India Releases Final Guidance on Safety and Performance Principles

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.

IVD Reagents

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:

• Devices are to be designed and manufactured so that they perform as intended and don’t compromise the clinical condition or safety of patients;
• Solutions adopted by the devicemaker should conform to safety principles and take into account the state of the art. To minimize risk, the manufacturer should first identify foreseeable hazards and estimate the associated risks. Then it should eliminate as much risk as possible, reduce remaining risk, and inform users of any residual risk;
• Devices should achieve their intended performance and be designed, manufactured and packaged so that under normal conditions they are suitable for their intended purpose;
• The characteristics and performance of the device should not adversely affect the health or safety of the patient or user under normal conditions of use according to the manufacturer’s instructions;
• Devices should be designed, manufactured and packaged so that their characteristics and performance are not adversely affected by transport and storage conditions;
• All known and foreseeable risks “and any undesirable effects” should be minimized and be acceptable when weighed against the benefits of the device under normal conditions; and
• Every device requires clinical evidence appropriate for its intended use.

Read the final guidance here: www.fdanews.com/05-10-18-Indiaprinciples.pdf.