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Get your products BIS certified to ensure compliance with Indian standards and build customer trust. We handle end-to-end certification, testing, and documentation for manufacturers,importers, and exporters.
Our expert guidance and support help you stay compliant and gain a competitive edge in the market — your satisfaction is our commitment
Our team simplifies the application process and provides tailored support to meet your EPR compliance requirements effectively.
Our expert guidance and complete support help you achieve LMPC Certification smoothly, giving your business a competitive edge and long-term credibility.
Our comprehensive support ensures smooth WPC compliance and gives your business a competitive edge while prioritizing your long-term success.
Global Approvals help your products meet international regulatory standards, allowing smooth entry into multiple global markets.
Our expert guidance and end-to-end support help you achieve TEC certification smoothly while gaining a competitive edge in the market.
With 25+ years of experience, we help you meet ARAI compliance smoothly and gain a competitive edge in the automotive market.
Struggling to secure BEE Certification in India? Our specialists make the process easy and help you boost customer trust through verified energy ratings.
ISO Certification guarantees your business meets global standards for quality, safety and efficiency.
Flying without proper registration or clearance can lead to fines, drone seizure, and legal action, making regulatory compliance essential for safe and lawful drone operations.
Our expert guidance ensures your steel imports meet Ministry of Steel and BIS standards, helping you stay compliant and streamline the approval process.
How to apply for BIS Certification in 5 Mins!

Apart from product certification, BIS is responsible for framing Indian Standards, conducting laboratory testing, and ensuring consumer protection.

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How to apply for ISI Certification in 5 Mins!

Some items must be certified before they get released mysteriously made for select goods like cables, switches, cement, gas cylinders, etc.

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CRS Certification- A Complete Guide for Electronic Product Compliance in India

It ensures electronic products conform to Indian Standards (IS).Covers 70+ products including laptops, phones, adapters, TVs, and batteries.

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Hallmarking Certification- Everything You Must Know About Gold and Silver Purity Compliance

Hallmarking Certification is mandatory in India for gold and silver jewellery.The BIS 916 Hallmark confirms 22K gold purity.Silver Hallmarking is compulsory for certain grades like BIS 925.

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FMCS Mark Certification- A Guide for Global Brands Selling in India

FMCS Mark Certification is a BIS-led approval process that enables foreign manufacturers to sell regulated products in the Indian market.

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ECO Mark Certification : Your Complete Guide to Global Eco-Labeling Standards

It helps manufacturers build trust and create a compliance framework. It also markets to eco-conscious consumers.This guide will detail eligibility, provide information on the application procedure, and outline benefits of certification to ISO 14024.

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Finding Laboratory Accreditation Tough? We Make It Simple!

It is governed by NABL under the Quality Council of India (QCI).Accreditation enhances trust among regulators, industries, and global partners.

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World Manufacturer Identity (WMI) Registration

The World Manufacturer Identity (WMI) is a globally recognized code used to identify vehicle manufacturers. WMI registration ensures traceability, compliance, and global brand recognition for automotive makers.

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BIS Scheme X Certification - Process, Documentation and Fees Structure- Updated Guide 2025-2026

Stay ahead of regulatory changes with BIS Scheme X Certification. Now extended to September 1, 2026, under the omnibus technical regulation order 2024. Get complete certification support from Diligence Certification.

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Get your CDSCO registration

Get full assistance for CDSCO registration, medical device import licenses, and cosmetic import licenses with Diligence Certifications. Our expert guidance and comprehensive support ensure your compliance, helping you gain a competitive edge in the market. Your satisfaction is our commitment!

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Drug License

Diligence Certifications is a top-tier name in drug licensing and provides topmost service and knowledge support to all sizes of pharmaceutical companies. Our seasoned team understands the global regulations and has seen several success stories.

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Give Your Products cosmetic license

Having trouble securing Cosmetic License certification in India? Let our ISI certification experts assist you in achieving it and boosting your credibility!

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Give Your Medical device Registration

Get expert guidance on Medical Device Registration in India. Learn CDSCO approval process, documents, fees & compliance for manufacturers and importers.

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Obtain Your CPCB Certification Effortlessly………

Secure your CPCB Certification with ease and align your business with environmental regulations and sustainable practices. Our expert team streamlines the application process, offering tailored guidance to meet your unique EPR compliance requirements.

