ANVISAAgência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
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We are excited to be working with GI Dynamics and look forward to leading the commercialization of EndoBarrier Therapy following ANVISA approval," said Melchiades da Cunha Neto, co-founder of SciTech.
Medical device registration according to ANVISA requirements begins with the classification of a product.
Segundo a ANVISA (2004), o certificado de Acreditacao esta escalonado em tres niveis: simples (nivel 1), pleno (nivel 2) e de excelencia (nivel 3).
All Alcard's products and equipments are approved by ANVISA, the Brazilian national health surveillance agency.
Brazil's ANVISA (Agenda Nacional deVigilancia Sanitaria) regulates pharmaceuticals and therapeutic goods for the country.
You now have access to: 4540 CTD dossiers, 451 ANVISA & 196 ANDA's, plus over 3500 older dossiers.
Accutest is the market leader amongst independent CROs, with the highest quality standards, quick turnaround time and a strong regulatory track record of 80+ accreditations/ approvals from global regulatory agencies like USFDA, WHO, ANVISA, EMA, DCGI, MCC, MOH-Turkey, NPCB-Malaysia and many more.
Of its strong regulatory track record of 80+ accreditations/approvals from global regulatory agencies, 12 are from ANVISA, the regulatory body that oversees the registration, production and sale of drugs in Brazil.
The two sites consisting of the Zwickau site, which produces bulk pharmaceutical tablets, capsules and controlled release products; and the Monheim site, which includes logistics and distribution centers, have bagged successful inspections from Brazil's ANVISA and the German Health Agency.
There has been a great deal of effort by ANVISA to unify regulations through the South American common market, called Mercosur.
In a tightly regulated environment, the company's manufacturing facilities have approvals from all the main regulators including US FDA, UKMHRA, WHO, MCC, ANVISA, and PMDA which means the company provides one universal standard both domestically and internationally.