Equivalence Recognition: The Eight Reduced Documents

1. Key takeaways

Article 17 of the main regulation establishes a conditional reduction mechanism: for EMB that have been manufactured, registered and already sold in a country whose registration system has been recognised as equivalent, the Ministry of Health requires only eight documents (17.2.1 to 17.2.8), namely the application form, technical and medical specifications, the CLV, the radiation source authorisation where applicable, the label, payment of fees, the third-party manufacturing contract, and the power of attorney. What is waived are the heavy documents such as the BPM certificate and clinical evidence. However, Article 17.3, as amended in 2024, retains the right of the Ministry of Health to demand missing documents at any time, and it identifies three break situations in which the missing documents must be completed at renewal or change.

2. Legal basis

The table below lists the recognition basis, the eight-item reduced list item by item, the 2024 amendment to Article 17.3, and the Annex B procedure on which recognition rests.

3. Expert insights

Insight 1: Article 17.1 writes the recognition basis as three items, and all three are standards that can be argued about rather than mechanically proven. Item 17.1.1 refers to experience, knowledge and existing trust in the relevant measures; 17.1.2 requires that the norms of the recognised country objectively demonstrate that they achieve an appropriate level of protection; 17.1.3 requires that the sanitary control system of the recognised country enforces these requirements effectively and efficiently. All three carry room for judgement, so recognition does not happen automatically and must go through the Annex B procedure. This also explains why the regulation calls recognition a reconocimiento, an acknowledgement, rather than an automatic equivalence.

Insight 2: The eight-item list retains the CLV, the label and the power of attorney, and these three are precisely the carriers of the source-country identity. Compared with the eleven categories of Article 11, what is waived are the BPM certificate under Article 11.5 and the clinical evidence of Clase 3 and 4, while the radiation source authorisation is retained at 17.2.4. The CLV at 17.2.3 and the label at 17.2.5 are expressly retained. This design of reducing the burden without reducing identity verification is exactly why the 2024 amendment wrote the CLV issuing country into the break situations of Article 17.3: the CLV is the direct credential for judging whether the product still enjoys the protection of mutual recognition.

Insight 3: The precondition for applying Article 17.2 is the three parallel conditions of having been manufactured, registered and sold in the recognised country. The source text reads EMB fabricados, registrados y de venta en los países. None of the three states can be missing: a product registered in the recognised country but not sold there, or sold there but manufactured in a third country, does not automatically qualify for the eight-item list. This parallel condition is the first sieve a company should apply when self-checking whether the reduced list is available.

Insight 4: The hidden cost of the reduction is the uncertainty of demands for completion at any time. Article 17.3 as amended states expressly that the Ministry of Health may, during the registration process or after registration, require the submission of any waived document on technical and scientific grounds. The meaning is that the documentary obligations of a dossier filed on the eight-item list have not disappeared; they have only been deferred. Companies should budget and schedule projects on the assumption that the BPM certificate and clinical evidence may be demanded at any time, rather than treating the reduction as a permanent exemption.

4. Practical recommendations

• Self-check eligibility for the reduced list against the three parallel conditions of Article 17.2: manufactured, registered and sold in the recognised country.
• File on the eight-item list (17.2.1 to 17.2.8) while keeping the BPM certificate and clinical evidence ready in parallel, to answer a demand under Article 17.3.
• Bring the CLV issuing country into change management: before switching the issuing country, assess whether the completion obligation of Article 17.3 is triggered, as detailed in article 19 of this series.
• Track the status of recognition resolutions under Annex B, since revocation of a recognition triggers the completion obligation.
• Allocate the completion obligation to the licence holder in the commercial arrangements, and agree the deadlines and cost bearing for document provision in the contract.

5. Verification checklist

• □ Self-check completed against the three conditions of manufactured, registered and sold
• □ Source country confirmed to be on the current equivalence recognition list
• □ Dossier organised on the eight-item list, 17.2.1 to 17.2.8
• □ BPM certificate and clinical evidence ready for a demand under Article 17.3
• □ CLV issuing country recorded and brought under change monitoring
• □ Revocation status of Annex B recognition resolutions tracked

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