Medical Device / Ivd Test License (CDSCO)

A CDSCO Medical Device/IVD Test License is a regulatory authorization granted by the Central Drugs Standard Control Organization (CDSCO) in India. This licence permits manufacturers and importers to import, manufacture, and distribute medical devices and in vitro diagnostics (IVDs) specifically for the purposes of testing, examination, and evaluation.

The primary purpose of the Medical Device/IVD Test License is to enable manufacturers and importers to conduct necessary tests and evaluations on their products. This includes clinical trials, performance evaluations, and validation studies, which are crucial for demonstrating that a medical device or IVD is safe and effective for its intended use. The test licence is particularly important for new and innovative products that require thorough testing to meet regulatory requirements.

Application Process

The process of obtaining a Medical Device / IVD Test License involves:

Application Submission: The applicant must submit an application in Form MD-12 to the CDSCO. This form includes detailed information about the medical device or IVD, the purpose of the testing, and the testing protocols. Along with Form MD-12, the applicant must provide supporting documents such as the Free Sale Certificate (FSC) from the country of origin (if applicable), technical specifications, and quality assurance procedures.

Authorised Indian Agent: For foreign manufacturers, it is mandatory to appoint an authorised Indian agent who will be responsible for regulatory compliance and communication with the CDSCO. The agent must hold a valid wholesale licence and act as the point of contact for all regulatory matters related to the test licence.

Review and Evaluation: The CDSCO conducts a thorough review of the application and supporting documents. This review includes an assessment of the proposed testing protocols, the qualifications of the personnel involved, and the adequacy of the facilities where the testing will be conducted. The goal is to ensure that the testing will be conducted in a scientifically sound and ethical manner.

Inspection: In some cases, the CDSCO may conduct an inspection of the testing facilities to verify compliance with Good Laboratory Practices (GLP) and other regulatory requirements. This inspection ensures that the facilities are equipped to conduct the necessary tests and that the personnel are competent and trained.

Granting of Licence: If the application and inspection (if conducted) are satisfactory, the CDSCO grants the test licence in Form MD-13. This licence authorises the importation, manufacture, and distribution of the medical device or IVD for the specified testing purposes.

Documents Required For Test Licence: