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

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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.
DGCA Certification Process in India covers drone approval, UIN, RPC, Type Certificate, registration, costs, and complete compliance guidelines.
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
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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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CB Certification—Your Gateway to Global Product Compliance

CB stands for Certification Bodies Scheme.An international system operated by IECEE (IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components).Facilitates mutual recognition of test results among participating countries.Enables global market access for electrical and electronic products.Reduces the need for multiple testing and certification in different countries.

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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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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 Your Drone Registered in India—Effortlessly and Compliantly

Drones above nano size must be registered on Digital Sky and obtain a UIN, Type Certificate, remote-pilot certificate (for commercial use), and insurance—while adhering to airspace rules and NPNT protocol.

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Obtain Your No Objection Certificate (NOC) for Steel Importers with Ease

Importing steel into India? Get your No Objection Certificate (NOC) under the Steel Quality Control Order (QCO) without delays or compliance risks. Diligence Certifications offers complete support for steel importers—ensuring your products meet Ministry of Steel and BIS regulations, and helping you avoid customs issues, rejections, or penalties. Stay legally compliant, save time, and streamline your steel import process with our expert certification services.

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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.
Getting your business Public Limited Company Registration

In addition, you will be briefed on how Limited Liability Incorporation protects you and how Diligence Certifications may assist one in navigating the certification process.

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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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Get Your Business Legally Recognized with LLP Registration.

Starting a Limited Liability Partnership (LLP) can be a strategic move for entrepreneurs looking to combine the benefits of a partnership with the advantages of limited liability partnership.

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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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GEM Registration Services – Get Your Business Listed on the Government e-Marketplace.

The registration process begins with gathering mandatory documents such as PAN, GST, bank details, and Aadhaar/DSC.

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Private Limited Company Registration in India.

Well, at this point, are you really ready to take it to the next level? The formation of Private Limited Company Registration in India is often considered to be a strategic alternative by most entrepreneurs since it provides credibility combined with a limited liability and a scope for future investments:

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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 partnership firm registration.

With our assistance, you can establish your partnership with confidence, define roles and responsibilities, and set the foundation for successful collaboration.

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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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CDSCO Import License for Drugs, Cosmetics & Medical Devices – Requirements & Process

  • CDSCO Import License: Expert assistance for drugs, cosmetics, and medical devices.
  • Application Support: Help with Form 10A and compliance documents.
  • Regulatory Guidance: Ensure adherence to Drugs and Cosmetics Act, 1940.
  • License Renewal & Amendment: Hassle-free updates and modifications.
  • Customs Clearance Support: Avoid shipment delays with smooth approvals.
  • Startup & Importer Solutions: Personalized services for businesses of all sizes.

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Importance of CDSCO Import License

Documents for CDSCO Import License

Application Process for CDSCO License

why choose us?

Introduction

If you are a business or individual wishing to import drugs, cosmetics, and medical devices into India, a CDSCO Import License is a mandatory regulatory requirement. The Central Drugs Standard Control Organization (CDSCO), the statutory authority under the Drugs and Cosmetics Act, 1940, issues such a license to import drugs, cosmetics, and medical devices for the purpose of ensuring quality, safety, and regulatory standard compliance according to Indian regulations.

If you are a manufacturer, distributor, or startup, getting a CDSCO Import License is critical for importing legally, avoiding customs complications, and being compliant with government regulations. Our services will make the entire process easier, from the submission of the application to the inspection process, quickly and without headaches, and in total compliance.

What is CDSCO Certification?

CDSCO Certification is an official authorization issued by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory authority under the Ministry of Health and Family Welfare, Government of India, to ascertain that drugs, cosmetics and medical devices that are imported, manufactured and sold in India are of the required quality, safe, and efficacious.

Obtaining CDSCO Certification is a requisite for companies looking to import, manufacture and/or market healthcare-related products in India, and provides:

  • Preventing the spread of substandard or unsafe products.
  • Compliance with the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017.
  • Legal permission to sell or distribute products in the Indian-owned market.

What is the CDSCO import license?

A CDSCO-import license is basically a pass issued by the CDSCO for importing specified pharmaceuticals, medical devices import license, cosmetics, and other similar products for sale, distribution, or for any other commercial purpose. The process is very tedious as it involves the safety, efficacy, and quality of the imported product and ultimately protects people’s health and well-being of the Indian populace.

