Verification and Class Reassessment Power

1. Key takeaways

Yes, the power exists. Article 22 of the principal regulation establishes two powers: Article 22.1 — compliance with the registration approval and with the various provisions of the principal regulation is subject to state verification or control, carried out by the Ministry of Health or the inspectors it authorises for that purpose (inspectores); and Article 22.2 — where the Ministry of Health has reasonable grounds to believe that an EMB imported or commercialised as Clase 1 does not belong to that risk category under Annex A, it may require the product holder or its domestic legal representative to submit materials in order to determine the true classification of the EMB. This is a post-market reassessment power, and it is the symmetric constraint that accompanies the Clase 1 exemption.

• State verification under Article 22.1 may be performed by the Ministry of Health or by inspectors authorised by it, so the scope of who may appear on site is wider than ministry staff alone.
• Article 22.2 is the only provision dedicated specifically to reassessing Clase 1, and its trigger threshold is reasonable grounds (motivos razonables), not a proven error.
• Clase 1 is exempt from registration under Article 2.4, but the control (control) obligation continues to apply.
• A reassessment that reclassifies a product as Clase 2 or above can cascade into serious infringement liability, re-registration as a new product, and market withdrawal risk.
• Obstructing an inspection is an infringement at two levels of the approving decree, with blocking entry treated more severely than delaying or hindering.

2. Legal basis

The reassessment and verification powers are grounded in the technical regulation RTCR 505:2022 and are enforced through the infringement regime of the approving decree Decreto Ejecutivo N° 43902-S. The following provisions are the ones relied on throughout this volume.

3. Expert insights

Insight one: The phrase or the inspectors it authorises for that purpose in Article 22.1 extends verification authority to personnel outside the ministry payroll. The original wording is la realizará el Ministerio de Salud o los inspectores que para tales efectos autorice el Ministerio. The meaning is that the individuals who appear on site to conduct verification may be external inspectors authorised by the Ministry of Health, but the legal consequences of their inspection conduct attach to the Ministry. When receiving a verification visit, a company should verify the authorisation credential and keep a written record of the inspection, rather than looking only at a work badge.

Insight two: Article 22.2 is the single clause dedicated to reassessing Clase 1, and its trigger threshold is reasonable grounds (motivos razonables). The clause does not require the Ministry of Health to prove a classification error first; it needs only reasonable grounds to suspect that a product, under Annex A, does not belong in Clase 1, and it may then require the holder or its domestic legal representative to submit materials to determine the true classification. This is a low-threshold information demand power, and it is the direct reason companies must keep written justification for their classification decisions — the self-classification dossier recommended in volume 07 exists precisely to answer this clause.

Insight three: The outcome of a reassessment can cascade into three obligations at once. If the reassessment finds that the product is actually Clase 2 or above: first, the earlier sale without registration falls under Article 2 II.b) of the approving decree as a serious infringement; second, the product must be re-registered as a new product under Article 10.5 (with the dossier routes of Articles 11, 12 and 13); and third, market withdrawal and suspension of registration may further be triggered under the second paragraph of Article 3 of the approving decree. This cascade explains why classification determination must not be treated as a one-time exercise.

Insight four: Obstruction of inspection is defined as an infringement at two tiers. Article 2 I.b) of the approving decree lists hindering or delaying inspection work by any act or omission as a minor infringement, while Article 2 II.f) lists preventing inspectors who have been properly identified from entering manufacturing, storage, distribution or sales premises as a serious infringement. The difference lies in the form of conduct: delay and hindrance are minor, whereas blocking entry is serious. Companies preparing for verification should keep these two red lines clearly separated.

4. Practical recommendations

• Keep a written self-classification dossier for every product placed on the market as Clase 1 (the rule number applied, the determining elements and the conclusion), ready for an Article 22.2 demand.
• Prepare a verification response plan: verify the inspector’s authorisation documents, keep copies of inspection records, and inform the domestic legal representative within 24 hours.
• Keep the two red lines distinct: never delay or obstruct an inspection (Article 2 I.b), and never block inspectors from entering premises (Article 2 II.f).
• Obtain a pre-market determination for products whose classification sits near a boundary, to reduce the probability that a reassessment overturns it.
• If a reassessment is overturned, assess in the same breath the Article 10.5 re-registration route and the market withdrawal risk under Article 3 of the approving decree, and never continue selling in silence.

5. Verification checklist

• □ A written self-classification dossier has been established for Clase 1 products (Article 22.2)
• □ A verification response plan has been prepared, including verification of authorisation documents
• □ The two red lines of obstructing inspection and blocking entry have been distinguished (I.b and II.f)
• □ Products near classification boundaries have received a pre-market determination
• □ Re-registration and withdrawal responses are pre-positioned for an adverse reassessment outcome
• □ The definition of state control has been incorporated into the internal control manual (definition 4.11)

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