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Bringing a first-of-its-kind device to India? Medfins provides strategic guidance and complete support to help you secure CDSCO approval under the MD-27 pathway for non-predicate devices.
Visual timeline or steps:
| Applicant Type | Application | License |
|---|---|---|
| Manufacturer | Form MD-3 | Form MD-5 |
| Test License | Form MD-12 | Form MD-13 |
| Applicant Type | Application | License |
|---|---|---|
| Manufacturer | Form MD-3 | Form MD-5 |
| Test License | Form MD-12 | Form MD-13 |
The permission holder in Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch of device in the market and such report shall be submitted every six months for first two years followed by submission of the said report annually for the two more successive years.
Once an Investigational medical device is approved by the Central Licensing Authority and the product is already marketed in the country, then same can be considered as a predicate device & subsequent applicant may obtain license after complying with the requirements of MDR-2017.
No, the person or sponsor shall obtain prior permission from the Central Licensing Authority in Form MD-23 for conduct any clinical investigation in respect of Investigational medical devices.
No. The fee of INR 50000 is charged by the CDSCO for all classes of Medical Device.
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