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Why Choose JR Compliance?

1

Speed

Quick quotes!

2

Service

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3

Quality

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JR Compliance

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10+
Years

WhyChoose JR Compliance?

1

Speed

Quotes in seconds, certification in days! Our streamlined process ensures quick turnaround.

2

Service

Dedicated support team, quick replies! We're available whenever you need assistance.

3

Quality

Expert team with industry knowledge! 100% compliance guaranteed with thorough documentation.

Benefits of In Vitro Diagnostics Registration

Mandatory for IVD market access in India
Class A, B, C, D IVD registration
Import and manufacturing license
Expert regulatory guidance
Clinical performance evaluation
Quality management compliance
Quick processing
Renewal support
Pan-India distribution

Understand Your In Vitro Diagnostics Registration Before Applying

Simple steps to get your certification done quickly

1

IVD Classification

Classify IVD under IVDR 2017 (Class A/B/C/D).

2

Documentation

Prepare technical file and performance data.

3

Testing

Get IVD tested at approved laboratories.

4

CDSCO Application

Submit application on CDSCO portal.

5

Registration Grant

Receive CDSCO IVD registration certificate.

Documents Required

Keep these documents ready for a smooth application process

Company registration documents
Manufacturing license
Device master file
Quality management certificate (ISO 13485)
Performance evaluation data
Analytical and clinical study reports
Labeling and IFU
Declaration of conformity

Common Questions Answered

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In Vitro Diagnostics Registration?

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