Most CDSCO timelines slip not because the device fails, but because the dossier invites questions. We build submissions that anticipate the query before the reviewer raises it, then carry you through licensing, audits and post-approval obligations.
CDSCO approval is rarely refused outright. It is delayed, one query at a time, until a six-month plan becomes an eighteen-month one. These are the causes we see most often.
Classification drives the licence type, the authority, the fee, the evidence burden and the timeline. Get it wrong and every downstream document is built on a false foundation. Reclassification mid-process means starting again.
Reviewers raise questions where documentation is thin, inconsistent or silent. Each query cycle adds weeks. A dossier assembled to satisfy a checklist behaves very differently from one assembled to answer a reviewer's likely objections.
Foreign manufacturers frequently appoint their distributor as agent. The licence then sits in the distributor's name. Changing distributors later means surrendering and reapplying, with all the delay that implies.
Class A and B manufacturing sits with the State Licensing Authority. Class C and D sits with the Central Licensing Authority. Imports are always central. Filing to the wrong authority costs the entire submission window.
The PMF and DMF are the substance of the submission, not covering paperwork. Weak master files are the single most common trigger for extended query cycles and for adverse findings during the licensing audit.
Licensing for Class C and D includes an inspection. Organizations often prepare the dossier thoroughly and the quality system barely at all, then face findings on a system that was never built to be examined.
Import for demonstration, evaluation, clinical investigation or training requires its own permission. Teams frequently learn this after shipment has been arranged, stranding consignments at port.
Licence renewal windows, change notifications, adverse event reporting and post-market surveillance carry no reminder. Non-compliance surfaces at renewal or inspection, when the remedy is expensive.
Every medical device and IVD placed on the Indian market falls under the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation under the Drug Controller General of India. Classification determines the licensing authority, the evidence required and the time it takes.
Non-sterile, non-measuring Class A follows a simplified registration route. Sterile or measuring Class A requires a manufacturing licence.
Manufacturing licence required, granted by the State Licensing Authority following documentation review and inspection.
Central licensing with a fuller evidence burden, mandatory audit and typically longer review cycles.
Highest evidence threshold. Clinical data expectations, rigorous master files and central inspection apply.
Import licensing is administered centrally for all classes, regardless of device risk category.
The right pathway depends on whether you manufacture, import, distribute or need product for evaluation. We identify the correct route before any application is drafted.
A start-up filing its first submission and a multi-site manufacturer managing a licence portfolio need very different things from a regulatory partner.
The device works. The funding is time-bound. Nobody in the building has taken a product through CDSCO before, and every month of delay is a month of runway.
You hold licences already. One or two people carry regulatory alongside other duties, and each new product or market stretches capacity that is already fully committed.
An established regulatory function exists. The challenge is consistency across sites, visibility across a large licence portfolio, and specialist depth for the submissions that fall outside routine.
Whether you manufacture in India, import into India, or manufacture in India for global markets, the regulatory pathway differs materially. We work across all three.
Site licensing, plant and device master files, QMS build, licensing inspection support across Class A to D.
Authorised Indian Agent structuring, import licensing, test licences and consignment clearance support.
CE marking, US FDA pathways, WHO PQ, free sale and market standing certificates for outbound markets.
Renewals, change notification, vigilance reporting, PSUR and ongoing compliance maintenance.
From the first classification decision through to post-market obligations that continue for the life of the product.
Indian manufacturers exporting, and global manufacturers entering India, both need pathways that work in more than one jurisdiction. We plan submissions so that work done for one market carries into the next.
Technical file and design dossier preparation, CE marking strategy, notified body coordination, Clinical Evaluation Report and Performance Evaluation Report, EU authorised representative guidance.
510(k) premarket notification, PMA support, De Novo pathway, QMSR and 21 CFR 820 compliance, establishment registration and device listing, US agent guidance.
WHO prequalification dossiers, Japan PMDA submissions, Brazil ANVISA registration, Health Canada licensing and China NMPA pathway assessment.
CDSCO is our primary practice rather than one line on a global service list. We know how the authorities read a dossier, where queries originate, and what a licensing inspection actually examines.
Submissions fail at the QMS as often as at the dossier. We build both, so the quality system that supports your application is the same one that survives the audit.
Dossiers are assembled against likely reviewer objections rather than against a submission checklist. Fewer query cycles is the difference between six months and eighteen.
A boutique practice means the person who scoped your submission is the person who writes it. Nothing is delegated down to a junior team after the proposal is signed.
Work done for CDSCO is structured so it carries into EU MDR, US FDA and WHO PQ submissions rather than being rebuilt from scratch for each market.
Licences require renewal, changes require notification, and vigilance obligations continue for the product life. We build the system that keeps those obligations from lapsing.
Send us the device and its intended use. We will tell you the likely classification, the licence you need, the authority you file with and a realistic timeline, at no cost.