CDSCO · South & Southeast AsiaEvery India dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Search official CDSCO device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official CDSCO regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current CDSCO application, review, and renewal fees.
Estimate the likely CDSCO pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent CDSCO policy, guidance, and compliance updates.
Describe your device and get a preliminary CDSCO risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other India requirements.
Describe a device and find comparable products in the CDSCO registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Common questions about changing a registered medical device in India. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 25 official sources · latest verification 2026-10-21
CDSCO registration fees in USD · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Import licence - Class A manufacturing site | USD 1,000 | Verified |
| Import licence - Class A device | USD 50 | Verified |
| Import licence - Class B manufacturing site | USD 2,000 | Verified |
| Import licence - Class B device | USD 1,000 | Verified |
Central Drugs Standard Control Organisation (CDSCO) review clocks and planning ranges · 4-class (A, B, C, D) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class A(Registration) Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii)) GHTF approval provides significant advantage | 45 days | 6-9 months | Verified |
| Class B(Registration) Rule 20(6) chain: Notified Body audit within 90 days of application, NB report to the licensing authority within 30 days of the audit, licence decision within 20 days of the audit report (140 days total) Licence grant-or-reject clock is 45 days where it applies (Rule 20(4)) NABL testing may be required | 45-140 days | 8-12 months | Verified |
| Class C(Registration with clinical data) Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report Clinical data required | 90 days | 1-1.5 years | Verified |
| Class D(Registration with extensive clinical) Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report Indian clinical trials may be required | 90 days | 1.3-2 years | Verified |
Official CDSCO rules and guidance · 36 of 36 documents linked to official sources
Computed from 71,807 official CDSCO license records · data as of 2026-08-26
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting India work.
Connect the CDSCO route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against CDSCO administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to CDSCO evidence, notification, timing, and implementation questions.
Assess a current CDSCO update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for India (CDSCO).
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