RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS Exam Practice Test
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X.
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
Correct Answer: C,D
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At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
Correct Answer: D
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According to WHO,what are the temperature and humidity conditions for a Zone IVb long-term stability study?
Correct Answer: A
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A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
Correct Answer: D
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A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
What action should the regulatory affairs professional take FIRST?
Correct Answer: B
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A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?
Correct Answer: A
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Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
Correct Answer: C
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According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
Correct Answer: A
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Which of the following statements regarding the off-label use of drugs is CORRECT?
Correct Answer: A
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The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
Correct Answer: D
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