BPM Certificate and the Transitorio I Deferral of Its Mandatory Force

1. Key takeaways

Article 11.5 of the main regulation requires the manufacturer’s Good Manufacturing Practices certificate (Certificado de Buenas Prácticas de Manufactura, BPM), covering all sites that participate in one or more stages of the product life cycle. However, Transitorio I of the approving decree provides expressly that, until national BPM regulations for EMBs are issued, the BPM certificates required by Articles 11.5, 16.5, 18.9.2, 18.11.1 and 18.16.3 are not mandatory (no será exigido); at the same time, Transitorio IV requires the Ministry of Health to issue those regulations within 12 months of the regulation’s entry into force. In other words, the mandatory force of the BPM certificate is in a statutory state of suspension, and the condition for lifting the suspension is the Ministry’s issuance of the BPM regulations for EMBs.

• What Transitorio I suspends is the certificate obligation, not BPM compliance itself.
• The suspension is anchored to the issuance of national BPM regulations, not to a fixed date.
• Transitorio IV sets the Ministry a 12-month rulemaking deadline, but its expiry neither creates the regulation nor restores the certificate obligation automatically.
• Five provisions are suspended at once: initial registration, renewal, and three change scenarios — the deferral is systemic.
• Article 11.8.2 still requires the third-party manufacturing contract to contain the commitment to comply with BPM.

2. Legal basis

The suspension mechanism rests on the two transitional provisions of the approving decree and reaches five articles of RTCR 505:2022, as summarised below.

3. Expert insights

Insight 1. Transitorio I suspends the obligation to hold a certificate, not the obligation of BPM compliance itself. What the provision exempts is the duty to submit the certificate of Article 11.5. Meanwhile, Article 11.8.2 requires the third-party manufacturing contract to contain the commitment to comply with the Good Manufacturing Practices (Compromiso de cumplimiento de las Buenas Prácticas de Manufactura), and Article 6 requires the holder to ensure that the product meets the safety and performance requirements and to hold objective evidence available to the authority on request. The meaning is that not submitting the certificate does not mean BPM need not be met — only that the certificate is not required as the form of proof.

Insight 2. The time anchor of the suspension is the issuance of national BPM regulations, not a fixed date. Transitorio I uses the wording hasta que a nivel nacional se cuente con un Reglamento de Buenas Prácticas de Manufactura para EMB — until national BPM regulations for EMBs exist. This is a condition-triggered suspension with no expiry date. Transitorio IV sets the Ministry a 12-month rulemaking deadline, but the expiry of that deadline neither automatically produces the regulation nor automatically restores the certificate obligation. Companies should schedule on the assumption that the obligation may be restored at any time.

Insight 3. Article 11.5’s coverage requirement for the certificate is written more broadly than is commonly assumed. The text requires the certificate to include the sites participating in one or more stages of the product life cycle, expressly listing design and development, production, storage and distribution, installation or technical support, and design development or related activities. The meaning is that a certificate covering only the production site may not, on a strict reading, satisfy the requirement; a certificate covering multi-stage sites is the safer position. This will become a substantive review point once the suspension is lifted.

Insight 4. Five provisions are suspended simultaneously, which shows that the suspension of the BPM obligation is systemic, not confined to initial registration. The suspended provisions cover initial registration (11.5), renewal (16.5), change of manufacturer (18.9.2), change of manufacturing site (18.11.1) and change of holder and manufacturer (18.16.3). This list covers every scenario in which the certificate could be demanded, and prevents the inconsistency of a certificate not required at registration but demanded at a change filing.

4. Practical recommendations

• Assess under Transitorio I whether a BPM certificate is currently required, and state in the dossier the transitional provision relied on.
• Track in parallel whether the Ministry of Health has issued the BPM regulations for EMBs; once issued, immediately resume preparing the Article 11.5 certificate.
• Even without submitting the certificate, the third-party manufacturing contract must still contain the commitment to comply with BPM (Article 11.8.2).
• Hold objective evidence available to the authority on request under Article 6 (quality system certificates, audit reports and similar), ready for any restoration of the requirement.
• Obtain in advance a BPM certificate covering multi-stage sites, to avoid schedule delays from rushed evidence-gathering once the regulations are issued.

5. Verification checklist

• □ Confirmed under Transitorio I whether the BPM certificate is currently mandatory
• □ Transitional provision relied on is stated in the dossier
• □ Third-party manufacturing contract contains the BPM compliance commitment (11.8.2)
• □ Objective evidence available to the authority is held under Article 6
• □ Monitoring of the Ministry’s BPM regulations issuance is in place
• □ Certificate coverage scope pre-assessed (multi-stage sites, 11.5)

Related reading: [Seven mandatory items of the third-party manufacturing contract](/costa-rica-medical-device-registration/third-party-manufacturing-contract-seven-items/) | [Regulatory timeline 2022 to 2026 and the four transitional provisions](/costa-rica-medical-device-registration/costa-rica-regulatory-timeline-2022-2026/) | [Three-tier alternative evidence when the CLV lacks product codes](/costa-rica-medical-device-registration/clv-without-product-codes-alternative-evidence/)

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