The license sets out particulars including:

  • Importer: Name, address, registration particulars.
  • Product(s) being imported: Name, composition, and inner intended use thereof.
  • Manufacturer: Name and address of the manufacturing site.
  • Validity period: Generally, an up-to-date period requiring renewal upon expiry.
  • Conditions and limitations: Conditions that must be adhered to by the importer, such as conditions of storage, proper labeling, and measures for quality control.
CDSCO import License

CDSCO Import License Importance

There are a number of clear things that the CDSCO Import License reveals:

  • Legal compliance: In India, the import or regulated product without a valid CDSCO Import License is regarded as illegal, inviting penalties, in the form of heavy/fine, seizure, or prosecution against the product.
  • Market Access: These products cannot be sold or distributed in the Indian market without the license; thereby effectively blocking access to what otherwise might have been a lucrative customer base.
  • Quality Assurance: The entire licensing process ensures that products imported under its full jurisdiction comply with stringent quality requirements, thereby establishing safety and efficacy in intended use.
  • Guaranteed Patient Protection: The good international scrutiny very well guarantees that no low-quality, fake, or contaminated product heeds the Indian marketplace.
  • Reputation and Credibility: Obtaining and keeping a CDSCO Import License demonstrates the commitment to quality and regulatory compliance. Such can build the reputation and credibility of the firm to distributors, health care providers, and consumers alike.
  • Trust Building with Stakeholders: It ensures to the distributors, retailers, and health care practitioners that your products passed through the regulatory authority, therefore enlisting their trust in sourcing your products.
  • Logistics Smooth Sailing: It helps to ensure the customs clearance and freight transportation with no delay for imported products fulfilling all requirements to make possible timely delivery of these products into the market.

Types of CDSCO Import License

1. Drug Import Licenses

CDSCO regulates the import of drugs and pharmaceuticals for both commercial and non-commercial purposes.
 Types include:

Form 10 – License to Import Drugs for Sale or Distribution

  • Issued to importers who want to import drugs for commercial sale or distribution in India.
  • Must be obtained from the Drugs Controller General of India (DCGI).
  • Requires a valid Wholesale Drug License (Form 20B and 21B).

Form 10A – License to Import Drugs for Examination, Test, or Analysis

  • Used for research and development (R&D) purposes.
  • Allows import of small quantities of drugs for testing, analysis, or evaluation.

Form 11 – License to Import Drugs for Clinical Trials

  • Mandatory for importing drugs intended for clinical trials in India.
  • The importer must have clinical trial permission under Rule 33 of the Drugs and Cosmetics Rules, 1945.

Form 12 – License to Import Small Quantities for Personal Use

  • Issued to individuals for personal medical use, on the recommendation of a registered medical practitioner.

2. Cosmetic Import License

Covers personal care and beauty products.

  • Applies to manufacturers, marketers, and importers.
  • Common categories: skincare creams, shampoos, lipsticks, fragrances, hair colours.
  • Importers need Form COS-2.

3. Medical Devices Import Licenses

Under the Medical Device Rules, 2017, importers must obtain licenses depending on the classification of the medical device:

  • Important process for the manufacturers and/or importers of medical devices as required by the Medical Devices Rules, 2017. Devices are classified as Class A (low risk), Class B (Moderate risk), Class C (High risk) and Class D (Critical risk)

    Form MD-3: License to manufacture Class A and B devices

    Form MD-7: License to manufacture Class C and D devices

    Form MD-14/15: For import of medical devices

    Forms needed to be submitted included Device Master File (DMF), Plant Master File (PMF), ISO 13485 certification, clinical/performance evaluation reports, and labeling as compliant.

Implications for Foreign Business

Anyone who knows how to obtain his CDSCO Import License, together with the fate of success and prosperity for such a person, will tie himself up with the foreign manufacturer that someday shall target the Indian market. The following areas require evaluation:

  • Being Diligent with Planning Functions: Since the licensing process is very challenging and prolonged, it is advisable to initiate the licensing process further in advance than when looking to make investments in serious market strategies.
  • Keeping a Comprehensive Document Dossier: All documents are in country-requirements within the CDSCO. This will include all specifications relating to product specifications, production, quality control, and importer details.
  • Consulting Regulatory Experts: Connect with a party having resources with experienced regulatory consultants who are working on compliance with CDSCO. This way, they will provide essential guidance and support during licensing.
  • Compliance Post Approval: After issuing the license, ensure total compliance with all conditions and restrictions defined therein, including setting up audit and quality control procedures in your plans.
  • Being Aware of the Regulatory Changes: This fact does that because it makes it really necessary for the Indian pharmaceutical and medical devices regulations to be fast-moving. Make all possible efforts to be in tune with the changes or updates concerning CDSCO guidelines and requirements in this regard. 

