CRAP Global Regulatory Requirements & Standards 3

Question 1

Which regulation governs the post-market surveillance obligations for medical device manufacturers in the European Union?

Accepted Answer

EU MDR 2017/745

Answer

EU MDR 2017/745 establishes comprehensive post-market surveillance requirements for medical device manufacturers operating in the EU.

Question 2

Under 21 CFR Part 11, what is required for electronic records to be considered equivalent to paper records?

Accepted Answer

Audit trails, system validation, and controlled access with user authentication

Answer

21 CFR Part 11 requires audit trails, system validation, and access controls with unique user IDs and passwords for electronic records to be considered reliable equivalents to paper records.

Question 3

ICH E6(R2) and the emerging E6(R3) guidelines cover which regulatory domain?

Accepted Answer

Good Clinical Practice (GCP)

Answer

ICH E6 provides the GCP guidelines that define the responsibilities and standards for conducting clinical trials.

Question 4

Health Canada's Notice of Compliance (NOC) is equivalent to which US regulatory action?

Accepted Answer

NDA approval

Answer

An NOC from Health Canada grants market authorization for a new drug, equivalent to FDA approval of an NDA.

Question 5

Which global standard defines requirements for Quality Management Systems in medical device manufacturing?

Accepted Answer

ISO 13485

Answer

ISO 13485 specifies QMS requirements specific to the medical device industry and is recognized by regulators worldwide.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Global Regulatory Requirements & Standards 3