INDIA- MDR 2017 G.S.R 78 (E)

Navigate MDR 2017 Licensing with Expert Guidance

At Alpine Quality Consultants, we provide expert consultancy services to assist medical device manufacturers and importers in obtaining Test Licence, Manufacturing Licence, and Loan Licence as per the Medical Devices Rules (MDR) 2017, G.S.R 78 (E). Our structured approach ensures seamless regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) requirements in India.

Understanding MDR 2017 Licensing Requirements

The Medical Devices Rules, 2017 (G.S.R 78 (E)), outline the regulatory framework for Medical Devices and In-Vitro Diagnostics (IVDs) in India. To manufacture, import, test, or market medical devices, companies must obtain specific licences from CDSCO or State Licensing Authorities (SLA) based on risk classification.

Types of Licences Under MDR 2017:

Test Licence (Form MD-16 & MD-17)

Required for conducting clinical investigations, performance evaluations, and R&D testing of medical devices before market approval.

Manufacturing Licence (Form MD-5 & MD-9)

Required for companies manufacturing medical devices in India, ensuring compliance with Good Manufacturing Practices (GMP) and quality assurance standards.

Loan Licence (Form MD-6 & MD-10)

Required when a company wishes to manufacture medical devices at another licensed facility under a contractual agreement, ensuring compliance with regulatory standards.

Our Consultancy Services

We provide comprehensive support for obtaining licences under MDR 2017, including:

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Regulatory Assessment & Gap Analysis

Evaluation of business operations to determine applicable licences.
Identification of compliance gaps based on CDSCO regulations.
Strategic roadmap for obtaining Test, Manufacturing, or Loan Licences.

Documentation & Application Preparation

Preparation of dossier, quality manuals, and regulatory submissions.
Assistance in drafting required forms (MD-16, MD-17, MD-5, MD-9, MD-6, MD-10).
Compilation of technical and safety data for submission.

Facility Compliance & Audit Readiness

Guidance on infrastructure, equipment, and process validation.
Assistance in GMP compliance and quality management system implementation.
Pre-audit readiness assessment to ensure regulatory approval.

Liaison with CDSCO & SLA Authorities

Coordination with regulatory bodies for approvals and clarifications.
Submission of applications and follow-ups with CDSCO/SLA.
Handling queries and ensuring timely approvals.

Post-Licence Compliance & Renewal Support

Assistance with post-approval compliance and regulatory updates.
Licence renewals and amendments as per MDR 2017 requirements.
Ongoing support for audits and regulatory inspections.

Why Choose Alpine Quality Consultants?

Expertise in Indian Medical Device Regulations

In-depth knowledge of CDSCO processes and MDR 2017 compliance.

End-to-End Licensing Support

From application preparation to approval, we handle the entire process.

Efficient Approval Process

Minimized delays with a streamlined regulatory approach.

Continuous Compliance Assistance

Guidance beyond approval to maintain regulatory readiness.

Expert Guidance for Import Licence under Medical Device Rules (MDR) 2017

Are you looking to import medical devices into India? Navigating the regulatory landscape can be complex, but our Import Licence Consultancy ensures a smooth and hassle-free process. We specialize in assisting businesses in obtaining import licenses as per the Medical Device Rules (MDR) 2017, G.S.R 78 (E), under the Drugs and Cosmetics Act, 1940.

Our Services Include:

Eligibility Assessment:

Determine if your medical device requires an import license under MDR 2017.

Documentation Assistance:

Preparation and verification of essential documents, including Form MD-14 and MD-15.

Application Submission:

Filing the import license application with CDSCO.

Regulatory Compliance:

Ensuring adherence to the quality and safety standards as per MDR 2017.

Liaison with CDSCO:

Handling queries, responding to notices, and facilitating approvals.

Post-License Support:

Assistance with renewals, modifications, and compliance audits.

Understanding MDR 2017 – G.S.R 78 (E)

The Medical Device Rules (MDR) 2017 were introduced to streamline the import, manufacturing, and distribution of medical devices in India. G.S.R 78 (E), notified on January 31, 2017, outlines the regulatory framework for obtaining import licenses. The key aspects include:

Categorization of medical devices based on risk classification (Class A, B, C, D)
Registration and licensing requirements
Compliance with Indian Standards or equivalent international norms

Oversight by CDSCO and State Licensing Authorities

Who Needs an Import License?

Importers dealing with medical devices, diagnostic equipment, IVDs (In-Vitro Diagnostics), and related healthcare products must obtain an import license before bringing products into India.

Required Documents for Import License Application

Covering letter
Form MD-14 (Application form for import license)
Power of Attorney (PoA)
ISO 13485 Certification (Quality Management System for Medical Devices)
Free Sale Certificate (FSC) from the country of origin
Device Master File (DMF) and Plant Master File (PMF)
Undertaking of compliance with Good Manufacturing Practices (GMP)

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