About the Author: kumaraxshit

Akshay - CDSCO Consultant for Cosmetic Products and Medical Devices Akshay is a highly skilled CDSCO consultant specializing in cosmetic product registration and medical devices in India. With a deep understanding of the Central Drugs Standard Control Organisation (CDSCO) regulations, Akshay provides expert guidance to ensure compliance and successful registration of cosmetic products and medical devices. Professional Background: Role: CDSCO Consultant Specialization: Cosmetic Product Registration, Medical Devices Location: India Website: regacats.in Services Offered: CDSCO Compliance: Akshay handles all CDSCO-related compliances, ensuring that cosmetic products and medical devices meet the necessary regulatory standards. Cosmetic Registration: Assists clients with the registration of cosmetic products in India, navigating the complex regulatory landscape to achieve successful registration. Medical Device Registration: Provides comprehensive support for the registration of medical devices, including import registration and compliance with CDSCO guidelines.

What Documents are Required for Cosmetic Registration?

Table of Contents

To register cosmetics in India, the following documents are typically required:

Manufacturing-Related Documents:

Manufacturing License: A copy of the manufacturing license issued by the State Licensing Authority.

Good Manufacturing Practice (GMP) Certificate: A certificate demonstrating compliance with GMP guidelines.

Product-Related Documents:

Product Formula: A detailed formula of the product, including all ingredients and their concentrations.

Product Specifications: Specifications of the product, including its physical and chemical characteristics.

Stability Study Report: A report demonstrating the stability of the product under various conditions.

Safety Data Sheet (SDS): An SDS for each ingredient used in the product.

Labeling and Packaging Documents:

Labeling Information: A copy of the labeling information, including the product name, ingredients, instructions for use, and any warnings or cautions.

Packaging Information: Details of the packaging material, including its composition and specifications.

Regulatory-Related Documents:

COS-1 Form: A completed COS-1 form, which is the application form for cosmetic registration. (check here)

Undertaking and Declaration: An undertaking and declaration by the manufacturer or importer, stating that the product complies with Indian regulations.

Other Documents:

Certificate of Analysis: A certificate of analysis for each batch of the product.

Free Sale Certificate: A free sale certificate from the country of origin, demonstrating that the product is approved for sale in that country.

Please note that the specific documents required may vary depending on the type of product and the regulatory requirements applicable to it.

kumaraxshit2025-01-15T20:32:48+05:30