Equivalence Break Risk After the 2024 Amendment

1. Key takeaways

Article 17.3 of the main regulation, as rewritten by Article 1 of the 2024 amending decree (internal reference MS-AJ-CB-200-2024), is the amendment of the past two years with the most direct impact on existing registrations in Costa Rica. It provides that in three situations missing documents must be completed: first, the Ministry of Health may, on technical and scientific grounds, require completion of any waived document during the registration process or after registration; second, where the equivalence recognition resolution is revoked (cancele la resolución), completion must take place at the renewal or post-registration change stage; third, under a registration that already enjoys mutual recognition, once a CLV issued by the competent authority of a country without a mutual recognition relationship is submitted, the missing documents must be completed. The completion tier follows the class: an IVD in Clase 2 completes under Article 11, Clase 3 under Article 12, and Clase 4 under Article 13.

2. Legal basis

The provisions below reconstruct the amended Article 17.3 paragraph by paragraph, together with the class-specific completion lists and the entry-into-force provision of the amending decree.

3. Expert insights

Insight 1: Before the amendment, Article 17.3 had only two paragraphs; after the amendment a third paragraph was added, and the third paragraph is the genuinely new risk point. The pre-amendment text dealt only with a change of the licence holder country or the manufacturing country and with revocation of the recognition resolution. The amendment adds that, under a registration already enjoying mutual recognition, submitting a CLV issued by a country without a mutual recognition relationship also triggers completion. This addition is a companion design to the amended Article 4.7 in the same batch, which allows the CLV to be issued by the licence holder country, the country of a subsidiary of the licence holder, or the country of a subsidiary of the parent company: while the range of issuing parties widens, whether the issuing country has mutual recognition becomes the new control valve.

Insight 2: The third paragraph turns switching the CLV issuing country from an administrative act into a compliance event. Before the amendment, changing the issuing country to obtain a CLV, for example because the manufacturing country does not issue one and the licence holder country does, affected only the form of the dossier. After the amendment, if the new issuing country has no mutual recognition relationship with Costa Rica, that act directly triggers the full completion obligation of Articles 11, 12 or 13. The completion point is set at the handling of renewal or post-registration change, that is, at exactly the moment when the company most needs continuity of its registration.

Insight 3: The completion tier follows the product class, not the number of documents that were waived. The provision states expressly that an IVD in Clase 2 completes under Article 11, Clase 3 under Article 12, and Clase 4 under Article 13. The meaning is that once triggered, what must be completed is the complete dossier for that class, not merely the few documents that were previously waived. For Clase 3 and 4 this means submitting the six clinical evidence items of Article 12.2 and the three additional items of Article 13.1, at a cost comparable to a first registration.

Insight 4: The discretionary right to demand completion at any time and the objective completion obligation upon a break are two mechanisms of different strength. The first paragraph grants the Ministry of Health a discretionary completion right, on technical and scientific grounds, exercisable even after registration. The second and third paragraphs create an objective completion obligation that arises as soon as the condition is met. What a company can manage is the second and third paragraphs: by tracking the status of recognition resolutions, controlling the CLV issuing country, and approaching changes of licence holder country and manufacturing country with care, the trigger can be avoided; the first paragraph can only be prepared for passively.

4. Practical recommendations

• Maintain a mutual recognition status ledger: record the equivalence recognition resolution on which each registration relies and track whether it has been revoked.
• Make the question of whether the CLV issuing country matches the recognised countries a mandatory pre-check for every renewal and change.
• Before switching the CLV issuing country, assess under the third paragraph of Article 17.3 whether full completion is triggered; if so, compare the cost of keeping the original issuing country against the cost of completing.
• Before changing the licence holder country or the manufacturing country, prepare for completion under the second paragraph of Article 17.3, and avoid handling it inside the renewal window.
• Pre-stage a completion package under Articles 11, 12 or 13, covering the BPM certificate, clinical evidence and post-market literature, so the response cycle shrinks from months to weeks.

5. Verification checklist

• □ Equivalence recognition resolution recorded for every registration
• □ CLV issuing country confirmed within the mutual recognition scope (17.3, third paragraph)
• □ Second paragraph completion obligation assessed before changing licence holder or manufacturing country
• □ Completion packages pre-staged by class under Articles 11, 12 or 13
• □ Renewal and change windows kept away from periods of movement in recognition status
• □ Monitoring mechanism established for revocation of recognition resolutions

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