India Releases Guidance on Safety and Performance Principles

July 28, 2017

India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India.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 (IDDM, Feb. 17).

The draft guidance “does not dictate how a manufacturer should prove that their medical devices have met the essential principles,” the Drugs Controller General said, noting the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:

  • 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 confirm to safety principles and take into account state-of-the-art technology. Risk should be controlled to an acceptable level. To minimize risk, the devicemaker should first identify foreseeable hazards and estimate the associated risks. Then it should eliminate as much risk as possible, reduce remaining risk, take adequate protection measures and inform users of any residual risk;
  • Devices need to 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 when the “device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with 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 and it must be classified to demonstrate that it complies with provisions of the essential principles.

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.