For Indian MedTech Startups

Each individual, sponsor, clinical researcher, organization, and any other investigator participating in a clinical inquiry or his agent who has permission to do so shall keep the data, record, registers, etc., for seven years from the end of the clinical investigation. The Central Licensing Authority and any other authorized officers may require such information.

Clinical investigation of medical products is the process of obtaining data to evaluate the safety and performance of medical products in their intended use. This medical device performance study includes any side effects or risks the product may cause during its use.

Form MD 22 is an application to get the grant of permission to conduct clinical investigation of medical devices without predicate devices or new ones.

A “clinical investigation plan” is a document that describes the reasons, objectives, design methodology, monitoring, and statistical considerations. It also includes the proposed analysis, monitoring, conduct, and record-keeping for the clinical investigation.

Pilot studies for medical device clinical studies or drug development are typically performed as a priority at the beginning of the process. They can be conducted when little or no clinical experience is available with the device or drug. Pilot studies refer to medical devices or drug clinical trials that gather specific essential information about a device or drug before starting the pivotal trial. These trials will be used to make precise claims about safety and efficacy. A pivotal study for a medical device is a clinical test that attempts to show the efficacy of a new medical device, and it can be used to gain marketing approval from the regulatory authority. A medical device pivotal clinical study aims to demonstrate that a novel experimental medical device is more efficient than an existing standard-of-care medical device.

The Central Licensing Authority can, if satisfied with the application, grant permission to conduct a medical device clinical investigation in Form MD 23.

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

The results of medical device or in-vitro diagnostic kit clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.