Nov 4, 2019

The Indian government has set a deadline of December 1, 2019 for extending regulatory oversight to all medical devices not already requiring registration for sale in the country.

A recent notice from the Indian Ministry of Health and Family Welfare would establish compliance to the country’s Medical Devices Rules, 2017 as a requisite for medical device market entry. All devices, combination products and software intended for the following purposes will fall under oversight of the Indian Central Drugs Standard Control Organization (CDSCO):

  • Diagnosis, treatment, monitoring or prevention of any disease or disorder;
  • Diagnosis, treatment, monitoring or prevention of any injury or disability;
  • Examination, replacement, modification or support of patient anatomy or physiological process;
  • Supporting or sustaining life;
  • Device disinfection;
  • Conception/birth control

Stakeholders have a 30-day window whereby CDSCO will accept comments on the notification before finalization.

Following the Indian government’s reform of medical device market regulatory systems in 2017, the scope of CDSCO oversight has gradually expanded to cover more and more types of devices, most recently in early 2019. Emergo by UL consultants in New Delhi will monitor CDSCO’s progress implementing the new regulatory scope for more details and developments.

Additional Indian medical device regulatory resources from Emergo by UL: