| 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== |
| Device Classification Guidelines | Medical Devices are classified into four class based on the risk parameter as specified in Part I of the First Schedule of the Medical Devices Rules, 2017 | Click Here |
| Registration Process | Guidance document for Registration of Non Notified Medical Devices..pdfRegulation of sale of medical devices via registration of premises under MDR, 2017Registration 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. |