they cite the old law. It also means that the substantive standards of existing recognition instruments are henceforth read under the new regulation, including the Annex B procedure and the revocation mechanism of Article 7.5.2.

4. Practical recommendations

• Position mutual recognition as system recognition plus document reduction, never as a basis for automatic product approval, and do not write approval promises to customers on that footing.
• When querying the Ministry of Health, request the resolution on which the recognition is based rather than a general explanation, and record the resolution number and date.
• Establish monitoring of the recognition status: as soon as a revocation resolution under Article 7.5.2 appears, activate the completion contingency under Article 17.3 immediately.
• Treat the recognition benefit as a variable item in the cost model, running sensitivity and scheduling analysis on the assumption that it may be withdrawn.
• Check existing recognition instruments: pursuant to Article 6 of the approving decree, their references to DE 34482-S have been replaced wholesale by references to RTCR 505:2022.

5. Verification checklist

• □ Confirmed that mutual recognition is system recognition, not product approval
• □ Recognition resolution number and date recorded
• □ Monitoring mechanism for revocation under Article 7.5.2 established
• □ Completion contingency pre-staged under Article 17.3
• □ Reference replacement in existing recognition instruments checked against Article 6 of the approving decree
• □ Cost model treats the recognition benefit as a variable item

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