Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro diagnostics producers in India will soon be able to evaluate performance, conduct postmarket surveillance, and conduct stability studies based on these three draft guidance documents.
In Vitro Diagnostic Medical Devices are used to conduct tests outside of the human body to provide valuable information regarding a person‘s health or physiological status. They include tests and related devices, such as test strips and reagents, using specimens such as blood, tissue or urine etc., to carry out screening, diagnosis, prognosis, predictive testing, and monitoring of conditions.
The 3 Guidances are
Performance Evaluation: The purpose of this guidance is to facilitate the manufacturers/ importers / Testing laboratories of IVDs in our country; this document may also serve to sensitize the interested stakeholders to the concepts of performance Evaluation / External evaluation.
Post-Market Surveillance: The purpose of this guidance is to facilitate and strengthen the reporting of Adverse Events attributable to in-vitro diagnostic medical devices in India and to facilitate access to safe, appropriate and affordable in vitro diagnostics (IVDs) of good quality in an equitable manner.
Stability Studies: This document is intended to aid manufacturers in the preparation of scientific information to be provided in support of claimed shelf life, in use stability and shipping studies for Class C and Class D IVDMD license applications and Post approval change application filed in pursuant to the Medical Devices Rules, 2017 (MDR-2017).