Application for consultation on certification and registration of medical devices

medical device manufacturer

Foreign

Domestic

Type of medical device

Active - works from a power (or from batteries)

Sterile medical device

Invasive - injected into the human body

Implantable in the human body

Software

In Vitro diagnostics

Other

What certificates does the manufacturer have?

CE

Declaration of Confirmity

ISO 13485

ISO 9001