510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
CDSCO medical device registration (India)
What class is my device under Indian rules, and what does CDSCO need from me?
- AuthorityCDSCO
- JurisdictionIndia
- Type Market-access route
- Our scopeDelivered by Prequel
What this route requires
Medical devices in India are regulated under the Medical Devices Rules, 2017. Devices fall into risk classes A, B, C and D, determined by intended use, invasiveness, duration of contact and other factors set out in the classification criteria.
The class determines which authority licenses the device, which application route applies, and what evidence has to accompany it. Import and domestic manufacture follow different application routes.
Getting classification wrong is expensive in a specific way: it is usually discovered after testing and evidence have already been commissioned against the wrong requirements.
Applies to
Manufacturers and importers placing a medical device on the Indian market.
Our scope
How Prequel supports it
- Determine classification under the Medical Devices Rules 2017 and document the rationale
- Establish the import or manufacturing route that applies
- Build the testing and clinical evidence plan against that route
- Prepare the dossier and maintain the submission checklist
- Coordinate the submission and manage queries through to a decision
Delivered by Prequel. Where a step needs a specialist partner — laboratory testing in particular — we define the scope and review the output, and we say so rather than implying it is in-house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
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?
Not sure CDSCO — India is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.