CDSCO may reject a medical device import license application due to errors in classification, incomplete documentation, or non-compliance with Indian regulatory requirements. Therefore, importers and foreign manufacturers must carefully prepare their MD14 application to avoid delays or rejection.
The most common reasons include:
1. Incorrect medical device classification under CDSCO
2. Incomplete or inconsistent documentation
3. Errors in Device Master File (DMF) or Plant Master File (PMF)
4. Labeling not aligned with Indian regulations
5. Mismatch in Free Sale Certificate or ISO details
6. Improper appointment of Indian Authorized Agent
Moreover, many applicants underestimate CDSCO’s documentation expectations. As a result, even small inconsistencies can lead to queries or rejection.
In addition, ensure that all documents for medical device import are complete and compliant before submission.
If you want to reduce rejection risk and achieve faster approval, working with an expert through our CDSCO Consultant for Medical Device Import in India can help streamline the process and improve success rate & approval timelines.
Why Does CDSCO Reject Medical Device Import License Applications in India?
Why Does CDSCO Reject Medical Device Import License Applications in India?