The regulatory path
to your target market.
CDSCO, BIS, CE Mark, FDA — each market has its own framework, its own timeline, and its own failure modes. We know them. We prepare submissions that move.
India's medical device regulatory framework under MDR 2017 is mature but non-trivial — classification, import licensing, loan licence structuring, and SUGAM portal submissions each have their own requirements and their own timelines. Getting them wrong means re-submission, not just a delay.
We prepare the complete technical dossier for Class A–D device registration, manage CDSCO correspondence, and structure import or loan licence arrangements where required. Direct working knowledge of MDR 2017 and its amendments.
Bureau of Indian Standards certification is mandatory for an expanding list of medical devices sold in India. BIS Scheme-I has specific documentation requirements, and factory inspections require preparation to go smoothly.
We prepare BIS documentation, manage the application lifecycle, and prepare your team for factory inspection — including the technical questions inspectors consistently ask. We liaise with BIS throughout the process so you're not managing that correspondence yourself.
EU MDR 2017/745 raised the bar substantially compared to the MDD. Clinical evidence requirements are stricter, post-market obligations are ongoing, and notified bodies are more demanding on technical documentation quality.
We prepare technical documentation under EU MDR and IVDR — clinical evaluation reports, risk management files, PMS plans, usability files, and software lifecycle documentation. We are particularly experienced in IEC 60601-series and IEC 62304 documentation, where many manufacturers struggle with notified body queries.
FDA 510(k) submissions require a predicate device strategy, substantial equivalence argument, performance testing evidence, and labelling that satisfies FDA's requirements. De Novo requests require a classification proposal, special controls rationale, and more detailed safety and effectiveness data.
We support 510(k) and De Novo submission preparation — predicate selection, substantial equivalence narrative, performance testing specification, and submission package assembly. We do not hold FDA registration numbers or act as US Agent, but we prepare the technical content your US Agent and legal counsel need.
Entering multiple markets sequentially — or simultaneously — requires a regulatory strategy that sequences submissions intelligently, reuses technical evidence across markets, and avoids creating conflicting documentation.
We map the regulatory requirements for your target markets, identify evidence overlap and gaps, and build a submission sequence that uses your resources efficiently. Typical combinations include India + CE, India + CE + US, and India + Southeast Asia.
A device-specific roadmap covering applicable regulations, submission pathway, timeline, and effort estimate for your target market.
Complete submission-ready technical file or dossier prepared to the required regulatory standard.
Prepared application package for CDSCO registration or BIS certification, ready for submission.
Sequenced regulatory strategy for two or more markets with shared evidence mapping and submission calendar.
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