The Central Drugs Standard Control Organization (CDSCO) is an agency of the Government of India under the Ministry of Health & Family Welfare. We assist you in obtaining the license for the marketing & manufacturing of drugs in India. We are updated with drug rules and thus ensure your compliance with regulatory requirements. We provide you with a complete service for doing business in India. We at CDSCO help you get your drug license in the easiest, fastest, and most hassle-free manner. We assist the clients in getting a CDSCO license for manufacturing, importing, exporting, and marketing drugs & cosmetics across India. We ensure that all the required documentation is provided to obtain the desired licenses and certificates. If you are looking for CDSCO license registration in India, your search ends here. We are India’s leading CDSCO license consultant and assist companies in obtaining a manufacturing license (Form 28-28A) or a marketing authorization (Form 29LA) under the Drugs and Cosmetic Act, 1940. CDSCO is the national drug standard regulatory body that ensures drug safety. A valid CDSCO license is necessary for manufacturing, marketing, or importing any drug in India. A license under CDSCO is mandatory for any company to start its operations in India. The license ensures the product’s compliance with industry standards and ensures a safe product enters the Indian market. CDSCO License in India is mandatory to import cosmetics and drugs in India. Apply for CDSCO import permission and medical device registration with our experts and expert legal consultants. Our CDSCO License Experts will give the best solutions to your Global business standards. The CDSCO act is an act that deals with the control of the import, manufacture, distribution, and sale of drugs in India. To import Drugs, Medicines, or Cosmetics into India, one needs to complete Drug Registration & Import Procedure successfully, as mentioned by CDSCO website guidance.
We are India’s leading CDSCO Consultant & Guide for all guidelines, laws & regulations regarding the import of drugs, medicine, and cosmetic products by the Central Drugs Standard Control Organization (CDSCO). We are India’s leading CDSCO Consultant & Guide for all guidelines, laws & regulations regarding the import of drugs, medicine, and cosmetic products by the Central Drugs Standard Control Organization (CDSCO). Our quality services include online applications for registration, certificate of Pharmaceutical Products (CoPP), test report scheme for importing goods in India. We provide all possible assistance to Indian Importers from Canada, the United States of America, Europe, China, and other countries to facilitate importing goods in Indian territory. We will give a step-by-step procedure of applying for Registration & Import Permission and filling different forms required for CDSCO Certification and Medicines/Cosmetics. We help registered importers worldwide, especially US businesses seeking new opportunities in India, with online CDSCO Certification of Medicines, Drugs & Cosmetics.
Relaxation to obtain CDSCO Certificate:
- The government has given time to the medical device industry to transition into the regulatory framework and to obtain ISO 13485 certification, if not already obtained.
- The government has relaxed the requirement to obtain registration and license for Newly Notified Medical Devices for the following period.
The following, Import for CDSCO Rules:
- Registration will be required to import or manufacture such medical devices, but no license will be required.
- License will be required to manufacture, import, distribute or sell Class A or Class B medical devices, but no license will be required to manufacture, import, distribute or sell Class C or Class D medical devices.
- License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.
Drugs Import & Registration:
- The import of Drugs into India is regulated under Chapter III of Drugs & Cosmetics Act & Part IV of Drugs & Cosmetics Rules.
- The applications for registration certificate & import license of drugs are processed as per the Drugs & Cosmetics Rules.
Documents Required for CDSCO License:
- Form 40
- ISO 13485 certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all information provided is authentic
- Either a Free Sale Certificate or Certificate from the Foreign Government
- Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
- Plant Master Report
- Device Master File.
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