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Get battery waste Compliance Certification for Your Products

Need assistance in Battery Waste Certification? Our experts guide you through every step to ensure smooth and compliant processing.

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EPR Registration for E-Waste Certification

E-waste has become one of the most serious problems of the modern world, as technology is changing very fast. Discarded electronics items such as smartphones and refrigerators contain very toxic elements hazardous to human health and the environment if not treated properly.

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EPR for Tyre Waste – Tyre Waste Management Guide

Tyre wastage is an increasing global problem. It threatens to engulf the world in a sea of rubber with disastrous consequences for the environment and human health.

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Get Plastic waste Compliance Certification for Your Products

Diligence Certifications help businesses go a long way in environmental compliance matters through their management of plastic waste compliance. It rallies your commitment to reducing environmental impacts, increasing your recycling, driving circular economies and, hence, building credibility with consumers as citizens of a wider world contending against plastic pollution with angels and regulators.

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EPR Registration for USED OIL in India

Having trouble in getting EPR registration for your oil products in India? Let the experts do it for you and give credence to your products!

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Get No Objection Certificate for Your Business

The No-Objection Certificate has special relevance for a business; from needing it while applying for a loan, selling property, or for an application to pursue higher education, there are multiple situations where one has to face the need for an NOC.

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Get Your LMPC Certification!

Get Full Assistance for Model Approval for Indian W&M Instruments and Importer Registration for Weight and Measurement Instruments with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your LMPC Certification needs, helping you gain a competitive edge in the market. Your satisfaction is our commitment, and we work tirelessly to ensure it, now and in the future.

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Get Your LMPC Certification for Packaged Commodities

The Diligence Certifications for Packaged Commodities Certification ensures the product conformity with the regulatory requirements. It assesses your product labeling, weight, and quality for compliance with legal requirements and gives transparency and consumer trust. This certification is an instrument of defense against wrong packaging for business and consumers alike and shows your commitment toward fair trading practices and market integrity.

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Get Your LMPC Import License Certification!

Diligence Certifications offers provision of LMPC Import License Certification under Legal Metrology Packaged Commodities rules with respect to process of importation of goods into India for compliance. Our proficiency ensures that your labeling and packaging for products meet the requirements for easy clearance of goods through customs. It certifies approval from the regulators, having legal backing and gaining confidence of consumers and authorities.

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Legal Metrology Certification for Weights and Measures

The legal metrology certification is gaining importance in today’s ever-changing context of business with emphasis on fair trade and consumer protection. There is a fresh perspective on maintaining the true measurement and weighing-related activities on account of the fact that with almost every passing day, market growth and transaction complications are assuming greater magnitude.

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Get Your LMPC Manufacturer Registration

The company is authorized to undertake the LMPC Manufacturer Registration if it manufactures weights and measures within India. This registration under the Legal Metrology Act guarantees fair and correct transaction laws for business and trade activities through LMPC certificate registration. Let us demystify all the information you would require below.

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Get Your WPC Approval!

Get Full Assistance for Non-Network License, Network License, and Equipment Type Approval with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your WPC Approval needs, helping you gain a competitive edge in the market. Your satisfaction is our commitment, and we work tirelessly to ensure it, now and in the future.

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Get Your WPC Import License Certification!

The Diligence Certifications grant a fast track to the acquisition of WPC Import License, making the imports of communication devices 100% compliant with WPC Certification. Based on our experience and expertise, we ready you for the licensing processes in such a way that your product conforms with all technical standards and is safely usable within India. The certification would guarantee acceptance by regulators, therefore cultivating such trust with the authorities and end users.

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DPL/NDPL Certification: Ensuring Safety and Compliance for Your Wireless Products

Today-connected world, indeed, keeps the promise of wireless devices. Today manufactured devices include laptops, smartphones, portable WiFi hotspots, WiFi extenders, and smart home appliances. However, with this pressing usage, there is a huge demand for safety and performance requirements.

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Equipment Type Approval (ETA) for Wireless Devices in India

In this hyper-connected age, wireless access points, portable Wi-Fi routers, and other radio frequency (RF) devices are indispensable. When any of these products are manufactured, imported, or sold in India, the knowledge of and acquiring Equipment Type Approval (ETA) becomes imperative; that’s how Diligence Certifications will help you obtain your WPC Certification more conveniently.

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Get Your RoHS Certification!

