India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India.
The country recently finalized new medical device regulations and the regulators worked with device and diagnostics stakeholders to develop principles for compliance with the new rules.
Effective Jan. 1, 2018, device manufacturers will no longer be required to comply with regulations written for pharmaceuticals. For example, the drug regulations mandate four-phase clinical trials, whereas the new device regulations require two-phase trials ().
The draft guidance “does not dictate how a manufacturer should prove that their medical devices have met the essential principles,” the Drugs Controller General said, noting the document provides flexibility so manufacturers can continually use the most advanced technologies to develop new devices.
The guidance lays out the following requirements of safety and performance that apply to all medical devices and IVDs:
Clinical evaluation should include clinical investigation reports, literature reviews or clinical experience to establish a favorable benefit-risk ratio – and clinical studies must be carried out according to the new Medical Device Rules.
For diagnostic devices with a measuring function, the emphasis is placed on accuracy, precision and stability based on appropriate scientific design to address sensitivity, specificity, and reproducibility. The guidance stresses traceability and quality control measures.
The 27-page guidance also covers risks associated with medical devices incorporating biologic materials, including those incorporating cells, tissues and derivatives of microbial recombinant origin. It covers infection and microbial contamination, manufacturing and environment properties, combination devices, devices that incorporate software, protection against mechanical risks and radiation, performance evaluation and labeling requirements.
Definitions for analytical performance, clinical data and evaluation; harm, risk and hazards; are also included.
Read the draft guidance document here: www.fdanews.com/07-27-17-EssentialPrinciplesSafety.pdf.