Mercury-Containing Medical Devices Ban

1. Key takeaways

From the date of entry into force of NTON 24001:2023, Nicaragua prohibits the manufacture, import, distribution and commercialisation of any medical device that contains or operates using added mercury (mercurio añadido). The provision lists mercury-containing dental amalgam, mercury-column blood pressure gauges, mercury thermometers, and surgical antiseptics or antibacterials containing added mercury, and closes with a catch-all covering parts and components. Dental amalgam carries one narrow transitional arrangement: public and private healthcare service providers holding stock on the date of entry into force may exhaust it over a maximum of 5 years, but must notify the DDM of the quantities in advance.

2. Legal basis

The table below lists the prohibition provision, its transitional note, the treaty that underpins it, and the entry-into-force and repeal provisions of the standard.

3. Expert insights

Point 1: The object of the ban is added mercury (mercurio añadido), not trace residues. The operative wording is que contenga o utilice mercurio añadido para su funcionamiento, containing or using added mercury for its operation. Trace impurities do not fall within the ban, but the provision sets no quantitative threshold, and the determination in practice rests on the composition declaration of the manufacturer.

Point 2: The list is open-ended. The provision introduces its four examples with tal es como, such as, and closes with partes y componentes de dispositivos médicos, sweeping parts and components into the ban as well. A product cannot be presumed compliant merely because it is not among the four examples; the catch-all is the key to the scope.

Point 3: The class of entities entitled to the 5-year exhaustion period is narrow. The NOTE reads los establecimientos proveedores de servicio de salud públicos y privados que cuenten con inventario, meaning public and private healthcare service providers holding inventory. The inventory of importers and distributors is not covered by this transitional arrangement, and the 5-year period cannot be invoked by them.

Point 4: The exhaustion period carries an independent obligation: deben notificar previamente a la Dirección de Dispositivos Médicos las cantidades en existencia, the existing quantities must be notified to the DDM in advance. The notification is a precondition of the exhaustion period, and failure to notify does not create an automatic exemption. The obligation rests on the healthcare institution side, not on the manufacturer or the distributor.

Point 5: The entry-into-force calculation is given by Chapter 16: 90 days after publication in the official gazette La Gaceta (en noventa (90) días, luego de su publicación en el Diario Oficial La Gaceta). The publication carrier verified in this volume is La Gaceta No. 192 (2024-10-21). The specific calendar date of entry into force is a matter for the official publication, and this volume does not calculate it on their behalf.

Point 6: No separate text of the DDM withdrawal procedure was obtained within the scope verified by this volume. Chapter 5 Article 13 uses the word emitirá, will issue, which places the procedure in a pending state. Companies should not assume that a mature process already exists, nor that products already imported may continue to be sold until their stock is exhausted.

4. Practical recommendations

• Move the mercury screening forward to the selection stage: what is checked is added mercury rather than total mercury content, and a written composition declaration should be obtained from the manufacturer.
• Screen parts and components together with the finished product: the catch-all brings parts and componentes within the ban, so a finished device that contains no mercury is not by itself compliant.
• Healthcare institution clients must perform the obligation under the NOTE to notify the DDM of the inventory quantities in advance, and keep the acknowledgment as the basis for the start of the 5-year exhaustion period.
• Distributor and importer inventory does not qualify for the 5-year transitional arrangement and must be treated under the ban; the notification by a healthcare institution client does not cover the distributor or importer stock.
• Until the withdrawal procedure is issued, the disposition of products already imported should be confirmed with the DDM in writing; do not decide on continued sale or return unilaterally.
• Keep a tracking record for Adenda 2026-05 against Chapter 5 Article 13, to confirm whether the scope of the ban and the transitional arrangement are adjusted.

5. Verification checklist

• □ The added-mercury screening of products and components has been completed, and the written composition declaration from the manufacturer obtained
• □ It has been checked whether the product falls within the four examples of Chapter 5 Article 13 or the catch-all for parts and components
• □ Healthcare institution clients have performed the obligation under the NOTE to notify the DDM of inventory quantities in advance, and the acknowledgments are retained
• □ It has been confirmed that distributor and importer inventory does not qualify for the 5-year exhaustion period
• □ The actual entry-into-force status of the standard has been checked against the 90-day rule of Chapter 16
• □ A publication tracker for the DDM withdrawal procedure has been set up, and no assumption has been made that imported products may continue to be sold

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan market. Our team manages Ministry of Health (MINSA) sanitary registration applications through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com