In today’s world with increasing environmental consciousness, it is vital to dispose of equipment properly after the intended lifetime. Targeting hazardous e-waste is one of the vital roles played by RoHS; elaborately explaining RoHS certification itself, RoHS objectives, substances involved, certification processes, and applicability in curbing environmental contamination.

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Get Your UL Certification

Diligence Certifications provides UL (Underwriters Laboratories) Certification services to ensure your products comply with rigorous safety and performance standards. Our skilled team supports you throughout the certification process, ensuring full adherence to UL requirements. Achieving UL certification with us boosts your product’s credibility, fosters consumer confidence, and highlights your dedication to safety and quality in the market.

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Give Your Products KC Certification

KC Certification is a major mandatory condition for many products that are developed to reach Korea’s genuine profitable consuming market. KC Certification is otherwise known as KC Registration or simply the Korean Certificate, and denotes compliance with Korean safety standards and regulations.

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Give Your Products FCC Certification

Struggling with FCC certification in India? Our expert team at Diligence Certifications can help you navigate the process effortlessly, ensuring your electronic devices meet all compliance standards. Boost your credibility and market access with FCC certification today!

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Give Your Products CE Certification

Among these is the CE Marking, which is especially pertinent to manufacturers who are considering selling their products in the European Economic Area (EEA).

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SAFTA Certificate: A Complete Compliance Guide for Indian Exporters

The SAFTA certificate online enables reduced customs duties under the SAARC trade agreement.Businesses can apply for a SAFTA certificate digitally through authorised agencies in India.This document is vital for proving origin and unlocking tariff benefits.

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MSDS Certificate for Hazardous Chemicals and Hazardous Products

You can apply online for your MSDS Certificate in India through many trusted compliance and safety services.This documentation allows the company to maintain regulatory safety and hazard management which also protects the world you operate in.

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SASO Certificate Of Conformity For Export to Saudi Arabia

SALEEM / SABER system is the online conformity platform linking exporters, certification bodies, and customs.Two stages: Product CoC (PCoC, valid one year) and Shipment CoC (SCoC, per consignment).

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Get UKCA Certification in India | Expert UKCA Marking Guide

It replaces the CE marking post-Brexit and is mandatory for most regulated products.Indian manufacturers exporting to the UK need UKCA marking to stay compliant.

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Get Your TEC Approval!

Get Full Assistance for TEC Type Approval, TEC Interface Approval, TEC Certification Approval and TEC Approval of Technology with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your TEC Approval needs, helping you gain a competitive edge in the telecommunications market. Your satisfaction is our commitment, and we are dedicated to ensuring it now and in the future.

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Get ARAI Vehicle Certification!

Get full assistance for ARAI Vehicle Certification for vehicles, engines, and components with Diligence Certifications. With over 25 years of experience, we prioritize your success in gaining a competitive edge in the automotive market. Trust our expert guidance for all your ARAI certification needs.

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Give Your Products BEE Star Rating Certification

Having trouble securing BEE Star Rating Certification in India? Let our ISI certification experts assist you in achieving it and boosting your credibility!

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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Get ISO Certification for Your Business – Ensure Quality and Global Compliance

It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.

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End-to-end certification and regulatory compliance for Indian and global markets.

Register your business with ease and stay compliant with Indian regulations. We take care of end-to-end documentation, approvals, and legal formalities for startups, MSMEs, and enterprises.
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One-Person Company: Your Business, Your Control, with Limited Liability Protection!

Diligence Certifications streamlines the One-Person Company (OPC Registration in India) registration process, ensuring compliance with all.

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Give Your Products FIRM Registration.

Starting a business is an exciting venture, and choosing the right legal structure is a crucial first step. For many entrepreneurs, a partnership firm offers a flexible and collaborative way to operate.

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Startup India Registration.

Unlock the exclusive benefits and enhance the startup with Startup India Registration – along with that Diligence Certifications can help you with the whole process and ensure that every requirement is fulfilled for a successful Startup India Registration in India.

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Get your Organization NGO registration.

Are you really into making a difference or starting your own Non-Governmental Organization (NGO Registration) in India? We will also mention how Diligence Certifications can assist you in such cases.

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PESO License: Safety and Excellence in Material.

The PESO License framework establishes mandatory approval processes for products relevant to the oil and gas sector, particularly those involved in gas handling or intended for use in corrosive environments prevalent in the industry.

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Empower Your Indian Subsidiary Company Registration.

