Following consultation with stakeholders, India’s Drugs Controller General adopted essential principles for safety and performance of medical devices marketed in India.
The final guidance sits alongside India’s new Medical Device Rules, which went into effect on Jan. 1.
The final guidance closely mirrors a draft issued in July 2017 but it provides more detail and breaks down categories of devices and in vitro diagnostics more specifically.
In one change from the draft document, the final guidance omits a portion of the preface that said it “does not dictate how a manufacturer should prove that their medical devices have met the essential principles.”
The final guidance differentiates between three different types of standards: basic or horizontal standards; group or semi-horizontal standards; and product or vertical standards.
Basic standards indicate fundamental concepts, principles and general safety requirements that apply to a wide range of products and processes. This includes risk management, clinical trials and the quality management system.
Group standards are those that apply to families of similar products such as standards for sterile devices or those for in vitro diagnostic reagents. Product standards are the necessary safety and performance standards for specific types of devices such as infusion pumps or blood glucose monitors.
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 precision and stability based on appropriate scientific design to address sensitivity, specificity, and reproducibility. The guidance stresses traceability and quality control measures.
The guidance covers risks associated with medical devices incorporating biologic materials, including tissues and derivatives of microbial recombinant origin. It also covers infection and microbial contamination, manufacturing and environment properties, combination devices and devices that incorporate software.
The guidance lays out the following essential principles for all categories of medical devices:
Read the final guidance here: www.fdanews.com/05-10-18-Indiaprinciples.pdf.