How Long Does Medical Device Import License Take?

The approval timeline for a medical device import license in India depends on the device classification under the Medical Device Rules, 2017.

For Class A and Class B devices (low to low-moderate risk), the approval process generally takes 3 to 6 months, provided that documentation is complete and no major regulatory queries arise.

For Class C and Class D devices (moderate to high risk), the review process typically takes 6 to 9 months, as CDSCO conducts a more detailed technical evaluation.

However, timelines may extend due to:
Incorrect device classification
Incomplete Device Master File or Plant Master File
Labeling non-compliance
Delayed responses to CDSCO queries

Importers and foreign manufacturers often reduce approval delays by ensuring accurate documentation and proactive query management. CDSCO Consultant like Regacats Solutions helps Importer and foreign manufacturers to get timely approval
If you require assistance with MD14 filing, documentation review, or authorized agent appointment, you may explore our medical device import license consultancy services in India for end-to-end regulatory support.