Our expert team provides comprehensive guidance through each step, from documentation to application submission. With our assistance, you can establish your subsidiary efficiently, gain legal recognition, and leverage opportunities for growth in the Indian market.

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Producer Company Registration: Empowering Farmers Through Collective Strength.

The Producer Company Registration offers this sort of power to farmers to organize and run businesses for their mutual benefit collectively.How Diligence Certifications can facilitate the process with credibility for a Farmer Producer Company (FPC).

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Empowering Independent Business with Seamless Sole Proprietorship Registration.

It offers a straightforward setup and direct control, making it the most popular and straightforward business structure in India.

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Ensure Your Shop and Establishment Registration.

Setting up a new enterprise should be exciting, even though there are deterrents in legal implications. That is a journey almost every business-making entity undertakes, from the littlest to the largest-the Shop and Establishment Registration.

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Ensure your MSME registration.

Our expert team provides comprehensive support throughout the registration process, from documentation to application submission. With our assistance, you can access government benefits, secure funding opportunities, and enhance your business credibility in the competitive market.

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Give Your Products FSSAI Mark Certification.

FSSAI mark certification is an important regulatory mechanism that guarantees strict adherence to food safety and quality standards by all food products manufactured, imported, and sold in India.

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PSARA (Private Security Agencies Regulation Act) License.

No longer complicated definitions for you; just straight, simple, useful information that will get your business going.

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Medical Devices Registration Process for Manufacturers & Importers

  • The Medical Device Registration is governed by CDSCO under the Drugs & Cosmetics Act.
  • Medical device registration provides safety, quality, and compliance before medical devices enter the Indian market.
  • Any manufacturer, importer, or distributor of medical devices must obtain CDSCO Medical Device Registration.
  • The registration process involves a collection of documents, CDSCO forms, fees, and timeframes for approval.
  • Diligence Certifications can make Medical Device Registration easier for you and help you avoid expensive mistakes.
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Introduction

Medical Device Registration in India

What is Medical Device Registration?

CDSCO Medical Device Manufacturing License

Advantage

Documents

Process

Forms

Renewal

Timeline

Why choose Diligence Certification for ISI Mark Certification?

CDSCO Medical Device Registration – An Overview

CDSCO Medical Device Registration is a requirement mandated by law, as intended for an entity in the business of medical devices in India. The Central Drugs Standard Control Organization (CDSCO) leads the Ministry of Health & Family Welfare as the national authority developing guidelines, registration, approval, regulation and supervision of drugs, pharmaceuticals, medical and diagnosis devices. 

The healthcare industry in India is valued at $200 billion (March 2023), and is projected to reach $370 billion by 2025. Many opportunities exist there, but if you want to access this marketplace, CDSCO registration is required. 

Previously, just 15 types of devices were regulated by CDSCO, therefore the market was already much larger than that. History has shown that foreign med-tech brands used this to access the market, and establish control without regard to or they didn’t have any proper forms of regulation. Now CDSCO has all types of devices that at least should be used, specifically basic standards should originate to global compliance standards used for regulated medical device situations, in an India context.

Medical Device Registration

Medical Device Registration in India

The Central Drugs Standard Control Organization (CDSCO), as the national regulatory authority of India, is responsible for the regulation of pharmaceuticals, in-vitro diagnostics (IVDs), and medical devices. The CDSCO works as an arm of the Drug Controller General of India (DCGI), which regulates medical products and ensures that medical products have met requirements related to safety, efficiency, and quality (including importation regulations).

For this reason we require Medical Device manufacturers and importers to register with CDSCO. This is more than just checking the box as a regulatory requirement for compliance, instead it is required to build credibility and regulate with compliance in a growing healthcare market in India. 

The expected value of India’s healthcare industry is $200 billion (2023) and be $370 billion by 2025. Along with more than 900 pharmaceutical manufacturers in India who turn this into the world’s fourth manufacturer of pharmaceuticals makes compliance even more vital .

What is Medical Device Registration?

Medical Device Registration is the regulatory process that grants manufacturers and importers the legal authority to sell, distribute, or manufacture medical devices legally in India. 

This process also provides the assurance that medical devices that are authorized for sale in India have been evaluated to include safety, efficiency, and quality standards. The regulatory process includes classification, documentation, submission, review and approval. 

The CDSCO registration process protects patients from non-compliant devices and maintains and safeguards India to be comparable to global standards to protect medical device safety and efficaciousness in their treatment.