Required Documentation for a CDSCO Import License

A clear and comprehensive documentation set must be compiled. Generally, these are:

  • Application form
  • Proof of legal entity registration
  • Product registration details from the country of origin
  • Manufacturing and quality control documents

Application Process for CDSCO Import License

The application procedure for CDSCO Import Licenses may be thought of as tedious and time-consuming, requiring careful preparation of several relevant documents online application submission while there may also be need for calling for further inquiry from the CDSCO. A systematic breakdown may be extended as follows:

  1. Preliminary assessment and preparation
  • Product classification: Correctly classify your product as a drug under the CDSCO, medical device, or cosmetic since this will determine the exact type of license needed.

Document Collecting: Collect your documents through the following means:

  • Manufacturing license: This is a current license for manufacture in the country of origin.
  • Certificate of pharmaceutical products: This is a statement from the regulatory authority of the country of origin certifying that the product is registered for sale there.
  • Free sale certificate: This is a certificate in regard to free sale of the product in the country of origin.
  • Stability data: Stability and shelf-life data of the product.
  • Product specifications: Specification Sheets state dosage and composition with adequate information on formulations and packaging.
  • Test reports: Certificates from accredited labs signifying product complying to quality specifications.
  • Site Master File: Detailed document describing the manufacturing facility.
  • Application form: Special form depending on type of your product (Form 10, 10A, 11, 12, 28, or 41).
  • Power of Attorney: Relating to appointing your representative in India to act on your behalf. Any relevant documents as per the requirement by CDSCO depending on the product. 

Diligence Certifications can easily act as your authorized Indian agent for the sake of easy communications and regulatory compliance support.

  1. Online Procedure for Application Submission
  • SUGAM portal registration: Register your Company at the CDSCO SUGAM portal. 
  • Application Form Completeness: Fill in the relevant online availability CDSCO Import License application form carefully. Any and all relevant data will be accurate and consistent with the actual documents supplied.
  • Upload Documents: Upload as prescribed.
  • Payment of Fees: Fees to be paid online.
  1. CDSCO Assessment and Queries
  • Application Scrutiny: The CDSCO will scrutinize the application and supporting documents.
  • Query Handling: Respond promptly since the CDSCO may require additional information or raise queries; remember that Diligence Certifications can assist you to address those queries well.
  1. Granting of License
  • Licensing: The import license shall be granted if CDSCO is satisfied with your application, together with the results of any inspections.
  • Validity of License: The period of validity of the license depends on the type of product and specific requirements.

Benefits of Working with Diligence Certifications for your CDSCO Import License

Diligence Certifications is one of the several leading regulatory consulting firms in India with the specialization in the area of CDSCO registration and licensing. With our full-provision regulatory services, which include consultation that will see you through every aspect related to CDSCO Import Licenses, from assessment to grant, we greatly enhance the chances for the approval due to our capabilities and experience while saving priceless time and resources.

Some of the manners Diligence Certifications will assist you:

  • Coordinated Assistance: A team of regulatory practitioners functions as one and is fully aware of all intricacies connected with CDSCO regulations and requirements. Diligence Certifications would provide crisp and clear guidance on each of the aspects in the process.
  • Documentation Assistance: We assist you in gathering all necessary documentation and ensuring that the documents are accurate, complete, and in conformity with CDSCO requirements.
  • Application Management: Diligence Certifications will manage all aspects of the submission process such as SUGAM registration, document upload, and fee payment.
  • Resolution of Queries: Our experts will help you to decode the questions raised by the CDSCO and shall reply immediately so as to reduce delays and maximize the chance for approval.
  • Inspection Support: We shall prepare you for the CDSCO inspections and accompany you during the inspection.
  • Post License Assistance: We assist you in maintaining CDSCO compliance even after your license has been granted.
  • Time and Cost Savings: The ability to streamline the application process saves us time and resources, which in turn allows you to focus on your core business interests.

CDSCO Import License: Fees, Timeline, Validity & Renewal

The Central Drugs Standard Control Organisation (CDSCO) administers the importation of cosmetics, drugs and medical devices for the protection of the health and safety of the public and in order to improve of the quality of the products – ensuring that safe, effective and high quality products are imported and made available in the Indian market.

Before importing products, every applicant should be aware of the fees, processing time, validity and renewal of all types of import licenses that are issued by CDSCO.

1. CDSCO Import License Fees

The import license fee depends on:

  • The type of product (Drug, Cosmetic, or Medical Device)
  • The number of variants or models
  • The number of manufacturing sites included in the applicationAll payments are made digitally through the payment portal, linked with the CDSCO platform.

Applicants must upload the fee receipt along with other supporting documents during submission.

