CDSCO Registration in India: Complete Guide for Medical Devices and Cosmetics




The Indian healthcare and cosmetic industries are flowering; manufacturers, producers, and marketers show heightened satisfaction toward safety, quality, and compliance. The apex institution is CDSCO in ensuring that medical devices and cosmetics sold in India or imported into the country meet the required safety and quality standards.

Assuming you are either a manufacturer of medical devices or an importer of cosmetics, there is a requirement that you register with the CDSCO. This guide describes the CDSCO Cosmetic Registration Process and briefly explains CDSCO Medical Device Registration and compliance with Indian laws.

Understanding CDSCO and Its Role

The CDSCO comes under the Ministry of Health and Family Welfare, Government of India. It regulates the approval of manufacture, importation, and sale of drugs, cosmetics, and medical devices in India.

The CDSCO ensures safety, performance, and quality before any medical device enters the Indian market. It also prevents any cosmetic from entering India that could compromise consumer health.

In short, CDSCO functions as the real gatekeeper for product safety and compliance in both medical devices and cosmetics in India.

Registration of Cosmetics with CDSCO

The Drugs and Cosmetics Act, 1940 and the Rules of 1945 mandate that a CDSCO Cosmetic Registration Certificate is required for importing or manufacturing cosmetic goods for sale in India.

Step 1: Determine Product Category

Cosmetic products include skin creams, lotions, shampoos, fragrances, nail polish, and makeup. Each product variant must be registered separately with the CDSCO.

Step 2: Prepare the Required Documents

Documents required for CDSCO Cosmetic Registration Process include:

  • Cover letter and application form (Form COS-1)
  • Power of Attorney (if an authorized agent is applying)
  • Free Sale Certificate from the country of origin (for imported products)
  • Ingredient list and specifications
  • Product testing reports and label artwork

Step 3: File the Application Online

The applicant (manufacturer or authorized Indian agent) must register via the CDSCO SUGAM online portal and submit all required documents along with the applicable government fee.

Step 4: Review and Approval

CDSCO reviews the application and may request clarifications or additional details. Once verified, a COS-CDS certificate is issued, completing the CDSCO Cosmetic Registration Process.

CDSCO Medical Device Registration

The CDSCO Medical Device Registration applies to any importer or manufacturer intending to deal with devices classified under the Medical Devices Rules, 2017. This includes diagnostic equipment, surgical instruments, implants, and monitoring devices.

Step 1: Device Classification

CDSCO classifies medical devices based on risk:

  • Class A – Low Risk (e.g., thermometers)
  • Class B – Low-Moderate Risk (e.g., needles)
  • Class C – Moderate-High Risk (e.g., ventilators)
  • Class D – High Risk (e.g., pacemakers)

Step 2: Appointing Authorized Indian Agent (For Imports)

Foreign manufacturers must appoint an authorized Indian representative to liaise with CDSCO and hold the registration certificate on behalf of the company.

Step 3: Preparing Documents

Required documents for CDSCO Medical Device Registration include:

  • ISO 13485 Certificate
  • Free Sale Certificate or Manufacturing License from home country
  • Device Master File (DMF) and Plant Master File (PMF)
  • Test reports, labels, and product specifications

Step 4: Submission via SUGAM Portal

All applications must be submitted online through the CDSCO SUGAM portal. The authority evaluates the safety, quality, and efficacy of the device.

Step 5: Grant of Registration Certificate

After approval, CDSCO issues the Registration Certificate in Form MD-15 or the Manufacturing License in Form MD-5/MD-9, depending on the device category and applicant type.

Importance of CDSCO Registration

  • Ensuring Legal Compliance: Mandatory for all regulated medical devices and cosmetic products.
  • Prevent Import/Distribution Delay: Products clear customs only if registered with CDSCO.
  • Build Brand Trust: Certification assures customers and healthcare professionals of product safety.
  • Promotes Global Acceptance: International recognition is enhanced with CDSCO registration.

Contact BR & Associates for LMPC Registration

BR & Associates
📍 Address: U-44A, Upadhyay Block, Shakarpur, Near Laxmi Nagar Metro Station, New Delhi - 110092
📞 Phone: +91-6299905141, +91-9310420570
✉ Email: info@brassociates.co.in
🌐 Website: www.brandassociates.co.in

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