CDSCO Medical Device Manufacturing License

For Indian manufacturers, applying for and holding a Medical Device Manufacturing License is mandatory. Without this license, it is illegal to manufacture and sell your medical device in India.

Approval authority classifications:

  • Class A&B Devices (Low-to-Medium Risk): License is issued by the State Licensing Authority (SLA).
  • Class C&D Devices (Moderate-to-High Risk): License issued by the Central Licensing Authority (CLA) under the DCGI.

You can think of it as a driving license – even if you had the best car (your device), without the right CDSCO license, you cannot drive it on Indian roads.

Advantages of Having a CDSCO Import License for Medical Devices

Obtaining a CDSCO import license is an important step for any manufacturer or importer of medical devices before they can enter the Indian market. Not only is it a regulatory requirement, but the import license also has several strategic benefits for your business and brand image.

Key Benefits of a CDSCO Import License

1. Market Access A CDSCO Import license provides manufacturers and importers legal access to sell and distribute medical devices across India. Since India is one of the largest and growing markets for healthcare around the world, there are great opportunities for growth as well as the prospect of doing business.  2. Improved Brand Credibility This license serves as evidence that you are meeting India’s safety, efficacy and quality requirements. It shows that your organization is committed to reliable medical devices, improves your brand credibility and improves trust between you and your stakeholders, healthcare delivery organizations and their patients.  3. Regulatory Compliance The CDSCO import license will help to ensure that your products are compliant to the Medical Device Rules (MDR), Good Manufacturing Practices (GMP) and other Indian regulatory requirements. Following the Indian medical device framework will put you in a better place to avoid compliance and regulatory issues and enhance confidence in your device and in stakeholders with products in legitimate compliance to the Indian Medical Device Rules (MDR) personally and their products overall. 4. Competitive Advantage A valid license positions you in bulk against non-compliant manufacturing with clear advantages in tenders and tenders need CDSCO registered devices prior to awards in both public and private sector procurements which makes it a significant competitive advantage. Ultimately, there could be partnerships with high-value partners for just in time supply for cross-border procurement. 

Requirements for CDSCO Medical Device Registration in India

To complete the process of obtaining CDSCO registration, the applicants must meet the following requirements:

  • Compliance with Indian laws relating to medical devices
  • Providing comprehensive information about the manufacturing facility
  • Providing recent regulatory certificates as applicable, including:
  • European CE Certificate
  • Free Sale Certificate
  • ISO 13485 Certification
  • Labeling and packaging in compliance with Indian regulations
  • Payment of CDSCO registration fees as applicable.

Documents Required for Medical Device Registration

To apply for CDSCO medical device registration, the following documents are typically required:

  • ISO 13485 Certificate
  • Full Quality Assurance Certificate
  • CE Design Certificate
  • Power of attorney
  • Free Sale Certificate
  • Plant Master File (PMF)
  • Device Master File (DMF)
  • PMS Surveillance details

Purpose of CDSCO Certification

The main purpose of CDSCO certification is to ensure that medical devices and IVDs meet the proper safety, quality, and performance standards prior to being marketed in India. The certification process requires a thorough evaluation of: 

  • Device design and specifications 
  • Manufacturing practices 
  • Quality management practices 
  • Performance and safety data 

Overall, this ensures that devices available to healthcare providers and patients are safe reliable, and effective.

CDSCO Certification Process for Medical Devices

The CDSCO certification process is systematic and includes the following steps:

Step 1: Classify Medical Devices

The first stage requires identifying the proper classification according to risk level. You will also need to provide information on the medical device’s composition, manufacturing procedure, regulatory certificates, intended use of the device, and clinical trial data if available.

Step 2: Submit Application

The next step is to fill out the application and submit it online through the CDSCO portal with the applicable fees.

Step 3: CDSCO Review

The authorities then review your application and audit the manufacturing facility if required. The authorities may also seek expert opinion or consult with experts to determine the safety and efficacy of the medical device before granting the license.

Step 4: Approval/Rejection

When the medical device is found to be compliant, an approval is granted to market and sell the medical device in India. Otherwise CDSCO has the option to reject the medical device or ask you to provide clarifications.

