Czech Senate approves amendment to Medical Devices Act
2010-06-02
The Czech Senate has adopted an amendment to the Medical Devics Act. The amendment, which represents the implementation of an EU directive into Czech legislation, establishes stricter rules for the use of medical devices, redefines some of the new devices used in healthcare and establishes rules for clinical trials. It transfers some responsibilities pertaining to
clinical trials from the Health Ministry to the State Institute for Drug Control (SUKL).
The amendment has yet to be signed by the president.