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Frequently asked Questions
A regulatory certification under MDR 2017 for medical devices to ensure safety and quality for sale in India.
It ensures legal compliance, patient safety and market access for medical devices, per Drugs and Cosmetics Act, 1940.
All notified medical devices (Class A–D), including diagnostics, implants and surgical tools, per MDR 2017.
Manufacturers and importers of notified medical devices, per Rule 20 of MDR 2017.
Non-compliance may lead to fines or bans under Section 27 of the Drugs and Cosmetics Act, 1940.
30–60 days for Class A/B (non-regulatory), 90–120 days for Class C/D, depending on complexity, per CDSCO processes.
Mandatory for Class C/D and some Class A/B if novel; predicate device data may suffice, per Rule 21.
Yes, with an Authorized Indian Agent to liaise with CDSCO, per Rule 20 of MDR 2017.
DMF, PMF, ISO 13485 certificate, clinical data (if applicable) and labeling details, per CDSCO guidelines.
We provide end-to-end support, from classification to certification, ensuring compliance and speed.
Five years, renewable with compliance audits, per MDR 2017, Rule 29.
No, support for renewals or compliance is an optional paid service, billed separately.
