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Updated: Sep 17, 2026
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What is the Prerequisite for taking the RAPS RAC-GS Certification Exam?
The candidates are required to have at least a bachelor's degree or equivalent and two years of relevant experience in the healthcare product sector. They are also needed to have at least one year of professional experience in Regulatory Affairs. Premarket approval required by the regulatory agency is also needed for those candidates who wish to take the RAC-GS Certification Exam.
RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope Exam |
| Exam Number: | RAC-GS |
| Exam Format: | Computer-Based, Recall, Application, Analysis, Multiple Choice |
| Certificate Validity Period: | 3 years |
| Exam Price: | $605 (RAPS Member), $760 (Non-Member) - 2026 rates |
| Exam Duration: | 210 minutes |
| Passing Score: | 70% |
| Available Languages: | English |
| Real Exam Qty: | 150-180 |
| Related Certifications: | RAC-Drugs RAC-Devices |
| Recommended Training: | RAPS Fundamentals Textbooks RAPS Online University |
| Exam Registration: | Pearson VUE Scheduling RAPS Official Application |
| Sample Questions: | RAPS RAC-GS Sample Questions |
| Exam Way: | Computer-based testing at Pearson VUE centers or online remote proctoring |
| Pre Condition: | Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended |
| Official Syllabus URL: | https://www.raps.org/certifications/rac |
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There are numerous resources like online free or paid courses, blogs, books, magazines, online tutorials that you can use for the prep of the RAPS RAC-GS Certification Exam. But the best source for the prep of the RAC-GS Certification Exam is practice exams of the Prep4King. These RAC-GS exam dumps contain queries that appear in the actual exams. This makes the practice more realistic and improves your performance.
RAPS RAC-GS Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Global Regulatory Environment & Strategy | 35% | - International Regulatory Frameworks
|
| Topic 2: Post-Market Compliance & Surveillance | 20% | - Labeling, Advertising & Changes
|
| Topic 3: Regulatory Submissions & Approval | 20% | - Global Dossiers & Submission Formats
|
| Topic 4: Product Development & Lifecycle Management | 25% | - Clinical Research & Trials
|
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