CDSCO Medical Device Registration and Cosmetic Registration Process in India

 India's burgeoning healthcare and cosmetic markets have become hotbeds of activity. Local and international manufacturers are eager to enter this promising market with soaring consumer demand for high-quality medical devices and personal care items. However, compliance with regulations is of prime importance for ensuring safety, quality, and transparency. The Central Drugs Standard Control Organization (CDSCO) is the central authority governing approvals, licensing, and compliance with medical device and cosmetics standards in India.

For business expansion, CDSCO medical device registration and the CDSCO cosmetic registration process are mandatory. Below, we detail the procedures and their importance.

Importance of CDSCO for Medical Devices

The CDSCO, working under the Ministry of Health and Family Welfare, India, regulates the manufacture, import, and distribution of drugs, cosmetics, and medical devices. Its role ensures the safety, efficacy, and standardization of products, contributing to better public health.

Medical devices are classified according to risk:

  • Class A (Low risk)
  • Class B (Low-Moderate risk)
  • Class C (Moderate-High risk)
  • Class D (High risk)

A license from CDSCO is mandatory before medical devices can enter the Indian market. Without CDSCO registration for medical devices, products may face customs rejection, recalls, or penalties.

Process of CDSCO Medical Device Registration

The CDSCO has a structured process for approvals under the Medical Device Rules, 2017:

Step 1: Device Classification
Identify the correct risk class (A, B, C, or D).

Step 2: Appointment of Authorized Indian Agent (for foreign manufacturers)
Foreign companies must appoint an Indian representative to handle documentation and coordination with CDSCO.

Step 3: Application on SUGAM Portal
Applications must be filed online via the CDSCO SUGAM portal using forms such as MD-14 or MD-15.

Step 4: Submission of Documents
Key documents include:

  • ISO 13485 Certificate
  • Device Master File (DMF)
  • Plant Master File (PMF)
  • Free Sale Certificate (for imports)
  • Clinical Data (if applicable)

Step 5: Review and Approval
Applications for high-risk devices undergo detailed review and inspections before an import/manufacturing license is issued.

Step 6: Validity and Renewal
Registrations are valid for five years and must be renewed before expiry.

CDSCO Cosmetic Registration Process

Like medical devices, cosmetics also require CDSCO approval before being imported or sold in India. This ensures adherence to safety and labeling standards.

Step 1: Appointment of Indian Authorized Agent
Foreign cosmetic manufacturers must appoint an Indian agent.

Step 2: Filing Application through SUGAM Portal
Applications are submitted via Form COS-1, and approvals are granted in Form COS-2.

Step 3: Submission of Documents
Required documents include:

  • Free Sale Certificate from country of origin
  • Ingredient list of the product
  • Label designs and artworks
  • Manufacturing license from country of origin
  • Specifications and testing reports
  • Power of Attorney for Indian agent

Step 4: Review and Grant of Import License
Once verified, CDSCO issues a cosmetic import license.

Step 5: Validity and Renewal
Cosmetic registrations are valid for three years and must be renewed to avoid business disruption.

Benefits of CDSCO Registrations

  • Regulatory Compliance – Ensures products meet Indian safety standards.
  • Consumer Trust – Builds credibility with customers.
  • Market Access – Legal entry into India’s growing healthcare and cosmetics markets.
  • Smooth Customs Clearance – Prevents rejection or delays at ports.
  • Business Growth – Supports sustainable long-term expansion.

Why Take Professional Assistance?

Both CDSCO medical device registration and the CDSCO cosmetic registration process involve detailed documentation, technical expertise, and coordination with regulators. Professional consultants ensure accurate, timely submissions and help businesses avoid costly mistakes, delays, and penalties.

Contact Us

If you are looking for expert guidance in CDSCO registrations for medical devices and cosmetics, our team is ready to provide end-to-end support.

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

Final Words

Whether you are a medical device manufacturer or a cosmetic importer, compliance with CDSCO is mandatory. The CDSCO medical device registration process and the CDSCO cosmetic registration process ensure consumer safety, smooth customs clearance, and long-term business growth in India’s thriving markets.

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