Classification of Medical Devices under CDSCO

Medical devices are classified into four risk classes: 

  • Class A- A low risk device, for example stethoscope, bandage, thermometer.
  • Class B- A low to moderate risk device, for example syringes, and blood pressure monitors.
  • Class C- A moderate to high risk device, for example orthopedic implants and catheters.
  • Class D- A high risk device, for example pacemakers, ventilators and heart-lung machines.

CDSCO Import License Registration Process

For imported medical devices, an import license is mandatory.

Key Points:

  • From Oct 1, 2022: All Class A & B devices + notified Class C & D devices require an import license.
  • From Oct 1, 2023: Licensing extended to non-notified Class C & D devices as well.

Application Process:

  1. Documentation – Prepare regulatory certificates, QMS proof, and device specifications.
  2. Submission – Apply online via the CDSCO portal and upload required documents.
  3. Fees – Pay the prescribed application fees.
  4. Review & Approval – CDSCO verifies documents and issues the import license.

CDSCO Forms for Medical Device Registration

For Existing Devices:

  • MD-14 / MD-15 – Importer license (Class A–D devices)
  • MD-3 / MD-5 – Manufacturer’s license (Class A & B devices)
  • MD-4 / MD-6 – Loan license (Class A & B devices)
  • MD-7 / MD-9 – Manufacturer’s license (Class C & D devices)
  • MD-8 / MD-10 – Loan license (Class C & D devices)

Renewal of CDSCO Medical Device Manufacturing License

  • Licenses must be renewed at least 9 months before expiry.
  • Renewal requires submission of the Plant Master File (PMF) and MDevice Master File (DMF) to confirm no significant changes have been made.

Post-Compliance Requirements

After obtaining registration:

  • Inform CDSCO if there are changes in company constitution, registered office, or manufacturing site.
  • If changes occur in the registration certificate, it remains valid for 3 months only, during which an updated registration must be secured.

Recent CDSCO Update

As per the latest CDSCO notification, all medical devices require mandatory registration for import and sale in India effective October 1, 2023.

Timeline And Validity

  • Processing time: 6–9 months
  • Validity: 5 years from issue (unless suspended/revoked)

Offerings by Our CDSCO Medical Device License Consultants

Our consultants provide end-to-end support for CDSCO medical device registration, ensuring compliance with Indian regulatory standards.

 Key Services We Offer:

  • Medical Device Classification & Grouping Strategy
  • Regulatory Intelligence & Due Diligence in India
  • Indian Authorized Agent (IAA) Representation
  • Listing of Non-regulated Medical Devices
  • Manufacturing License for Regulated Devices & IVDs
  • Loan License Assistance for Regulated Devices & IVDs
  • Liaison with CDSCO, Central & State Licensing Authorities
  • In-country Testing Services
  • Manufacturing Site Registration
  • Test License for Medical Devices & IVDs
  • Post-market Surveillance & Compliance Support
  • AERB Approval for Radiation Diagnostic Equipment

Why Choose Diligence Certifications for CDSCO Registration?

Diligence Certifications is a leading CDSCO Medical Device License Consultant with a proven track record of helping med-tech businesses achieve regulatory compliance seamlessly.

 Why Industry Leaders Trust Us:

  • 10+ Years of Expertise in CDSCO Medical Device Registration
  • Timely Approvals with complete online registration support
  • Expert Device Classification Guidance
  • Successfully Registered Medical Devices for 100+ Clients
  • Preferred Consultant for top med-tech companies in India
  • Compliance Assurance to minimize risks and delays
  • End-to-End Assistance for manufacturing, import, and licensing requirements
  • PAN India Coverage to serve clients across all states

Contact Our Experts

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Frequently Asked Questions

Yes, all medical devices must be registered with CDSCO, by October 1, 2023.    

Usually, 6–9 months.  The timeline can vary based on the device type and level of documentation.   

CDSCO registration is valid for three years unless revoked or suspended.        

Domestic manufacturers, importers, foreign manufacturer, authorized agents, or Indian subsidiaries. 

CDSCO approves and licenses medical devices, drugs, and IVDs, and incurs investigational obligations.      

These are distinct risk based categories: Class A (Least Risk) to Class D (Highest Risk).

Yes, foreign manufacturers can apply directly or through Indian Authorized Agents (IAA) or their Indian subsidiary. 

 For some of the devices, this is also mandatory for quality and safety. 

The SUGAM portal is the official online portal for CDSCO application submission. 

No, unregistered devices cannot legally be sold or distributed in India.

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