CRAP Global Regulatory Requirements & Standards 3 — Questions and Answers
Question 1: Which regulation governs the post-market surveillance obligations for medical device manufacturers in the European Union?
- EU MDR 2017/745 (Correct answer)
- EU IVDR 2017/746
- Directive 93/42/EEC
- ISO 14971
Correct answer: EU MDR 2017/745
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?
- Use of blockchain technology
- Audit trails, system validation, and controlled access with user authentication (Correct answer)
- Submission to FDA for approval prior to use
- Encryption of all data at rest
Correct answer: Audit trails, system validation, and controlled access with user authentication
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?
- Bioequivalence studies
- Good Clinical Practice (GCP) (Correct answer)
- Nonclinical safety testing
- Pharmacovigilance reporting
Correct answer: Good Clinical Practice (GCP)
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?
- IND approval
- NDA approval (Correct answer)
- 510(k) clearance
- Pre-submission meeting
Correct answer: NDA approval
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?
- ISO 9001
- ISO 13485 (Correct answer)
- ICH Q10
- 21 CFR Part 820
Correct answer: ISO 13485
ISO 13485 specifies QMS requirements specific to the medical device industry and is recognized by regulators worldwide.
Question 6: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) primarily facilitates what regulatory activity?
- Harmonization of GMP standards and mutual acceptance of GMP inspections (Correct answer)
- Joint clinical trial approvals across member countries
- Unified drug pricing in participating nations
- Electronic common technical document submissions
Correct answer: Harmonization of GMP standards and mutual acceptance of GMP inspections
PIC/S works to harmonize GMP standards and foster mutual recognition of inspection outcomes among participating regulatory authorities.
Question 7: In Brazil, ANVISA's product registration pathway for 'novo' (new) medicines requires submission of which dossier format?
- CTD format adapted to ANVISA requirements via Datavisa (Correct answer)
- ACTD format
- NDA format only
- WHO PQ dossier
Correct answer: CTD format adapted to ANVISA requirements via Datavisa
Brazil's ANVISA uses an adapted CTD format submitted through its Datavisa electronic system for new drug product registrations.
CRAP Global Regulatory Requirements & Standards 3
Which regulation governs the post-market surveillance obligations for medical device manufacturers in the European Union?