Drug- Authorized Agent

Drug- Authorized Agent/ Registration Holder Support

The Central Drugs Standard Control Organization (CDSCO) oversees medical devices in India. It is governed by the Drugs and Cosmetics Act and Rules, which regulate the manufacturing, importation, sale, and distribution of medical devices. Dental implants, cochlear implants, spinal needles, tracheostomy tubes, annuloplasty rings, syringes and needles, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, catheters, and other medical equipment all need to be registered in India.

Companies willing to register, market, import, or sell a medical device legally in India must follow CDSCO requirements. In other cases, such as when a company does not have a local presence or a registered office in India, an authorized agent acts as a liaison between the overseas manufacturer and the government, handling registrations and post-market surveillance procedures.

A hired “Authorized Representative” will be accountable for the manufacturer’s business activities in India, including all aspects of compliance with the regulatory authority’s Act. Only one India “Authorized Agent” will be responsible for post-market surveillance and pre-certification for the entire country.

Oraculum will legally represent you in India without any financial conflicts of interest, such as product promotion, distribution, or sales.