India’s Ministry of Health and Family Welfare has finalized a new set of in vitro diagnostic (IVD) and medical device regulations, which will come into force on January 1, 2018.
The Medical Devices Rules, 2017
will replace the country’s current Drugs and Cosmetics Act.
Licenses obtained before the implementation date will remain valid until their expiry date or July 31, 2018, whichever is later. Until the new rules are introduced, licenses will continue to be issued for a three-year period and a separate import license for importers will still be required.
Under the new rules, the Central Drugs Standard Control Organization (CDSCO) will retain the right to conduct a quality management system (QMS) audit of a manufacturing facility anytime during or after the registration process. Audits will be mandatory for India-based manufacturers but mostly need-based for foreign manufacturers.
Domestic companies producing low risk devices will need to pass a quality system audit conducted by a dedicated Notified Body that is assigned by India's Ministry of Health and Family Welfare. Foreign companies will need to be ISO 13485 certified by an EU Notified Body. Contact us
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