Medical Device Testing to Follow Stricter Standards in India

The Ministry of Health and Family Welfare (MoHFW) is implementing stricter regulations for testing medical devices (MDs) and in-vitro diagnostics (IVDs) in India. This initiative aims to ensure the safety, quality, and performance of these products. This circular was issued on May 29, 2024.

The MoHFW has granted registration to laboratories to conduct Medical Device (MD) / In-Vitro Diagnostic (IVD) testing, strengthening the country’s testing infrastructure.

The Medical Device Rules (MDR) 2017 replaced the Drug Rules 1945 for MDs/ IVDs, mandating adherence to specific product standards.

These standards include:

  1. Bureau of Indian Standards (BIS) standards (if available)
  2. International Organisation for Standardisation (ISO) or International Electro-Technical Commission (IEC) standards
  3. Validated manufacturer’s standards (only if no BIS or ISO/IEC standards exist)

Focus on BIS Standards

The MoHFW has identified an issue where MDs with BIS standards weren’t being tested according to those specific standards. This new directive emphasizes the importance of prioritizing BIS standards for testing whenever they are available.

By focusing on stricter adherence to established standards, the MoHFW aims to improve the quality and reliability of MDs/ IVDs available in India. This will ultimately enhance patient safety and healthcare outcomes.