Medical Device Regulatory Requirements in India
| Regulatory Authority |
Central Drugs Standard Control Organisation (CDSCO) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Medical Device Rules-2023 (Same Regulations for IVD)
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNg== |
| Registration Process |
Guidance document for Registration of Non Notified Medical Devices..pdf
Regulation of sale of medical devices via registration of premises under MDR, 2017
Registration of certain medical devices
| Click Here
|
| Registration Timeline |
9 to 11 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Additional Information |
The validity of the import license is 5 years. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025