Pt Rohto Laboratories Indonesia
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 2027-09-04. 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 25351204177201744.
- Type
- brand seeking distribution
- Location
- Indonesia
- Categories
- Artykuły medyczne i związane z opieką zdrowotną
- Markets
- Indonezja, Brazylia
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)
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
- debarment-clear (green), checked 2026-09-02 OpenSanctions
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)