In late January, 2017, India’s Central Drugs Standard Control Organization (CDSCO) finally released Medical Device Rules, which establish different regulatory norms for medical devices and drugs. For over 10 years, the Indian government has been trying to set up new medical device registration requirements that are separate from drug registration requirements. The CDSCO aims to assist companies conducting business in India and improve patient care by making medical devices more accessible and affordable. The new regulations are expected to come into effect on January 1, 2018. Some significant changes include:
- Product licenses will no longer need to be renewed. All licenses will be valid unless suspended, surrendered, or cancelled.
- The entire medical device process (from application to grant of license) will be processed online.
- High risk medical devices no longer need a four-phase clinical trial in order to receive an import or manufacturing license. A two-phase clinical trial is still required. The first phase is a small-scale pilot study and the second phase is a larger-scale pivotal clinical trial.