Medical Device Regulatory & Compliance Services
Full-spectrum medical device regulatory and compliance services - CDSCO manufacturing, import and wholesale licences under the Medical Devices Rules 2017, US FDA registration and 510(k), ISO 13485, and CE marking/EU MDR readiness. — Chartered Solution.
Medical Device Regulatory & Compliance Services - Overview
Full-spectrum medical device regulatory and compliance services - CDSCO manufacturing, import and wholesale licences under the Medical Devices Rules 2017, US FDA registration and 510(k), ISO 13485, and CE marking/EU MDR readiness.
What We Provide
- CDSCO manufacturing licences (MD-5, MD-9)
- CDSCO import licences (MD-15) & wholesale (MD-42)
- US FDA establishment registration & device listing
- FDA 510(k) submission & UDI compliance
- ISO 13485 / ICMED 13485 certification
- CE marking & EU MDR pathway support
Who Needs This Service?
- Medical device manufacturers seeking CDSCO licences
- Importers and distributors bringing devices into India
- Exporters targeting US FDA and EU MDR markets
Eligibility
- Indian entities or authorised agents for CDSCO licences
- Overseas manufacturers through an Indian authorised agent
Documents Required
- Company registration & GST
- Manufacturing premises documents (for manufacturing)
- Technical dossier / Device Master File
- ISO 13485 / QMS documentation
- Free Sale Certificate (import)
- Power of Attorney (overseas manufacturer)
Our Process
- 1ClassificationClassify the device (A/B/C/D) under MDR 2017.
- 2Dossier & QMSPrepare technical and quality documents.
- 3ApplicationFile with CDSCO / State authority.
- 4Audit & approvalCoordinate site audits and approvals.
Pricing & Timeline
CDSCO / State licensing authority fees apply per the Medical Devices Rules, 2017.
Regulatory consultancy fees depend on licence type, device class and scope.
Varies by licence - manufacturing (Class A/B): 4–8 weeks; import: 6–12 weeks.
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.
Need Medical Device Regulatory & Compliance Services?
Our team at Chartered Solution is here to help. Get in touch for a personalised consultation.
Medical Device Manufacturing Licence (MD-5) – Class A & B
Manufacturing licence assistance for Class A & B medical devices in India.
Medical Device Manufacturing Licence (MD-9) – Class C & D
Manufacturing licence assistance for Class C & D medical devices in India.
Medical Device Import Licence (MD-15)
Import licence to bring notified medical devices into India.
Medical Device Wholesale Licence (MD-42)
Wholesale licence to stock, exhibit and distribute medical devices in India.