Regulatory Authority (RA) definition
Regulatory Authority (RA) means a Government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements
Regulatory Authority (RA) means the FDA or the analogous regulatory body of any other country or territory where a Test is performed or sold.
Examples of Regulatory Authority (RA) in a sentence
Sponsor and/or CRO shall obtain approval from the Regulatory Authority (RA) and Ethics Committees (EC) per local law for the protocol identified above (“Protocol”) and the informed consent form before initiation of the Study.
All fees related to Ethics Committees (MEC and LEC) and Regulatory Authority (RA) are paid by PPD and/or Sponsor apart from this Agreement or Exhibit 1.
The Institution shall be responsible for ensuring submission of required expedited and periodic reports to the appropriate Regulatory Authority (RA), the Ethics Committee and investigators of each country participating in the ISS/ESC (based on applicable regulations).