Prior approval / evidence record
China NMPA approval: origin evidence only
- Statement
RTCR 505:2022 (Decreto Ejecutivo 43902-S) requires, for imported equipo y material biomédico, a Certificate of Free Sale as defined in numeral 4.7 (as amended by Decreto Ejecutivo 44431-S of 11 April 2024): a document issued by the competent authority of the country or region of origin certifying that the products are authorized for sale, use or distribution there, legalized or apostilled with official translation (numeral 11.3). For China-made devices an NMPA certificate is that document; it does not shorten the review.
- Source Jurisdiction Id
china
- Source Authority Id
nmpa
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
costa-rica
- China Classes In Scope
NMPA Class I filings and Class II/III certificates for EMB classes 2, 3 and 4 (class 1 exempt from registration)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
- Numeral 11.3: CLV legalized/apostilled with official Spanish translation and notarial certification per Decreto 37988-S
- Numeral 4.7 (reformed): where the product is not sold in the country of manufacture, the CLV may come from the authority of the product owner's country or of an affiliate's country within the same parent company
- Numeral 10.22: if the origin authority does not issue a required document, a letter citing the foreign rule is accepted
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Effective from 2023-09-09
Source passage: 4.7. Certificado de Libre Venta: Es el documento expedido por la autoridad competente del país o región de origen, en el cual se certifica que el producto o productos a que se refiere el certificado están autorizados para la venta, uso o distribución en el país o región de origen.
