Five year validity and renewal eleven items

1. Key takeaways

Article 15 of the technical regulation provides that the sanitary registration of an EMB is valid for 5 years (cinco años), without prejudice to the cancellation or modification powers that Ley N° 5395 (the General Health Law) confers on the Ministry of Health. Article 16 provides that a renewal runs for the same period as the original registration — that is, a further 5 years — and lists 11 renewal items: the application form (16.1), the power of attorney (16.2), the third-party manufacturing contract (16.3), the sworn declaration that the product has not changed (16.4), the GMP/BPM certificate (16.5), the domestic manufacturer’s operating permit (16.6), the CLV for imported products (16.7), the labelling (16.8), the radiation source authorisation (16.9), the biosafety certificate for products of animal origin (16.10), and payment of the fee (16.11). The renewal must be filed before the registration expires by the product holder or its legal representative through Regístrelo.

2. Legal basis

The provisions below cover the validity period, the renewal materials and their conditional structure, and the statutory reservation of the Ministry’s cancellation and modification powers.

3. Expert insights

Insight 1: Article 15 places the five years and the cancellation power in the same sentence — validity is not a vested right. The source text reads: El registro de EMB tendrá una vigencia de cinco años, sin perjuicio de las facultades de cancelación o modificación que le otorga al Ministerio la Ley No. 5395. The meaning is that five years is the default duration of the registration, but the Ministry may cancel or modify it at any time under Ley 5395. Combined with Article 3 of the approving decree — under which serious infringements may lead to suspension and extremely serious infringements to immediate cancellation — the practical meaning of the validity period is that the registration endures for five years absent infringing conduct. Compliance performance, not the calendar alone, determines whether the full term is enjoyed.

Insight 2: the renewal materials use a conditional structure — nothing already on file needs to be resubmitted; only missing or expired items are replaced. Article 16.2 (power of attorney) and Article 16.3 (manufacturing contract) are both conditioned on the phrase en caso de que no conste en expediente o se encuentre vencido; Article 16.8 (labelling) applies cuando la misma no conste en el expediente. This design significantly reduces the duplicate workload of renewal, but it demands that the company know exactly what its dossier contains — which is also why Article 16.4 requires a sworn declaration that the product has not changed. The evidential economy of the renewal depends on dossier discipline maintained since the first registration.

Insight 3: the sworn declaration of Article 16.4 is the centrepiece renewal document, with strict requirements on who may sign it. The source text reads: Declaración jurada emitida por el fabricante o el titular del producto o su representante legal siempre y cuando el poder otorgue esa facultad — it is issued by the manufacturer, the product holder or the legal representative, but the legal representative may sign only if the power of attorney confers that specific power. Documents issued abroad must be legalised or apostilled, with an official translation and notarisation of the digital signature. This provision assigns the burden of proving that nothing has changed squarely to the company. A representative signing without the necessary poder clause produces a defective declaration.

Insight 4: Article 16.10 imposes three cumulative formal requirements on the biosafety certificate for products of animal origin. The source text requires the certificate to be duly apostilled or legalised, accompanied by notarial certification, and, if issued in a language other than Spanish, accompanied by the official translation. Legalisation or apostille, notarisation and translation stand side by side. This is the most demanding documentary item among the renewal materials, and lead times for chain-of-custody certificates from the exporting country should be built into the renewal schedule accordingly.

4. Practical recommendations

• Maintain a validity register: under Article 15, plan on a five-year cycle and start renewal preparation six months before expiry.
• Before renewal, audit the dossier: submit the power of attorney (16.2), manufacturing contract (16.3) and labelling (16.8) only if they are missing or expired.
• Have the Article 16.4 sworn declaration issued by a duly qualified signatory; where the legal representative signs, first confirm that the power of attorney includes that power.
• For products of animal origin, prepare the biosafety certificate under Article 16.10 and process the three layers — legalisation or apostille, notarial certification and official translation — item by item.
• Verify under Article 16.9 that the radiation source authorisation is updated and valid, and in parallel check every distributor’s authorisation (Article 10.12).

5. Verification checklist

• □ Five-year validity recorded under Article 15
• □ Renewal window planned in advance (filed before expiry)
• □ Status of power of attorney, contract and labelling in the dossier checked (16.2 / 16.3 / 16.8)
• □ Sworn declaration issued by a qualified signatory (Article 16.4)
• □ GMP/BPM certificate assessed against Transitorio I (Article 16.5)
• □ CLV and operating permit verified under 16.6 / 16.7
• □ Radiation source authorisation and animal-origin certificate handled under 16.9 / 16.10
• □ Fee paid (Article 16.11)

Related reading: [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/) | [Statutory requirements for the poder and requirements for execution abroad](/costa-rica-medical-device-registration/power-of-attorney-requirements-for-emb/) | [The sanctions ladder: market withdrawal, suspension and immediate cancellation](/costa-rica-medical-device-registration/sanctions-withdrawal-suspension-and-cancellation/)

Regulatory information verified as of October 29, 2026.

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