On February 2, 2026, the Central Drugs Standard Control Organization (CDSCO) of India issued a draft guideline for the submission of product license applications for in vitro diagnostic (IVD) medical devices to CDSCO.
The guideline provides appropriate direction to foreign manufacturers and Indian Authorized Agents regarding regulatory requirements for medical device registration, import, and sale, as well as the import licensing procedures.
The key contents are as follows.
1) Regulatory authority for IVD Medical devices in India: CDSCO
2) Application submission method: submission through online systems
- MD-14: Medical Device Online Portal (www.cdscomdonline.gov.in) / Fresh, Endorsement, Retention, Subsequent importer
- MD-16: NSWS Portal (https://www.nsws.gov.in) / Test License
3) Classification of IVD medical devices
- Low risk: Class A
- Low moderate risk: Class B
- Moderate high risk: Class C
- High risk: Class D
4) Import application process (Fresh)
- Appointment of applicant/Authorized Agent > Preparation and submission of Form MD-14, DMF, PMF & CDSCO fees (facility and product)
- CDSCO review
- Request for clarification if required
- Grant of fresh import license (MD-15)
- Import and sale in India
5) Checklist – import license (MD-14)
| No. | Checklist |
| 1 | Covering letter |
| 2 | Power of Attorney |
| 3 | Self-attested copy of valid whole sale license or manufacturing license (if any) |
| 4 | Regulatory Certificate along with previous import license (if any) |
| 5 | Quality Management System certificate in respect of legal and actual manufacturing site(s) (wherever applicable) |
| 6 | Site or plant master file as specified in Appendix I of Forth Schedule of MDR 2017. |
| 7 | Device Master File for IVD Medical devices as per Appendix III of part III of Forth Schedule of MDR 2017. |
| 8 | Correlation chart with respect to products list mentioned in MD-14 and FSC submitted. |
| 9 | Testing method preferably in Video (if available) |
| 10 | Fee Chalan |
| 11 | Legal Form |
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
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