RAPS Practice Test (New 2026/ 2027
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A device company has several CE-marked devices for a surgical procedure. The
company intends to market the devices as a system or a procedure pack as quickly as
possible. What is the most appropriate action for the regulatory professional to take?
A. No action needed as all devices are CE-Marked individually
B. Prepare new technical file for system or procedure pack
C. Prepare new labelling for device system or procedure pack
D. Verify mutual compatibility of these devices, adequate labelling and draw up a
declaration for the intended device system or procedure pack - Correct answer D.
Verify mutual compatibility of these devices, adequate labelling and draw up a
declaration for the intended device system or procedure pack
Following the introduction of a new regulation, an evaluation of the company's
products by the regulatory affairs professional indicates that 60 percent do not comply
with the regulation. What should the regulatory affairs professional do FIRST to meet
the new requirement?
,A. Contact the trade association for advice.
B. Communicate with the relevant internal departments.
C. Prepare documents for the files.
D. Request a permanent waiver from the new regulation. - Correct answer B.
Communicate with the relevant internal departments.
In addition to protection, what parameters MUST be considered when selecting the
primary package (or a product)?
A. Volume and material
B. Compatibility and safety
C. Safety and efficacy
D. Efficacy and material - Correct answer B. Compatibility and safety
A protocol for a pivotal registration trial of a new product is submitted to a major
regulatory authority for review and approval. The regulatory authority issues the
company a written commitment that if the studies are completed as outlined in the
protocol and the results meet the pre-specified criteria for efficacy and safety, the
product will be approved. During the final week of the review of the marketing
,application, which has fully met all pre- specified criteria, the company receives a
letter from the regulatory authority stating that it no longer believes that the product
will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
A. Notify the regulatory authority regarding its obligation to honor the commitment to
approve the application.
B. Consult with legal department to discuss best course of action.
C. Review the regulatory guidelines to determine - Correct answer D. Request meeting
with regulatory authority to discuss application
Which statement regarding export regulations for an approved product is CORRECT?
A. Product must not be in accord with foreign purchaser specifications.
B. Product must not conflict with country laws to which it is intended for export.
C. Product must not be labeled for export on outside of shipping package.
D. Product must not be sold or offered for sale in domestic commerce. - Correct
answer B. Product must not conflict with country laws to which it is intended for
export.
, In a distribution contract for high-risk devices, which regulatory requirement is the
MOST important for the distributor?
A. Local reimbursement requirements
B. Service operation procedures
C. Training program for sales people
D. Written procedure for product traceability - Correct answer C. Training program for
sales people
A company is considering developing a device similar to those already available. Which
of the following should be evaluated FIRST when developing a clinical evaluation
document?
A. Adverse event reports
B. Clinical experience
C. Clinical investigations
D. Literature search - Correct answer C. Clinical investigations
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A device company has several CE-marked devices for a surgical procedure. The
company intends to market the devices as a system or a procedure pack as quickly as
possible. What is the most appropriate action for the regulatory professional to take?
A. No action needed as all devices are CE-Marked individually
B. Prepare new technical file for system or procedure pack
C. Prepare new labelling for device system or procedure pack
D. Verify mutual compatibility of these devices, adequate labelling and draw up a
declaration for the intended device system or procedure pack - Correct answer D.
Verify mutual compatibility of these devices, adequate labelling and draw up a
declaration for the intended device system or procedure pack
Following the introduction of a new regulation, an evaluation of the company's
products by the regulatory affairs professional indicates that 60 percent do not comply
with the regulation. What should the regulatory affairs professional do FIRST to meet
the new requirement?
,A. Contact the trade association for advice.
B. Communicate with the relevant internal departments.
C. Prepare documents for the files.
D. Request a permanent waiver from the new regulation. - Correct answer B.
Communicate with the relevant internal departments.
In addition to protection, what parameters MUST be considered when selecting the
primary package (or a product)?
A. Volume and material
B. Compatibility and safety
C. Safety and efficacy
D. Efficacy and material - Correct answer B. Compatibility and safety
A protocol for a pivotal registration trial of a new product is submitted to a major
regulatory authority for review and approval. The regulatory authority issues the
company a written commitment that if the studies are completed as outlined in the
protocol and the results meet the pre-specified criteria for efficacy and safety, the
product will be approved. During the final week of the review of the marketing
,application, which has fully met all pre- specified criteria, the company receives a
letter from the regulatory authority stating that it no longer believes that the product
will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
A. Notify the regulatory authority regarding its obligation to honor the commitment to
approve the application.
B. Consult with legal department to discuss best course of action.
C. Review the regulatory guidelines to determine - Correct answer D. Request meeting
with regulatory authority to discuss application
Which statement regarding export regulations for an approved product is CORRECT?
A. Product must not be in accord with foreign purchaser specifications.
B. Product must not conflict with country laws to which it is intended for export.
C. Product must not be labeled for export on outside of shipping package.
D. Product must not be sold or offered for sale in domestic commerce. - Correct
answer B. Product must not conflict with country laws to which it is intended for
export.
, In a distribution contract for high-risk devices, which regulatory requirement is the
MOST important for the distributor?
A. Local reimbursement requirements
B. Service operation procedures
C. Training program for sales people
D. Written procedure for product traceability - Correct answer C. Training program for
sales people
A company is considering developing a device similar to those already available. Which
of the following should be evaluated FIRST when developing a clinical evaluation
document?
A. Adverse event reports
B. Clinical experience
C. Clinical investigations
D. Literature search - Correct answer C. Clinical investigations
