MEDICAL DEVICES FOR MANUFACTURER
We Offer Prompt and Specialized Regulatory and Quality support to help secure CDSCO/State FDA Licenses for Medical Devices and IVDs, ensuring full compliance with India’s Standards/MDR 2017. Manufacturers seeking to produce Class A and Class B medical devices/IVDs will apply to and be granted licenses by the State Licensing Authority/SLA. Meanwhile, manufacturers intending to produce Class C and Class D medical devices/IVDs will have their applications reviewed and licenses granted by the Central Licensing Approving Authority/CLAA.
CDSCO-HQ/CLAA CDSCO-HQ/CLAA | STATE FDA/SLA | |
|---|---|---|
MD 9 | WHOLESALE LICENSE/MD 42 | |
MD 10 | MD 5 | |
MD 23 | MD 6 | |
MD 27 | ||
MD 13 | ||
MD 25 | ||
MD 29 | ||
PSUR |
MEDICAL DEVICES FOR IMPORTER
We offer swift and expert regulatory and quality support to help secure import licenses for medical devices/IVDs, ensuring complete compliance with MDR 2017. Importers of Class A, B, C, and D medical devices will have their applications reviewed and licenses issued by the Central Licensing Approving Authority (CLAA).
CDSCO-HQ/CLAA CDSCO-HQ/CLAA | STATE FDA | |
|---|---|---|
MD 15 | WHOLESALE LICENSE/MD 42 | |
MD 17 |
| |
MD 23 | ||
MD 27 | ||
MD 25 | ||
MD 29 | ||
PSUR |