CDSCO Medical Device Registration (India)
India now regulates medical devices and in vitro diagnostics comprehensively under the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation (CDSCO). Since October 2023, all classes of device require a license before import or sale, and the documentation bar has risen with it. EvySaif prepares the master files, evidence, and strategy for CDSCO medical device registration, tuned to how the Indian system actually works.
The Indian classification and licensing system
Under the Medical Devices Rules, 2017, devices and IVDs are classified into four risk classes, Class A (low) through Class D (high), using rules based on the IMDRF framework. The route depends on the class and on whether you manufacture or import, and applications are filed through the SUGAM online portal.
Determine the route
Manufacturing licenses for Class A and B devices are handled by the State Licensing Authority (Forms MD-3 and MD-5), while Class C and D manufacturing sits with the Central Licensing Authority (Forms MD-7 and MD-9). Imports of any class run through the Central Licensing Authority.
Apply for the import license
An application in Form MD-14 leads to an Import License in Form MD-15. Where new clinical or performance data is needed, permission to conduct a clinical investigation is sought in Form MD-22, and IVDs have their own clinical performance evaluation route.
Build the master files
A submission is built around a Device Master File (DMF) and a Plant Master File (PMF), with IVDs requiring an IVD Master File. Class C and D devices require clinical evaluation data and a post-market surveillance plan.
Clear review, appoint an agent
Higher-risk or novel products may face Subject Expert Committee review unless they qualify for a waiver, often available where the device held approval for two or more years in a reference country. Foreign manufacturers must appoint an Indian Authorized Agent holding a wholesale license.
Foreign manufacturers: the rules require an Indian Authorized Agent, documented by power of attorney and holding a wholesale license, to file and hold the registration. We work alongside yours rather than acting as it. See also our CDSCO drug and trial submissions page under Regulatory Affairs.
What we prepare
Master filesDevice Master File, Plant Master File, and IVD Master File.
Import license dossiersMD-14 and MD-15 import license application dossiers.
Technical docs and labelingTechnical documentation and India-specific labeling content.
Evidence for Class C and DClinical evaluation reports and PMS plans for higher-risk devices.
IVD performance protocolsClinical performance evaluation protocols for IVDs.
Strategy and query responsesPredicate, reference-country, and grouping strategy, plus responses to CDSCO and SEC queries.
How EvySaif helps
We prepare the master files, evidence, and strategy for CDSCO registration, tuned to how the Indian system works. We advise on the predicate, reference-country, and grouping choices that shorten the path, and because the rules require an Indian Authorized Agent to file, we work alongside yours.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and CDSCO is our home regulator. We prepare the master files and evidence with direct familiarity with how CDSCO reviews device and IVD applications, and we advise on the predicate, reference-country, and grouping choices that shorten the path.
Frequently asked questions
MD-14 is the application for an import license; MD-15 is the import license itself, granted by the Central Licensing Authority for imported devices and IVDs.
Since October 2023, all classes, including Class A sterile and measuring devices, require a license before import or sale in India. The earlier voluntary-registration phase has ended.
Yes. A foreign manufacturer must appoint an Indian Authorized Agent, documented by power of attorney and holding a wholesale license. We prepare the dossier and work alongside that agent.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalRegistering a device in India?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal