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NEW QUESTION 41
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?

• A. Certificate of Analysis for the finished product
• B. Certificate of GMP
• C. Certificate of Pharmaceutical Product
• D. Certificate of Free Sale

Answer: C

NEW QUESTION 42
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

• A. Deficiency of a device found by the user prior to patient use
• B. Adverse event caused by patient conditions
• C. Malfunction occurring before the end of service life of the medical device
• D. Malfunction protection operated correctly

Answer: B

NEW QUESTION 43
Which of the following situations does NOT require rapid communication to regulatory authorities?

• A. A statistically significant increase in the number of deaths in an animal dose finding study
• B. A clinically important increase in the rate of occurrence of an "expected." but serious
  ADR
• C. A major safety finding from a newly completed animal carcinogenicity study
• D. A lack of efficacy with a medicinal product used in treating a life-threatening disease

Answer: B

NEW QUESTION 44
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

• A. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
• B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
• C. The manufacturer's experience level with the type of IVD medical device is limited.
• D. The device incorporates well-established technology that is already present in the market.

Answer: C

NEW QUESTION 45
......

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