Question

Medical devices are notified as DRUGS under the Drugs & Cosmetics Act. Schedule for Medical devices GMP requirements is specified under:

• A. \( \text{Schedule M III} \)
• B. \( \text{Schedule M-II} \)
• C. \( \text{Schedule M-I} \)
• D. \( \text{Schedule M} \)

Hint:

Strict compliance with GMP regulations is essential for ensuring medical devices' efficacy and safety in clinical settings.

Answer 1

The Correct Option is A

In India, medical devices are regulated as drugs under the Drugs & Cosmetics Act. The GMP (Good Manufacturing Practices) requirements for medical devices are specifically outlined in Schedule M III of the Act. This regulation ensures that medical devices meet quality and safety standards for patient care.