Архивы authorization - Национальный научный центр Фармаконадзора

2021-11-09T14:35:44+03:00

Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to finalize the documents.At the time of submitting an application for state authorization of a medicinal product to the Ministry of [...]

Kazakhstan has introduced the practice of inspection of medical devices prior to state registration

Елена Матвеева2021-11-08T17:20:17+03:00

Medical devices with a medium (e.g., sterile injectable medical devices), high (dental implants, stents), or very high (implantable pacemakers, absorbable suture material) potential risk of use are subject to inspection. The national regulatory agency inspects not only the functioning of the quality management system of medical devices but also evaluates the measures taken by the [...]

Composition of a registration dossier

Kazakhstan has introduced the practice of inspection of medical devices prior to state registration