Lumbar Healthtech Pvt Ltd

Global Regulatory Expertise

INDIA - CDSCO

UNITED STATES - US FDA

Medical Device

Invitro Diagnostic Medical Device

Cosmetics

UNITED STATES - US FDA

Medical Device

In Vitro Diagnostic Medical device

EUROPEAN UNION - EU Regulatory

Medical Device

In Vitro Diagnostic Medical Device

BRAZIL-ANVISA

EUROPEAN UNION - EU Regulatory

Medical Device

In Vitro Diagnostic Medical Device.

Key Steps for Medical Device Registration in India (CDSCO)

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

Device Classification
Medical devices are classified as Class A, B, C, or D based on risk level under the Medical Devices Rules, 2017.
Indian Authorised Agent
Foreign manufacturers must appoint an Indian Authorised Agent to represent them and handle regulatory submissions.
Documentation Preparation
Prepare required documents such as Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, labelling/IFU, manufacturing details, and Free Sale Certificate (for imported devices).
Online Application Submission
Submit the application through the CDSCO SUGAM portal with the required forms, documents, and government fees.
Inspection or Audit
Depending on device class, CDSCO or a notified body may conduct a manufacturing site inspection or audit.
Licence Grant
After successful review, CDSCO grants the manufacturing or import licence.
Post-Approval Compliance
Maintain compliance through retention fees, post-market surveillance, and change notifications when applicable.

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CDSCO Manufacturing License — Medical Device Manufacturing in India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

Setting up a medical device manufacturing unit in India requires approval from the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules (MDR), 2017.
This license allows companies to legally manufacture medical devices while ensuring compliance with quality and safety standards.

What is a CDSCO Manufacturing License?

A CDSCO Manufacturing License permits companies to manufacture Class A, B, C, or D medical devices in India. The manufacturing facility must follow Quality Management System (QMS) requirements and regulatory guidelines.

Who Needs This License?

Companies manufacturing the following products require this license:

Medical devices (Class A–D)
In Vitro Diagnostic (IVD) devices
Surgical instruments
Implants and orthopedic devices
Diagnostic and healthcare equipment

Types of Manufacturing Licenses

Form MD-5 – Manufacturing license for Class A & B devices
Form MD-9 – Manufacturing license for Class C & D devices
Form MD-10 – Loan license for Class A & B devices
Form MD-12 – Loan license for Class C & D devices

This license ensures that the manufacturing unit complies with CDSCO regulatory standards.

Request Consultation

CDSCO Import License — Medical Device Import in India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

CDSCO Import License — Medical Device Import in India

Importing medical devices into India requires approval from the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules (MDR), 2017. This license allows companies to legally import and market medical devices in India.

What is a CDSCO Import License?

A CDSCO Import License permits companies to import Class A, B, C, or D medical devices into India. The device must comply with CDSCO regulatory requirements and quality standards.

Who Needs This License?

Any company importing medical devices into India requires this license, including:

Medical devices (Class A–D)
In Vitro Diagnostic (IVD) devices
Surgical instruments
Implants and orthopedic devices
Diagnostic and healthcare equipment

Types of Import Licenses

Form MD-14 — Application for Import License
Form MD-15 — Import License granted by CDSCO
Form MD-16 - Application for Test Import License
Form MD-17 - Test Import License grant by CDSCO

This license ensures that imported medical devices meet safety, quality, and regulatory standards before entering the Indian market.

Reqeust Consultation

OUR SERVICES

CDSCO Medical Device Registration

End-to-end support for registration and licensing of medical devices in India under MDR-2017.

Import License Assistance

CDSCO Medical Device Registration

Preparation and submission of applications for CDSCO import licenses for medical devices and IVDs.

Manufacturing License Support

CDSCO Medical Device Registration

Regulatory Strategy & Product Classification

Guidance for obtaining CDSCO manufacturing licenses for Class A, B, C, and D medical devices.

Regulatory Strategy & Product Classification

Assessment of device classification and development of regulatory pathways for India and global markets.

Technical Documentation Preparation

Regulatory Strategy & Product Classification

Technical Documentation Preparation

Preparation and review of Device Master File (DMF), Plant Master File (PMF), and other regulatory documentation.

USFDA Regulatory Consulting

Regulatory Strategy & Product Classification

Technical Documentation Preparation

Support for USFDA regulatory requirements, including regulatory strategy and submission guidance.

CE Marking Support

Regulatory Compliance & Post-Approval Support

Assistance with documentation and compliance for CE marking under European medical device regulations.

Regulatory Compliance & Post-Approval Support

Guidance on regulatory updates, change notifications, and ongoing compliance requirements.

Brazil Regulatory Services (ANVISA)

Regulatory Compliance & Post-Approval Support

Brazil Regulatory Services (ANVISA)

Regulatory consultancy for Brazil medical device approval through ANVISA, including classification, dossier preparation, product registration, GMP compliance, and market authorization support.

