MCQ
Medical Device Regulatory Reform MCQ - Practice Questions with Answers
Solve 1 Medical Device Regulatory Reform questions for RAS/RPSC preparation.
Practice questions
Q1Consider the following statements regarding the 2026 amendments to the Medical Devices Rules, 2017: 1. Under the revised Rule 44, manufacturers using outsourced sterilisation facilities must still obtain a separate loan licence under Rule 25 even if the sterilising institution holds a valid licence. 2. Before this amendment, the European Union was already among the recognised jurisdictions for exemption from clinical investigation requirements, along with the United States and Japan. Which of the statements given above is/are correct?
Explanation
Statement 1 is incorrect: revised Rule 44 removes the need for a separate loan licence under Rule 25 when the sterilising institution holds a valid licence. Statement 2 is incorrect: recognised jurisdictions were the United States, the United Kingdom, Australia, Canada and Japan; the European Union is being newly included under Rule 63. Hence neither statement is correct.
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