Regulatory
Regulatory status, stated plainly.
Under development toward CDSCO Class C. Not an approved or certified medical device.
We publish this page because the honest version is more useful to a hospital than a reassuring one, and because a claim we cannot support is the fastest way to end a procurement conversation.
Classification
Central Drugs Standard Control Organisation (India)
Under development toward CDSCO Class C. Not an approved or certified medical device.
Under India’s Medical Device Rules, software intended to inform clinical management is a medical device in its own right. Software that processes human genetic information to support diagnosis sits in the higher risk classes; for NexaMed, Class C is the floor rather than the target — there is no lower classification we could reasonably argue for.
The route is a manufacturing licence application to the state licensing authority, supported by a quality management system and a technical file. We are working toward that. We have not completed it.
The most consequential design decision in this product is that it states a metabolizer phenotype and never a drug dose. Software that recommends a dose is a materially higher-risk device. That boundary is why NexaMed is what it is, and it is enforced in code rather than by policy.
In place
What exists today.
- A named Clinical Safety Officer, a practising gastroenterologist, supervises clinical content. We can put a hospital in touch with them on request.
- Clinical content — the gene panel, the evidence tiers, the report wording and the disclaimers — goes through a written, versioned approval instrument rather than through conversation, and a defined list of changes voids an approval and forces it to be sought again.
- Questions we cannot answer as engineers are recorded as open clinical questions and answered by a clinician in writing, verbatim. Where two clinical statements conflict, we surface the conflict rather than choosing between them.
- Every model, dataset and third-party library is licence-audited before adoption, and an ambiguous licence is treated as blocked. This has removed components that were already in the product.
- Design decisions that would raise the risk classification are refused deliberately. The system states a phenotype and never a dose, and a test fails the build if that is crossed.
- Access control, tenant isolation and an audit trail are built in rather than planned.
Not in place
What does not exist today.
Stated explicitly, because omission on a page like this reads as possession:
- No CDSCO manufacturing or import licence has been granted, and no application has completed.
- No ISO 13485 quality management system certification. No notified body has been engaged.
- No clinical validation study has been published. The product has not been through a formal clinical performance evaluation.
- No independent third-party security audit.
- The clinical content approval instrument is in execution and is not yet signed. Until it is, the clinical content is reviewed but not formally approved, and we describe it that way.
Status
- Target class
- Class C (moderate–high risk)
- Route
- State manufacturing licence application
- Licence granted
- No
- Application completed
- No
Not an approved or certified medical device. Institutions using NexaMed today do so in non-clinical, investigational settings.
Ask us the awkward ones.
If you are evaluating this for a hospital and need documentation we have not published — the intended-use statement, the panel gene list with its evidence sources, the clinical approval instrument, or the laboratory assay requirements — write to us.
Where the answer is that a document does not exist yet, that is what we will tell you.
office@nexavelos.com →