(Video) Rajya Sabha TV (RSTV) The Big Picture: Medical Devices Under Drugs Law

Topic: Medical Devices Under Drugs Law

Guest:

S. Eswara Reddy, (Joint Drugs Controller General)
Ravi Valia, (Head, Government Affairs, B. Braun Medical)
Sangram Patnaik, (Corporate Lawyer)

Topic Description:

To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry on Tuesday notified medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices. The aim is to regulate all medical devices so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products. Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). At present, only 23 categories of medical devices are regulated under the law.