CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Medical devices
What class is my device, and what evidence does that route require?
How this sector is regulated
Medical devices in India are regulated under the Medical Devices Rules, 2017, which assign each device a risk class from A to D based on intended use, invasiveness and duration of contact. The class determines the licensing authority, the application route and the evidence required.
For the European market, Regulation (EU) 2017/745 sets its own classification, clinical evaluation and technical documentation requirements, and makes post-market obligations continuous rather than one-off. In the United States the route depends on whether a predicate exists — 510(k) where one does, De Novo where the device is novel but low to moderate risk, and PMA for Class III.
ISO 13485 and ISO 14971 underpin all three markets, which is why they are worth building properly once rather than three times.
Where programmes usually lose time
Evidence generated before classification is settled
Classification determines what testing and what clinical evidence the route requires. Commissioning either before the classification is documented risks producing evidence against requirements that do not apply — discovered late, and rarely reusable.
Your route
Regulatory routes that apply here
Which one governs your product depends on its composition, its intended use and what you intend to claim.
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
De Novo — US FDA
There is no predicate for my device. What route is left?
PMA — US FDA
My device is high risk. What does a PMA actually demand?
EU MDR 2017/745
What does EU MDR require beyond what I already have?
ISO 13485
What does a device QMS need to contain, and are we audit ready?
ISO 14971
How do I connect hazards to controls, and controls to evidence?
Delivery
The services behind that work
The route sets what has to be produced. These are the teams that produce it — the same functional capability we have run for CROs and sponsors for years.
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
Biostatistics & Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
Quality Assurance & Audits
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
Clinical Trial Management
Program coordination from feasibility through closeout under client SOPs.
When people call us
Typical situations
Determining the class
You need the classification documented with reasoning that will hold, before any testing is commissioned against it.
Building the technical file
The evidence exists in pieces and needs assembling into documentation an authority or notified body will accept.
Standing up a QMS
You need ISO 13485 in place, built to describe how the organisation actually works rather than to pass one audit.
Clinical investigation required
The route needs clinical evidence and the study has to be designed, approved and run to ISO 14155.
The limits of what we cover
Classification, risk management, technical documentation, quality systems and clinical evidence are our own work, for India and the European Union. US FDA submissions — 510(k), De Novo and PMA — are run with a US regulatory specialist under our scope and review: we build the strategy and the package, and the filing goes through that partner.
Other sectors we work in
Nutraceuticals
FSSAI category and claims work for supplements, functional foods and foods for special dietary use.
Cosmetics
COS-1 and COS-2 import registration, State licensing, labelling and claim control for the Indian market.
Pharmaceuticals
Clinical trial approval, study execution and the full functional stack — our longest-running capability.
Working on a medical device product?
Send us the product, the claims you want to make and the market you are going to. We will come back on the route and the evidence it needs — before anyone commissions a test.