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FDA 510k Certification

Post Approval Changes

For major changes the license holder must obtain prior approval and for any minor change as specified in Sixth Schedule of India MDR, a notification to State or Central licensing authority required.

Medical Device QMS

The manufacturing site must comply with the requirements of quality management system as specified under Fifth Schedule of India MDR, which is required to produce medical devices of same quality.

Indian Agent

An authorized agent should act as the official representative for obtaining import licence in India and submit all necessary documents, as defined in the Fourth Schedule, for the import licence of medical device.

Technical Consultants

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Document Control

ISO 27001:2013 Certified data security system. NDA with team members.

Annual Maintenance

Technical files updated throughout the year by our team.

India Medical Device Regulation

Classification of Non Notified Devices

Guidance issued by Government of India on 3rd Sep 2020 regarding Device Classification of Non Notified Devices.

Regulatory Strategy

Refer I3CGlobal (IN) Website for more information.

Test license

Refer I3CGlobal (IN) Website for more Information.

Import License

Refer I3CGlobal (IN) Website for more details.

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