CDSCO · structured requirements

🇮🇳 India medical device regulatory data

Explore the medical device requirements currently available for India, organized by topic and linked to official sources.

7 facts3 dimensions2 official sourceslatest verification 2026-08-13

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

authorization.duration

Type: Indefinite With Retention
Description: Import/manufacture licences remain valid perpetually unless suspended/cancelled, subject to retention fee every 5 years.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

authorization.lapse

Failure beyond the permitted period can result in deemed cancellation and need for a fresh licence.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

authorization.renewal

Pay retention fee every 5 years; a late period up to 90 days may apply with fee.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

change.available-outcomes

Outcomes: Notification Or Administrative Update
Prior Approval Amendment Or Variation
New Registration Or New Application
Description: Major changes require prior approval; post-approval changes and retention are separate submissions.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

change.new-application-triggers

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

market-entry.local-role

Archetype: Manufacturer Mandated Authorized Representative
Name: Indian Authorized Agent
Required For Foreign: yes
Registration Relation: Holds Or Submits Import Licence On Behalf Of Foreign Manufacturer
Importer Relation: agent_must_have_eligible_sale/manufacture/wholesale_licence
Distributor Relation: May Be Same Or Separate
Combination: Allowed Subject To Licensing

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

market-entry.representative-change

Path Code: Post Approval Agent Change With Fresh Power Of Attorney
Fresh Registration: Usually No If Approved Change
Minimum Handover: fresh power of attorney
old agent termination
licence and dossier records
post-market and complaint records
import inventory
label updates
Notes: A correctly processed agent change can retain the licence number; do not wait for the five-year retention filing if change approval is required earlier.