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Medical Device Labeling Compliance / EU MDR Labeling

Review and compliance assistance for medical device labelling and packaging under EU MDR requirements, including symbols, languages and IFU (Instructions for Use). — Chartered Solution.

Medical Device Regulatory

Medical Device Labeling Compliance / EU MDR Labeling - Overview

Review and compliance assistance for medical device labelling and packaging under EU MDR requirements, including symbols, languages and IFU (Instructions for Use).

What We Provide

Label & packaging review (EU MDR)
Symbol & language compliance
Instructions for Use (IFU) review
Label claims review
Compliance documentation

Who Needs This Service?

Medical device manufacturers and importers in India
Companies targeting US FDA and EU markets
Distributors and authorised representatives of devices

Eligibility

Indian entities (or authorised agents) manufacturing / importing notified medical devices
Overseas manufacturers with an Indian authorised agent for import licences

Documents Required

Company registration & GST
Manufacturing site / premises documents
Technical dossier & device master file
QMS / ISO 13485 documentation
Free Sale Certificate (for import licences)
Power of Attorney (overseas manufacturer)

Our Process

1
Classification
Classify the device under the applicable rules.
2
Dossier
Prepare technical and QMS documentation.
3
Application
File with CDSCO / State authority.
4
Audit & approval
Coordinate audits and approvals.

Pricing & Timeline

Government / Authority Fees

CDSCO / State licensing authority fees apply as per the Medical Devices Rules, 2017.

Professional Fees

Regulatory consultancy fees depend on licence type and classification - quoted upfront.

Estimated Timeline

Class A/B manufacturing: 4–8 weeks. Import licences: 6–12 weeks. CDSCO timelines may extend.

Why Choose Chartered Solution?

Dedicated expert assigned to every engagement
Transparent, all-inclusive professional fees - no hidden charges
End-to-end documentation, filing and follow-up support
PAN-India service, delivered 100% online where possible

Frequently Asked Questions

Professional fees depend on the scope, entity type, and documents required. Contact us at +91 88155 53899 for a transparent, all-inclusive quote before you start.

Timelines vary by authority and department. We share an expected timeline before starting and keep you updated at every step on WhatsApp.

Yes. Chartered Solution serves clients across India - most registrations and filings are completed 100% online with doorstep delivery of certificates.

A basic document set is listed on this page. Our team sends a complete, service-specific checklist after your enquiry.

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