Regulatory Affairs Certification (RAC) Global Scope: RAC-GS

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A. Ask the vendor to take responsibility.

B. Document and perform audits.

C. Request an inspection from a regulatory authority.

D. Request documentation from the sub-contractor.

Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

A. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.

C. The manufacturer's experience level with the type of IVD medical device is limited.

D. The device incorporates well-established technology that is already present in the market.

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Safety and failure risk

B. Safety and effectiveness

C. Quality and failure risk

D. Quality and effectiveness