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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.
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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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 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 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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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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CDSCO Registration: Process, Requirements, and Compliance Guide

  • CDSCO Registration is issued by the Central Drugs Standard Control Organization (regulatory body)
  • Covers drugs, cosmetics, and medical devices
  • Required for manufacturers, importers, and distributors
  • Applied online via SUGAM Portal
  • Documents: application form, product details, manufacturing license, GMP/ISO, fees
  • Timeline: 4–12 weeks for approval
  • Mandatory for selling or marketing regulated products in India
  • Ensures compliance, safety, and consumer trust

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overview

what is CDSCO registration and its role?

The Central Drugs Standard Control Organization (CDSCO Registration) is the national regulatory authority for pharmaceutical and medical devices in India. Operating under the Ministry of Health and Family Welfare, CDSCO is responsible for ensuring the safety, efficacy, and quality of drugs and medical devices sold in the Indian market. In this article, we will explore the process and importance of CDSCO registration for medical devices and pharmaceuticals, with insights based on expertise from Diligence Certifications.

CDSCO registration refers to the approval process administered by the Central Drugs Standard Control Organization (CDSCO Registration) to authorize the sale, distribution, and manufacture of medical devices and pharmaceutical products in India. This process is mandatory for companies seeking to enter the Indian market and ensures that the products meet regulatory standards established by CDSCO.

importance of CDSCO registration

For pharmaceutical and medical device companies, CDSCO Registration is essential for several reasons:

  1. Regulatory Compliance: By registering with CDSCO, manufacturers comply with Indian regulations concerning the safety, effectiveness, and quality of drugs and medical devices.
  2. Market Entry: CDSCO serves as a prerequisite for marketing products in India. Without registration, it is illegal to distribute or sell pharmaceutical products or medical devices.
  3. Consumer Safety: The registration ensures that products are safe for use, reducing risks associated with substandard or counterfeit products entering the market.
  4. Credibility and Trust: Achieving CDSCO approval enhances a company’s credibility, fostering trust among healthcare professionals and consumers.

Challenges in CDSCO registration

While CDSCO registration is crucial, the process can be challenging for companies due to:

  • Compliance Complexity: Adhering to India’s regulatory requirements can be difficult for companies unfamiliar with the local laws.
  • Documentation Requirements: The registration process involves extensive documentation, which can be time-consuming and requires high accuracy.
  • Time-Consuming Approval Process: The review and approval process can sometimes take months, leading to delays in market entry.

How to Overcome Challenges in CDSCO Registration?

To navigate the complexities of CDSCO registration, companies can take the following steps:

Hire Regulatory Experts: Consulting with regulatory affairs experts or hiring experienced consultants can help streamline the application process. Ensure High-Quality Documentation Properly preparing all required documents and ensuring they meet CDSCO’s standards can reduce delays. Stay Updated with changes in CDSCO regulations, as they may evolve over time and affect the registration process.

Types of CDSCO Registration

CDSCO is required for a wide range of products, including but not limited to:

Pharmaceuticals: Prescription and over-the-counter drugs, vaccines, blood products, and other biologicals.

Medical Devices: Devices such as diagnostic tools, surgical instruments, implants, and diagnostic reagents.

Cosmetics: Certain cosmetic products may also require CDSCO registration depending on their ingredients and intended use.

Documentation

required documents along with registration application on CDSCO portal

CDSCO Certification
  • ID Proof Document
  • Undertaking issued by a Government Authority
  • Address Proof Document
  • Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration
  • Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration

Process

CDSCO Registration Procedure

CDSCO Registration

Classification of Medical Devices as per CDSCO Regulatory Guidelines The first step in the CDSCO registration process is to accurately classify the medical device. After classification, compile an application file with detailed information about the device, including its composition, formulation, manufacturing process, regulatory certificates, intended use, and any relevant clinical trial data.

Submission of Application on the CDSCO Portal

After preparing the application, it needs to be submitted online via the CDSCO portal along with the applicable fees. The CDSCO will then review the application and may request further information or clarifications if required.

CDSCO Review Process

Upon receiving the application, the CDSCO undertakes a thorough review to assess whether the drug or medical device is safe and effective for its intended purpose. This evaluation may involve analyzing all submitted data, performing site inspections, and consulting with domain experts.

Approval

Following the evaluation, the CDSCO will either approve the sale and distribution of the drug or medical device in India or reject the application if it fails to meet the necessary safety and efficacy criteria.

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Conclusion

CDSCO Registration is vital for pharmaceutical and medical device companies wishing to market their products in India. It ensures compliance with local regulatory requirements, supports product safety, and boosts credibility. Despite the challenges involved, businesses can successfully navigate the CDSCO Registration process with careful preparation, attention to detail, and expert guidance, such as from Diligence Certifications, which can offer invaluable assistance throughout the process.

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Frequently Asked Questions

A CDSCO License is an approval issued by the Central Drugs Standard Control Organization (CDSCO) for the manufacturing, import, distribution, or sale of drugs, medical devices, and cosmetics in India. It ensures compliance with Indian regulatory standards to maintain safety and quality.

Manufacturers, importers, distributors, and sellers of pharmaceuticals, medical devices, and cosmetics must obtain CDSCO registration before conducting business in India.

CDSCO issues various licenses, including:

  • Manufacturing License (for local production)
  • CDSCO Import Licence (for importing drugs/medical devices)
  • Wholesale Drug License
  • Retail Drug License
  • Cosmetics Registration License

A CDSCO Import Licence is a mandatory approval required for importing drugs, medical devices, or cosmetics into India. It ensures compliance with the Drugs and Cosmetics Act, 1940.

  • Key documents include:

    • Form 10 (Application for Import License)
    • Manufacturing License from the country of origin
    • Free Sale Certificate (FSC)
    • Test reports and product specifications
    • Importer authorization letter

Diligence Certification provides expert guidance for CDSCO License application, CDSCO Import Licence approval, compliance assistance, and renewal support, ensuring smooth regulatory approvals for your business.

CDSCO provides registration for:

  • Drugs & Pharmaceuticals (Form 41 & Form 10)
  • Medical Devices & IVD Kits (Form MD-15, MD-9)
  • Cosmetics Registration (Form COS-1)
  • Biological Products & Vaccines
  • Blood Banks & Stem Cell Therapy Approvals
  • CDSCO Registration is for approval of products to be sold in India.
  • CDSCO Import Licence is mandatory for importing approved drugs, medical devices, and cosmetics into India.

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