2. CDSCO Import License Timeline

The approval timeline for CDSCO import licenses varies depending on product classification, document completeness, and internal review.
 On average, the approval process involves the following stages:

StageDescriptionEstimated Duration
Application ReviewPreliminary scrutiny of documents by CDSCOVaries by product category
Query ResolutionClarification or additional information requestedDepends on applicant response time
Technical EvaluationSafety, labeling, and compliance reviewBased on product complexity
Final ApprovalIssuance of license after verificationWithin standard regulatory timeframe

3. Validity of CDSCO Import License

The validity of the import license differs depending on the category of product:

License TypeApplicable FormLicense Validity
Drug Import LicenseForm 10 / 11Valid for a fixed period as prescribed by CDSCO
Cosmetic Import LicenseCOS 1/ COS 2Generally valid for a fixed tenure from the date of issue
Medical Device Import LicenseForm MD-14 / MD-15Valid for multiple years from issuance

4. Renewal Process for CDSCO Import License

The renewal process is mandatory to continue importing after the expiry of the existing license.
 Renewal can be completed online through the CDSCO Portal by following these steps:

Step-by-Step Renewal Process

  1. Login to the CDSCO Portal with your registered importer credentials.
  2. Select “Renewal” under the appropriate import license category.
  3. Upload updated documents, including:
    • Existing license copy
    • Renewal request letter
    • Updated product list (if applicable)
    • Latest fee payment receipt
  4. Submit the application online and monitor progress through the portal.
  5. Receive the renewed license in the same format upon approval.

5. Renewal Timeline and Compliance

To avoid any interruption in import activities, it’s recommended to apply for renewal well before the license expiry date.

License TypeRenewal Application PeriodRecommendation
Drug Import LicenseBefore license expiryApply at least 1–2 months prior
Cosmetic Import LicenseBefore license expiryApply 45 days in advance
Medical Device Import LicenseBefore license expiryApply 2–3 months prior

Why Choose Diligence Certifications for CDSCO Import License?

Getting an import license from the CDSCO for drugs, cosmetics and medical devices can be quite difficult and lengthy. There are strict regulations, abundant documentation and even digitized submission of forms, and minor deficiencies, inaccuracies or mistakes in the forms can lead to delays or rejection. This is where Diligence Certifications can help – we are your trusted partner to help you have a painless, smooth and compliant process for your import license. 

1. Expertise Across All Product Categories

We have extensive experience handling import licenses for drugs, cosmetics, and medical devices. Our experts help you:

  • Correctly classify your product
  • Identify the right CDSCO form and license type
  • Prepare documents specific to your product category

2. Complete Documentation Support

Proper documentation is the backbone of a successful application. Our team assists in:

  • Preparing product dossiers, master files, and compliance certificates
  • Drafting Power of Attorney and authorization letters
  • Ensuring all documents meet CDSCO’s digital submission standards

3. End-to-End Application Assistance

We handle the entire application process on your behalf:

  • Accurate form filling
  • Uploading digitally signed documents
  • Payment verification and submission
  • Tracking application status until license approval

4. Faster Approval & Risk Reduction

By working with us, you minimize common delays caused by:

  • Missing or incomplete documents
  • Misclassification of products
  • Delayed responses to CDSCO queries

Our structured approach ensures faster approval and reduces the risk of rejection.

5. Post-License Compliance & Renewal Support

Our services don’t stop at license issuance. We provide ongoing support for:

  • License renewal before expiry
  • Updates on regulatory changes
  • Record-keeping and compliance management

6. Trusted & Reliable Partner

With years of experience in regulatory approvals, Diligence Certifications is a trusted partner for importers in India and abroad.

  • Transparent, client-focused approach
  • Strong expertise in CDSCO regulations
  • Commitment to accuracy, compliance, and efficiency

Contact Our Experts

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Frequently Asked Questions

The CDSCO Import License is an authorization granted by the Central Drugs Standard Control Organization (CDSCO) and is required for importation into India of drugs, medical devices, and cosmetics.

A company or a private individual who would like to import drugs, cosmetics, or medical devices into India has to apply for a CDSCO Import License.

Form 10- For drug import by licensed wholesalers/manufacturers.

Form 15- For the import of cosmetics.

Forms MD-15/MD-16- For import of medical devices.

The process includes:

  • Registration on the CDSCO portal
  • Submission of the required documents
  • Application filing with prescribed fees
  • Review and approval by CDSCO

Some of the key documents are:

  • Manufacturing license (if applicable);
  • Free Sale Certificate issued by the country of origin;
  • Information regarding the product and labelling;
  • Information regarding the Authorized Indian Representative (AIR).

No, a foreign company appoints an Authorized Indian Representative (AIR) to apply on behalf of. 

Importing without a valid CDSCO license may result in confiscation of the product(s) along with heavy pecuniary penalties and legal actions as per the provisions of the Drugs and Cosmetics Act. 

Diligence Certification offers an expert consultation for CDSCO compliance in:

  • Application preparation and submission,
  • Assistance in documentation,
  • Liaison with CDSCO authorities, 
  • Comprehensive support to license approval.