India medical device QA/RA blog

News and commentary on regulatory changes.

Indian Regulators Publish New Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

  • The Indian government has published new medical device and IVD regulations to replace the country’s Drugs and Cosmetics Act.
  • The new rules will go into effect January 1, 2018.

India Medical Device Rules, 2017 publishedIndia’s Ministry of Health and Family Welfare has released long-awaited new medical device and in vitro diagnostic (IVD) regulations that take effect in January 2018.

The Medical Device Rules, 2017, issued by the Ministry’s Central Drugs Standard Control Organization (CDSCO), will replace India’s longstanding Drugs and Cosmetics Act upon implementation.

Emergo consultants in New Delhi and Secunderabad are currently analyzing the new rules to determine how existing and prospective medical device registrations in India will be impacted. Stay tuned for additional updates.

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