CDSCO has published draft guidelines for IVDMD

9 July, 2022

Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has published various draft guidelines for regulation of In-Vitro Diagnostic Medical Device (IVDMD). These guidelines are applicable to all manufacturers/ importers / Testing laboratories/ distributors or use IVD medical devices in India. The various guidelines introduced are as follows:

1. Guidance on Post-Market Surveillance of IVDMD: The purpose of these guidelines is to provide a framework for for conducting post-market surveillance of IVDMD and the procedure to report adverse events of  IVDs falling under Class C and Class D and the Point of Care Test (POCTs) or Home-Use IVD medical devices e.g. Glucometer and strips. The post-market surveillance is to protect individual health and public health through continued surveillance of IVDs once they are placed on the market by reducing any risks. Such activities should ensure the manufacturer ‘s obligations are fulfilled through ensuring they are aware of event which enables them to undertake and assessment of any risks, and as appropriate any suggested steps to risk mitigation. This is to be achieved through evaluation of reported incidents and where appropriate, dissemination of information, which could be used to prevent such repetitions or to alleviate the consequences of such incidents.

This guideline can be assessed here.

2. Overview on Performance Evaluation of IVDMD: IVDs are fundamentally different from other medical devices because they perform their function outside of the body on specimens taken from the human body. Human subjects are typically not exposed to risks with the performance testing of IVD medical devices, except for the risk associated with specimen collection procedures or when they obtained information is used for patient management. The specimens are obtained via normal body functions (e.g. urine) or through the use of invasive medical devices to allow for the specimen to be obtained (e.g. biopsy). The specimens are never reintroduced into the human body. These differences make the performance and risk characteristics of IVD medical devices different and unique from other medical devices.

To understand the Performance evaluation at Independent / External laboratory of IVDs it must be taken into account that IVD medical devices differ from other medical devices, in that the risks and benefits they pose are related to impact on patient management rather than direct contact between the device and the patient. A significant percentage of all healthcare decisions rely on information provided by clinical laboratory tests and these decisions can profoundly influence diagnosis and management of the patient and will be influenced by the risk to the patient of an incorrect result from the IVDs.

Performance evaluations at Independent / External laboratory are performed using samples resulting from the remnants of specimens taken for purposes of standard of care (leftover or archived). In these studies, there is no risk for the subjects arising from either the information provided by the IVD medical device or from the collection procedure of the specimen. This document is not intended for clinical performance evaluation studies as these studies involve specimens taken from the human body not from leftover or archived specimens.

Performance evaluation at Independent / External laboratory of in vitro diagnostics (IVDs) are required, to verify certain performance claims that are  considered essential by which data are assessed and analyzed to demonstrate the performance of IVDs for the intended use as stated by the manufacturer.

This guideline can be assessed here.

3. Guidance on Stability Studies of IVDMD: 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). This document has been developed by the CDSCO to encourage and support convergence of regulatory systems for medical Devices among jurisdictions. CDSCO is looking to adopt the use of this Guidance for premarket license applications and Post approval change applications. CDSCO strongly encourages manufacturers to follow this guidance when Submitting Class C and Class D IVDMD license applications and Post approval change applications.

This guideline can be assessed here.

 

Any person who are interested in making any suggestions on the proposed draft guidance documents may do so in writing for consideration of the CDSCO with in a period of 30 days from the date of its uploading, through post to the Drugs Controller General (India), CDSCO, FDA Bhavan, Kotla Road, New Delhi – 110002 and through email at ivd-division@cdsco.nic.in.