FDA and CE Certificate Scope: Mandatory Only by Country of Origin

1. Key takeaways

Nicaragua applies an origin-based rule to the FDA and CE certificates: the FDA certificate is mandatory only for products manufactured in the United States (Chapter 6, item 7, closing sentence: La obligatoriedad del Certificado FDA es aplicable solo a productos fabricados en Estados Unidos), and the CE certificate is mandatory only for European Union manufacturers (item 9: Aplicado obligatoriamente a fabricantes de la Unión Europea). Both require an original or a notarially certified copy, Spanish or a notarially certified translation, and an apostille or consular legalisation.

• The test is where the product is made, not whether a certificate happens to exist in the company’s files.
• The two conditions sit in different items of Chapter 6: the FDA rule at the end of item 7, the CE rule in item 9.
• The CE rule looks at the manufacturer’s location, while the FDA rule looks at the country of manufacture; they are not drafted identically.
• Both certificates follow the same three-layer legalisation chain as the CLV.
• Neither certificate determines the Nicaraguan risk classification, which ANRS sets itself under Annex B.

2. Legal basis

The table sets out the two origin rules together with the related provisions on legalisation of the ISO 13485 certificate, on classification and on renewal, so that the scope of each certificate can be read against its actual wording.

3. Expert insights

Insight 1: the test is origin, not whether a certificate exists. A product manufactured in the United States must submit an FDA certificate even if it already holds a CE certificate, and an EU manufacturer must submit a CE certificate even if it already holds an FDA certificate. For products from neither the United States nor the European Union, the text does not require either category.

Insight 2: the two mandatory rules are written in different items. The FDA rule appears in the closing sentence of item 7, the CLV item, while the CE rule appears in item 9. Readers easily find only one of them, which is an example of provisions dispersed within a single chapter and a common reason for companies concluding, wrongly, that both certificates are required or that neither is.

Insight 3: the two rules are not drafted in identical terms. The CE rule refers to fabricantes de la Unión Europea, the location of the manufacturer, while the FDA rule refers to productos fabricados en Estados Unidos, the country where the product is made. Multinational groups must therefore assess each legal entity and each actual manufacturing site separately, rather than applying the group’s headquarters location across the board.

Insight 4: the legalisation requirements match those for the CLV: an original or notarially certified copy, Spanish or a notarially certified translation, and an apostille or consular legalisation. The chains for the CLV, the CE certificate and the ISO 13485 certificate share the same structure, so they can be processed together in one pass.

Insight 5: these certificates are admission evidence, not a basis for classification. Article 3 of Chapter 5 states clearly that ANRS classifies devices itself under Annex B, independently of classifications registered elsewhere. Submitting an FDA or CE certificate does not alter Nicaragua’s own risk classification, a point that is frequently confused when the dossier checklist is planned.

Insight 6: the certificates are also required at renewal. Article 1(e) of Chapter 8 lists the CE certificate among the renewal documents. Certificate expiry and registration expiry are two independent dates and must be monitored separately; otherwise a renewal can arise with a certificate that has lapsed while the registration is still in force.

4. Practical recommendations

• Assess the requirement against the actual country of manufacture and the manufacturer’s location: US manufacture calls for the FDA certificate, an EU manufacturer calls for the CE certificate, and neither origin calls for neither.
• Put a comparison table of the two rules into the internal SOP, so that the reading “both are required” or “neither is required” does not take hold.
• For multinational groups, decide by legal entity and manufacturing site, not by the location of group headquarters.
• Process the legalisation chains for the CLV, CE and ISO 13485 certificates together, to avoid repeated notarisation.
• Manage the FDA and CE certificates as admission evidence, kept separate from the classification conclusion, so that they are not misread as a basis for classification.
• Maintain two expiry tables, one for certificates and one for registrations, and replace certificates before renewal is filed.

5. Verification checklist

• □ The mandatory status of the FDA and CE certificates has been assessed against the actual origin and the manufacturer’s location
• □ The internal SOP contains a comparison table of the two rules
• □ Multinational groups have been assessed by legal entity and manufacturing site, not by headquarters location
• □ The legalisation chains for the CLV, CE and ISO 13485 certificates have been processed in one pass
• □ The FDA and CE certificates are managed as admission evidence, kept separate from the classification conclusion
• □ Two expiry tables exist, for certificates and for registrations, and certificates are replaced before renewal

Related reading: [ISO 13485 and MDSAP: the waiver of six monograph items](/nicaragua-medical-device-registration/iso-13485-and-mdsap-exemption/) | [Electrical safety certificate: IEC, UL, CSA or equivalent](/nicaragua-medical-device-registration/electrical-safety-certificate/) | [ANRS classifies devices itself, independently of other countries](/nicaragua-medical-device-registration/anrs-sets-risk-class-itself/)

Regulatory information verified as of 29 October 2026.

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, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com