South America Implants S.A.
Plant certified by the Brazilian health regulator (ANVISA)
ANVISA, the Brazilian health regulator, holds a valid Good Manufacturing Practice certificate for this plant, covering medical devices, valid until 2027-07-31. The certificate is issued after an inspection of the plant itself, which is why a foreign regulator names this site: goods made here are allowed on the Brazilian market. Process number 25351189915201342.
- Type
- Manufacturer
- Location
- Argentina
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
- Markets
- अर्जेंटीना, ब्राज़ील
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- tax-filing-active (green), checked 2026-08-15 ARCA (Argentine tax authority), full taxpayer status file (Constancia de inscripcion, RG 1817)
- registry-id-verified (green), checked 2026-08-21 Taxpayer status file (Constancia de inscripcion)
- registered-manufacturer (green), checked 2026-08-22 Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)