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India Medical Device Registration

Central Drugs Standard Control Organisation (CDSCO) approval timelines and requirements

6-9 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

Indian Authorized Agent

India Medical Device Registration Overview

India medical device registration through CDSCO typically takes 6-9 months for Class A devices. The official CDSCO target is 3-6 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.India uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Indian Authorized Agent to register devices in India. Registration is valid for 5 years (renewable).

Registration Timeline by Device Class

India uses a 4-class (A, B, C, D) risk-based classification system.

Class A

Registration

Low Risk

Official

3-6 months

Realistic

6-9 months

With Prior Approval

3-5 months

Accelerated with: GHTF country approval (FDA, EU, Japan, Australia, UK)

• GHTF approval provides significant advantage

Local Testing RequiredGMP/QMS Required

Class B

Registration

Medium Risk

Official

4-8 months

Realistic

8-12 months

With Prior Approval

4-7 months

Accelerated with: GHTF country approval

• NABL testing may be required

Local Testing RequiredGMP/QMS Required

Class C

Registration with clinical data

High Risk

Official

6-12 months

Realistic

1-1.5 years

With Prior Approval

6-9 months

Accelerated with: GHTF country approval with predicate

• Clinical data required

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required

Class D

Registration with extensive clinical

Highest Risk

Official

8-15 months

Realistic

1.3-2 years

With Prior Approval

8-12 months

Accelerated with: GHTF country approval

• Indian clinical trials may be required

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your India registration.

FDA 510(k)

GHTF recognition - 6-12 months advantage

6-12 months

EU CE Mark

GHTF recognition - 6-12 months advantage

6-12 months

Japan PMDA

GHTF recognition

6-12 months

Australia TGA

GHTF recognition

6-12 months

Key Requirements

Indian Authorized Agent (for foreign manufacturers)
BIS certification (for 1,485 device types)
NABL testing from accredited labs
Import license
Free Sale Certificate from home country

Registration Validity:

5 years (renewable)

Registration Process Flowchart

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

3-6 months

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.

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Related Resources

CDSCO Regulation News Government Registration Fees

Compare With

🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇧🇷 BrazilANVISA 🇨🇦 CanadaHealth Canada

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.