lo li pharma international s r l

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Build long-lasting business partnerships Lo.Li. Pharma International is the global subsidiary of Lo.Li. Pharma Group, an Italian leader in the research and development of scientifically validated health solutions. We operate through a dedicated B2B model, collaborating with a trusted network of local partners who choose to bring our products to their national markets. Thanks to […]

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Manufaktur FarmasiMesin IndustriPerlengkapan Medis & Kesehatan

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Jelajahi

Distributor di ItaliaManufaktur Farmasi di ItaliaMesin Industri di ItaliaPerlengkapan Medis & Kesehatan di Italia

Aturan yang berlaku untuk barang ini

Regulasi yang umum berlaku untuk pengiriman di sektor ini. Bukan nasihat hukum: periksa sumber resmi yang ditautkan.

• 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)
• Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission
• Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)