About LUMBAR HEALTHTECH

Our Mission

At LUMBAR HEALTHTECH, our mission is to ensure the safe and effective use of medical devices. We strive to provide comprehensive regulatory solutions that empower manufacturers and importers to meet compliance standards set by the CDSCO.

About us

Lumbar Healthtech Pvt Ltd is a regulatory consulting company specializing in medical device regulatory compliance and market access. Based in Chennai, India, we support medical device manufacturers, importers, and distributors in navigating complex regulatory requirements.

Our services include regulatory guidance and licensing support for CDSCO approvals in India, USFDA regulatory pathways, and CE marking for European markets. We assist clients with product classification, technical documentation, regulatory submissions, and compliance strategies to ensure smooth and efficient approval processes.

With a strong understanding of global medical device regulations, Lumbar Healthtech is committed to providing reliable, accurate, and timely regulatory solutions. Our goal is to help healthcare companies bring safe, compliant, and high-quality medical devices to the market while meeting all regulatory standards.

We aim to be a trusted regulatory partner for organizations seeking professional support in the evolving medical device regulatory landscape.

Regulatory Markets (CDSCO / USFDA / CE / ANVISA)

Lumbar Healthtech Pvt Ltd provides regulatory consulting services to support medical device companies in obtaining approvals and maintaining compliance across major global regulatory markets. Our expertise helps manufacturers and importers navigate complex regulatory requirements efficiently.

India – Central Drugs Standard Control Organisation (CDSCO)

We assist with regulatory approvals for medical devices in India, including product classification, import licensing, manufacturing licenses, and preparation of technical documentation in accordance with CDSCO regulations.

United States – U.S. Food and Drug Administration (USFDA)

Our team supports regulatory pathways for the U.S. market, including device classification, 510(k) submissions, regulatory strategy, and compliance with applicable FDA requirements.

Europe – CE Marking for Medical Devices

We guide companies through the CE marking process under European medical device regulations, including technical documentation preparation, conformity assessment, and regulatory compliance for market entry.

Brazil – ANVISA Medical Device Registration

Regulatory consultancy for Brazil medical device approval through ANVISA, including classification, dossier preparation, product registration, GMP compliance, and market authorization support.

Medical Device & Cosmetics Regulatory Solutions

Global Regulatory Expertise

INDIA - CDSCO

UNITED STATES - US FDA

UNITED STATES - US FDA

UNITED STATES - US FDA

UNITED STATES - US FDA

UNITED STATES - US FDA

EUROPEAN UNION - EU Regulatory

EUROPEAN UNION - EU Regulatory

EUROPEAN UNION - EU Regulatory

BRAZIL-ANVISA

EUROPEAN UNION - EU Regulatory

EUROPEAN UNION - EU Regulatory

Key Steps for Medical Device Registration in India (CDSCO)

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

CDSCO Manufacturing License — Medical Device Manufacturing in India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

What is a CDSCO Manufacturing License?

Who Needs This License?

Types of Manufacturing Licenses

CDSCO Import License — Medical Device Import in India

Overview of the Medical Device Licensing Process under CDSCO (MDR-2017), India

CDSCO Import License — Medical Device Import in India

What is a CDSCO Import License?

Who Needs This License?

Types of Import Licenses

OUR SERVICES

CDSCO Medical Device Registration

CDSCO Medical Device Registration

CDSCO Medical Device Registration

Import License Assistance

CDSCO Medical Device Registration

CDSCO Medical Device Registration

Manufacturing License Support

CDSCO Medical Device Registration

Regulatory Strategy & Product Classification

Regulatory Strategy & Product Classification

Regulatory Strategy & Product Classification

Regulatory Strategy & Product Classification

Technical Documentation Preparation

Regulatory Strategy & Product Classification

Technical Documentation Preparation

USFDA Regulatory Consulting

Regulatory Strategy & Product Classification

Technical Documentation Preparation

CE Marking Support

Regulatory Compliance & Post-Approval Support

Regulatory Compliance & Post-Approval Support

Regulatory Compliance & Post-Approval Support

Regulatory Compliance & Post-Approval Support

Regulatory Compliance & Post-Approval Support

Brazil Regulatory Services (ANVISA)

Regulatory Compliance & Post-Approval Support

Brazil Regulatory Services (ANVISA)

About LUMBAR HEALTHTECH

Our Mission

About us

Regulatory Markets (CDSCO / USFDA / CE / ANVISA)

India – Central Drugs Standard Control Organisation (CDSCO)

United States – U.S. Food and Drug Administration (USFDA)

Europe – CE Marking for Medical Devices

Brazil – ANVISA Medical Device Registration

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Company Profile

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