CDSCO CERTIFICATION

CDSCO Certification is a mandatory regulatory certification granted by the Central Drugs Standard Control Organization (CDSCO) under the ministry of health and family welfare, government of India. It provides that the production, importation, or sale of drugs, medical devices, cosmetics, and devices, and other products notified as medical products is done in connection with the Indian safety, quality, and technical standards.

Products cannot be legally introduced into the Indian market without the CDSCO approval. The compliance will prevent rejection of shipments, fines and delays in the customs but make approvals and market entry fast and with expert regulatory assistance.

An official regulatory approval by the Central Drugs Standard Control Organization that a product meets the requirements of Indian law, safety standards and quality standards can be referred to as a CDSCO Certificate.

Any company that is planning to manufacture, import, distribute or sell regulated products like pharmaceuticals, medical devices, cosmetics or regulated health products in India must seek the approval of CDSCO before commercialization.

CDSCO certification is a guarantee that:

The Indian regulatory bodies have made CDSCO certification essential to protect the health of the people and retain only safe, effective and compliant products to the consumers.

Manufacturing, importing, selling, and distribution of the products cannot be done in India without the prior permission of CDSCO. Failure to comply can result in shipment detention, product recall, license revocation, fines or prosecution.

Further, CDSCO certification helps to align products to internationally accepted regulatory practices, which enhances confidence among regulatory bodies, healthcare providers, distributors, and consumers.

Registration of CDSCO is compulsory on:

Certainly, whether a business is in the healthcare industry or not, CDSCO certification is a legal consideration to conduct business in the regulated healthcare sector in India.

To ensure a smooth application process, the following documentation must be prepared and submitted:

To obtain CDSCO approval, businesses must adhere to strict quality and legal standards:

Gaining entry to the Indian market involves meeting specific regulatory milestones:

A highly skilled CDSCO consultant guarantees proper product categorisation, proper documentations and expedited approvals. Professional advice will lessen mistakes during the application, decrease the likelihood of rejection and guarantee compliance with regulations in the long run.

EVTL India offer end-to-end CDSCO certification/regulatory compliance services to international and domestic companies:

Our experience means that the approvals are done in time, the rejections are zero and the regulatory laws of India are met to the letter.

All businesses intending to manufacture, import or sell regulated products in India must have CDSCO Certification. It can assure adherence to Indian policies, reduce legal risks and create long-term market credibility.

The CDSCO consultants who handle the documentation, registration and approvals are experienced and hence the certification process is hassle free, accurate and without stress and hence market entry is smooth and long-term regulatory compliance is maintained.