Sanctions withdrawal suspension and cancellation

1. Key takeaways

Article 3 of the approving decree establishes four tiers of consequences. First, where an infringement is committed or the declared information is untrue, the Ministry applies special health measures and sanctions under the Ley General de Salud. Second, where the conduct constitutes a serious infringement, the Ministry may require withdrawal from the market (retiro del mercado) together with suspension of the registration, and where the infringement cannot be remedied, cancellation of the registration. Third, where the conduct constitutes an extremely serious infringement, the registration is cancelled immediately. Fourth, whenever the Ministry becomes aware of any adverse event, harmful event or situation endangering public health, it may require withdrawal from the market as a precautionary and protective measure (medida cautelar y protectora). The provision binds administrative sanctions to product dispositions: what starts as a compliance failure can end as the loss of the product’s place on the market, and the last tier operates even before any infringement is formally established.

2. Legal basis

The provisions below assemble the four consequence tiers of Article 3 of the approving decree, the serious-infringement category that feeds them, and the substantive legal bases for sanctions and vigilance.

3. Expert insights

Insight 1: the second paragraph of Article 3 makes remediability the watershed between suspension and cancellation. The source text reads: el Ministerio podrá solicitar el retiro del mercado del EMB y la suspensión del registro y en caso de que la falta no pueda ser subsanada se procederá con la cancelación del registro sanitario. The meaning is that a serious infringement first triggers withdrawal plus suspension, giving the company a window to remedy; only if the infringement cannot be remedied does the registration get cancelled. This structure favours the company: responsiveness and remediation capability are themselves compliance assets. A company that can demonstrate rapid correction within the suspension window converts an existential threat into a recoverable event.

Insight 2: the immediate cancellation for extremely serious infringements has no remediation window. The third paragraph of Article 3 reads: En caso en que se demuestre una infracción categorizada como muy grave se procederá a la cancelación inmediata del registro sanitario. Read together with the two items of tier III in Article 2 — selling an EMB that endangers health or safety, and selling a counterfeit EMB — the consequence of these two kinds of conduct is the immediate loss of the registration. The final paragraph of Article 3 additionally preserves parallel criminal and administrative proceedings. For these two categories there is no procedural path back within the registration system itself, which is why they must be treated as absolute red lines in supply-chain governance.

Insight 3: the precautionary withdrawal of the fourth paragraph does not require an infringement to be established. The source text provides that the Ministry’s knowledge of any adverse event, harmful event or event that puts public health at risk allows it to require withdrawal from the market as a medida cautelar y protectora — a precautionary and protective measure. The meaning is that as soon as the Ministry becomes aware of an adverse event or public health risk, it may require withdrawal, without first determining that any infringement occurred. This is the most immediately exercisable power in the regulation, and it links directly to the company’s technovigilance obligation under Article 21: the information the company itself reports may trigger the withdrawal of its own product. Reporting quality and risk assessment therefore travel together.

Insight 4: the combination of Article 2, II.b) and the second paragraph of Article 3 means procedural omissions can escalate into product dispositions. Item II.b) lists failure to fulfil registration, renewal or post-registration change filing obligations directly as a serious infringement; the second paragraph of Article 3 provides that serious infringements may lead to market withdrawal and suspension of the registration. The meaning is that missing a renewal or a change filing — apparently administrative slips — can trigger the withdrawal of the product from the market. This is precisely why this volume keeps insisting on a unified expiry-date register across registration, renewal, powers of attorney, permits and contracts: the register is the primary defence against an escalation that begins as a calendar failure.

4. Practical recommendations

• Build an incident-response mechanism: as soon as conduct that may be characterised as an infringement emerges, assess first whether it can be remedied, and aim to complete correction within the suspension period.
• Bring the expiry dates of renewals, changes, powers of attorney, operating permits and manufacturing contracts into a single register, so that procedural omissions never escalate into serious infringements.
• Run technovigilance reporting and commercial risk assessment in parallel: before reporting an adverse event, assess the possibility of precautionary market withdrawal under the fourth paragraph of Article 3.
• Treat extremely serious infringements — safety hazards and counterfeiting — as single-veto items and screen for them upstream in supply-chain management.
• Pre-build a market-withdrawal procedure in the emergency plan: channel notification, stock quarantine, alternative supply and a designated official-communications owner.

5. Verification checklist

• □ Response mechanism built around the four consequence tiers of Article 3
• □ Serious-infringement items assessed for remediability with a defined correction path
• □ Extremely serious items placed on a single-veto list
• □ Expiry-date register covering renewals, changes, powers of attorney, permits and contracts
• □ Precautionary-withdrawal risk assessed alongside technovigilance reporting
• □ Market-withdrawal emergency plan pre-built with a designated owner

Related reading: [Three infringement tiers of 18 items and the four prohibitions](/costa-rica-medical-device-registration/infringements-three-tiers-and-four-prohibitions/) | [Technovigilance obligations: Article 21 and DE 39342-S](/costa-rica-medical-device-registration/tecnovigilancia-obligations-and-decree-39342/) | [Five-year registration validity and the eleven renewal items](/costa-rica-medical-device-registration/five-year-validity-and-renewal-eleven-items/)

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