What is the RAC certification and who should pursue it?

The RAC (Regulatory Affairs Certification) is a professional credential awarded by RAPS (Regulatory Affairs Professionals Society). It validates expertise in the regulatory requirements governing medical devices, pharmaceuticals, biologics, and diagnostics. The credential is ideal for regulatory affairs specialists, quality managers, clinical research professionals, and anyone whose role involves preparing or reviewing regulatory submissions in the US, EU, or Canada.

How hard is the RAC exam and what is the pass rate?

The RAC exam is widely regarded as one of the more challenging credentials in the life sciences sector. It consists of 150 scenario-based multiple-choice questions over three hours, requiring application of regulatory knowledge rather than simple recall. RAPS does not publish official pass rate statistics, but candidates typically report needing 3 to 6 months of focused preparation. The passing scaled score is 200 out of a possible 300.

What is the difference between RAC (US), RAC (EU), and RAC (Canada)?

RAPS offers region-specific RAC specializations. RAC (US) focuses on FDA regulations for drugs and devices. RAC (EU) emphasizes the EU MDR, IVDR, EMA centralized procedure, and CE marking. RAC (Canada) covers Health Canada pathways including Medical Device Licences and Drug Identification Numbers. Each specialization shares a common core of regulatory principles but tests region-specific submission requirements and regulatory bodies.

Can I download and print the RAC practice test PDF for study group use?

Yes, the PDF is free to download and share. It works as a standalone study resource or as a supplement to online practice. Many candidates print copies for peer review sessions, use the questions as flashcard prompts, or work through the PDF in timed paper drills. For the best results, pair it with our online RAC practice tests to get immediate feedback and track which regulatory domains need more attention.

RAC Regulatory Affairs Certification Practice Test PDF (Free Printable 2026)

Download a free RAC practice test PDF. Print and study offline for the RAPS Regulatory Affairs Certification examination for healthcare and pharmaceutical professionals.

RAC - Regulatory Affairs CertificationMay 4, 20264 min read

Free RAC Practice Test PDF Download

The RAC (Regulatory Affairs Certification) credential from RAPS (Regulatory Affairs Professionals Society) is the gold standard for professionals working in medical device, pharmaceutical, and biotechnology regulatory affairs. Passing the RAC exam demonstrates mastery of complex global regulatory frameworks — from FDA submission pathways to EU MDR compliance and ICH guidelines — making it one of the most valued credentials in the life sciences industry.

This free RAC practice test PDF gives you printable exam questions covering all major RAC exam domains. Download it to study on your commute, review during breaks, or run paper-based drills with colleagues. Each question reflects the style and difficulty level of the actual RAPS exam.

📄Download Free RAC PDF

RAC Exam Fast Facts

What the RAC Exam Covers

The RAC exam tests your ability to apply regulatory knowledge to real-world scenarios involving drugs, biologics, medical devices, and diagnostics. Questions are scenario-based and require understanding not just what regulations say, but how to apply them across different product types and geographic markets.

US Regulatory Pathways

A significant portion of the exam covers FDA processes: 510(k) clearance and substantial equivalence arguments for medical devices, Pre-Market Approval (PMA) for high-risk devices, De Novo classification requests, Biologics License Applications (BLA), New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA) for generic drugs. You must understand the evidentiary standards and documentation requirements for each pathway.

EU Regulatory Framework

Questions on the EU track cover CE marking requirements, the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), Notified Body roles, technical documentation requirements, and the European Medicines Agency (EMA) centralized procedure for drug authorizations.

ICH Guidelines

The International Council for Harmonisation (ICH) guidelines are heavily tested. You need command of the Q series (pharmaceutical quality), S series (nonclinical safety), E series (clinical efficacy and safety), and M series (multidisciplinary topics including eCTD format). Understanding how ICH guidelines are implemented differently across FDA and EMA is a key exam skill.

Clinical Trials and Post-Market Surveillance

This domain covers IND application requirements, Good Clinical Practice (GCP) standards, IRB/IEC oversight, 21 CFR Part 312 compliance, adverse event reporting timelines (MedWatch, MDR reports), and the distinction between expedited and periodic safety reports. Post-market surveillance planning for both drugs and devices is tested in depth.

Free RAC Practice Tests Online

Printable PDFs are ideal for offline study, but timed online practice sharpens your test-taking skills for exam day. Our RAC practice test covers all key regulatory domains with instant scoring and detailed answer explanations. Combining the PDF with online timed sets gives you the most complete preparation for this challenging three-hour certification exam.

Join the Discussion

Connect with other students preparing for this exam. Share tips, ask questions, and get advice from people who have been there.

View discussion (3 replies)