How to Get CDSCO Registration: Process, Documents & Benefits

How to Get CDSCO Registration: Process, Documents & Benefits

Complete Guide to CDSCO Registration & Certification for Indian Businesses


The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for the approval, oversight, and quality control of drugs, medical devices, cosmetics, and diagnostics.


Any business involved in manufacturing, importing, selling, distributing, or testing medical products must obtain CDSCO Registration or CDSCO Certification before entering the Indian market. This regulatory framework ensures that only safe, effective, and high-quality products are made available to consumers.


What Is CDSCO Registration?

CDSCO Registration is the mandatory authorization required for companies dealing in drugs, medical devices, in-vitro diagnostic kits, blood products, and cosmetics. This registration ensures that the product meets Indian safety, quality, and performance standards. Depending on the product type, businesses may require:


CDSCO also categorizes medical devices into Class A, B, C, and D, based on risk level, and the compliance requirements vary accordingly.


What Is CDSCO Certification?

CDSCO Certification is a formal approval confirming that a product complies with standards established by the Drug and Cosmetic Act, 1940 and Medical Device Rules, 2017. This certification is essential for:


Without CDSCO Certification, a product cannot legally enter the Indian healthcare market.


Why Businesses Need CDSCO Compliance

India is a rapidly growing market for pharmaceuticals and medical devices. To ensure ethical practices, safety, and transparency, CDSCO mandates strict compliance. Businesses that obtain CDSCO Registration and Certification gain:


Compliance also enhances consumer trust, which is crucial in healthcare industries.


Role of a CDSCO Consultant

The CDSCO approval process can be complex due to legal requirements, technical documentation, testing procedures, and audits. Hiring a professional CDSCO Consultant makes the process faster, error-free, and compliant. A consultant helps with:


A qualified consultant ensures your registration or certification is completed without delays or rejections.


Read: Udyam Re-Registration: Keeping Your MSME Identity


CDSCO Registration Process (Step-by-Step)

Step 1: Product Classification

Identify whether your product is a drug, cosmetic, or medical device and determine its category or class.


Step 2: Documentation Preparation

Key documents include:


Step 3: Application Submission on SUGAM

All registrations are filed digitally through the CDSCO SUGAM Portal.


Step 4: Evaluation & Query Resolution

Authorities check documents and may request clarifications.


Step 5: Inspection & Testing

High-risk devices require clinical evaluation or third-party testing.


Step 6: Grant of Certificate

Once approved, the business receives the license or certificate, valid for a specific period.


Business Registration for CDSCO Operations

To obtain CDSCO Registration, the applicant must be a legally registered business in India. Common business structures include:

Business registration provides a legal identity and is mandatory for obtaining drug and medical device licenses.


Why Choose Professional CDSCO Consultation Services?

A professional consultant helps businesses avoid document errors, rejected applications, and long approval delays. They ensure:

This is especially important for startups, importers, and foreign manufacturers entering the Indian market.