CDSCO Registration Certificate
A valid CDSCO registered license helps every medical importer, and manufacturer to operate some of these trade activities easily-
1. Selling imported or domestically manufactured drugs, cosmetics, and medical devices
2. Gain buyer’s trust with assured product safety and quality
3. Simplifying medical import-export operations
4. Conduct CDSCO-approved clinical tests and trials before transferring those to distributors
CDSCO Registration – Overview
A valid CDSCO Registration helps every importer-exporter, manufacturer to comply with CDSCO regulations. The word CDSCO stands for Central Drugs Standard Control Organization under India’s Ministry of Health and Family Welfare.
It works closely with State Drug Control Organization to oversee drug approval, clinical trials, quality control and import-export regulations. The CDSCO operates under Drugs and Cosmetics Act, 1940 and Drug and Cosmetics Rule, 1945.
The CDSCO Registration is required for following businesses –
1. Importer-Exporter of pharmaceuticals, medical devices, cosmetics, and diagnostic equipment
2. Domestic manufacturer of drugs, cosmetics, and medical devices
3. Authorized Indian agents representing foreign manufacturers
4. Foreign medical companies with Indian subsidiary
Key Regulatory Functions of CDSCO
The key regulatory functions of CDSCO include the following activities –
● Assure financial assistance to export scheduled Products
● Conduct surveys from time to time to identify major issues and loopholes affecting the cross-border export of Scheduled Products
● Offer subsidy schemes to protect the trade interest of domestic exporters.
● Carry out inspections on meat and processed meat products, processing plants, slaughterhouses for assuring safety and quality of the products.
● Aligns with MPEDA and other HCCAP regulations for securing export facilitation of seafood and fishes.
● Assures export-oriented packaging, and marketing of the products for benchmarking those as per international Trade Standards.
Reach us to obtain online CDSCO registration now for securing the Export of Scheduled Products.
Key Benefits of Obtaining CDSCO Registration Certificate for Scheduled Export
Business with CDSCO license always have an extra edge in trade facilitation of medical devices. Apart from availing this advantage, CDSCO Registration also unleashes few other trade benefits like-
1. Legal permit to sell imported and domestically manufactured medical equipment
2. Fair and transparent business operations, assuring product safety
3. Avoiding unwanted delay in customs clearance
4. Faster approval of CDSCO application via official CDSCO Registration portal
5. Cost-effective process that involves minimalistic paperwork
6. Smooth facilitation of medical device import and distribution
Documents Required for CDSCO Registration
1. Valid ID Proof of the applicant
2. Address Proof of the applicant
3. Undertaking form from government authority
4. Form MD-1 for CDSCO registration
5. Cover letter from the applicant’s end
6. Description of the medical product
7. Copy of BA/BE site registration approved by CDSCO in case of BA/BE approved site registration
8. Manufacturing license or wholesale license in case of import or manufacturer of Drugs/Blood Product Registration/Test License Registration
