Medical Device Clinical Trials In India

Division of cardiovascular devices.

Medical device clinical trials in india. The proposal will ensure further access to state of the art devices in the indian market according to cdsco officials. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. The drug controller general of india dcgi is the key official within the cdsco the dcgi is responsible for the approval of the manufacturing of certain drugs vaccines large volume parenterals blood products r dna derived specific medical devices and new drugs. A detailed guideline for conducting clinical trials in india with the phases of clinical trials are explained.

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and. A permission is also required to undertake clinical trial in india. Fda and the ide process owen faris ph d. Office of device evaluation.

New orders from the indian ministry of health family welfare s central drugs standard control organization cdsco clarify some requirements regarding the country s sometimes opaque medical device registration and clinical trial regulations. However managing a smooth clinical trial process in india s growing markets and evolving regulatory environment can be a challenging task. Cdsco regulates the clinical trials for drugs and medical devices in india. Thus for a product which qualifies as a new drug or investigational medical device the steps needed to be taken to start manufacturing or import of the product in india are.

Per the 2019 ctrules the icmr guidelines and additional resource a it is mandatory for all sponsors applicants to register their clinical trials including academic trials with the indian council of medical research icmr s clinical trials registry india ctri before initiating a. For medical devices the sequence is fairly similar and some devices do go through a clinical trial phase process however most medical devices will go through clinical trial stages instead of phases. Clinical trials for medical devices. First cdsco has reiterated 14 categories of devices that do fall under india s drugs and cosmetics act and qualify for regulation.

Medical device rule 2016 published in part ii section 3 subsection i of the gazette of india important regulatory norms implemented in the field of medical device clinical trials are 1 no person or sponsor shall conduct any clinical investigation in respect of investigational medical device in human participants except in accordance with. India s large population offers many opportunities for medical device pharmaceutical and biotechnology companies looking to conduct clinical trials overseas.