India medical device registration timeline

Source-linked clocks

Central Drugs Standard Control Organisation (CDSCO) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) classification system.

4 pathways4 of 4 clocks verifiedvalidity Perpetual, not a fixed term. A manufacturing licence or loan licence in Form MD-5, MD-6, MD-9 or MD-10 stays valid indefinitely under Rule 29(1) and an import licence in Form MD-15 under Rule 37, in each case provided the retention fee is paid before every fifth anniversary. Miss it and the licence is deemed cancelled, after a 180-day late window with a 2% monthly surcharge for manufacturing licences and a 90-day window for import licences.MDSAP not acceptedreviewed 2026-08-30cdsco.gov.in

Class / pathway	Review clock	Planning total	With prior approval	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))	45 days	6-9 months	3-5 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)	45-140 days	8-12 months	4-7 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	90 days	1-1.5 years	6-9 months	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	90 days	1.3-2 years	8-12 months	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

India Medical Device Registration Process

Step-by-step CDSCO registration process. Total estimated timeline: 6-9 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by CDSCO. Appoint a Indian Authorized Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to CDSCO including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

CDSCO reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

45 days

In-depth technical assessment of device safety and performance. CDSCO may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, CDSCO issues India market authorization certificate.

Summary: The India medical device registration process through Central Drugs Standard Control Organisation (CDSCO) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

FDA 510(k)/PMAA free sale certificate from the United States triggers Rule 36(3): the import licence is granted without clinical investigation. Rule 63(1) fourth proviso additionally waives clinical investigation results for a device without a predicate if it has been US-approved and marketed there for at least two years. Neither provision shortens the nine-month Rule 36(1) decision period.None published — the saving is the clinical investigation, not the clock

EU CE MarkA free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.None published — the saving is the clinical investigation, not the clock

Japan PMDANamed in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.None published — the saving is the clinical investigation, not the clock

Australia TGANamed in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.None published — the saving is the clinical investigation, not the clock

Health CanadaNamed in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.None published — the saving is the clinical investigation, not the clock

UK MHRANamed only in the Rule 63(1) proviso, which waives clinical investigation results for a no-predicate device marketed in the UK for at least two years. The UK is not in the Rule 36(3) list.None published

Key requirements

Indian Authorized Agent (for foreign manufacturers)
Rule 7: the device must meet the applicable Bureau of Indian Standards standard, or an ISO, IEC or pharmacopoeial standard where BIS has not laid one down. This is a conformity obligation in the dossier, not a separate BIS licence, which is only compulsory for the narrow set of products covered by a Quality Control Order.
NABL testing from accredited labs
Import license
Free Sale Certificate from home country
Import licence (Rule 36(1)): CLA grants or rejects within nine months of application; clinical investigation permission within 90 days of the MD-22 application (Rule 52(ii))
No-predicate permission (MD-26) 120 days extendable by 30; new IVD permission (MD-28) 90 days extendable by 30; test licence (MD-16) 30 days; personal-use import (MD-20) 7 days; sale registration (MD-41) 10 days

Primary regulator sources

cdsco.gov.in · CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against CDSCO publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:india:class-a