End-to-end CDSCO licensing, Legal Metrology, and EPR — assembled by senior regulatory experts so you launch with confidence.
Why teams choose us
A single engagement covers every form, every artifact, every regulator interaction.
Manufacturing, import, test, and loan licenses across Class A–D.
Standards selection, gap analysis, and ISO 14971-aligned risk files.
Device master file, design history, labelling, IFU — submission-ready.
Importer/manufacturer registration, label compliance, packaging declarations.
Extended producer responsibility filings, e-waste, return-report management.
CDSCO-recognized representation for foreign manufacturers without an Indian entity.
Six fixed milestones with clear deliverables — you always know where you stand.
Free 30-min scoping call. We confirm Class A/B/C/D, target markets, and the right pathway.
Written regulatory strategy with timelines, costs, and predicate-device analysis.
Technical file, risk management, clinical evaluation, labelling — built to anticipate every query.
Filed with acknowledgement tracking. You see status in real time.
Most submissions clear without queries. If raised, we respond promptly.
License delivered with post-market plan, renewal calendar, and lifecycle SOPs.
Hold licenses on behalf of foreign manufacturers — fully audited and compliant.
“Their dossier was clean and complete, so the CDSCO review moved smoothly with no avoidable back-and-forth.”
Our dossiers are built to anticipate reviewer queries before they’re asked.
Across cardiology, ortho, neuro, imaging, surgical, and IVD categories.
No hourly billing, no scope creep — you see every milestone and cost upfront.
Cleared CDSCO on first review
A medical-device company needed a fast India entry for their cardiac event recorder. We assembled the technical file, predicate analysis, and clinical evaluation, and the MD-9 dossier cleared on first review.
First-pass
CDSCO clearance
Complete
Technical dossier
Single
Predicate analysis
Audit-ready
Handover pack
Quick answers about scope, timelines, and how this engagement runs.
Ask us directly8–12 weeks from submission to license for a clean technical file. Class A is faster (4–6 weeks); Class D and clinical-investigation routes can take 6–9 months.
Yes — we serve as your CDSCO-recognized Authorized Indian Agent. You retain full IP and commercial control while we handle all regulatory work locally.
LMPC applies to pre-packaged products sold in India. Most medical devices in retail or institutional packaging fall under it. We assess applicability during discovery.
Strategy doc, full dossier build, submission, all query rounds, and a post-approval handover kit. No hourly billing.
We register your entity with CPCB, file returns, and manage the buy-back / recycling target compliance year on year.
Tell us about your device and target markets. We’ll send a tailored quote within 24 hours.