Understanding BIS Recognition for Medical Device Testing Labs

Bureau of Indian Standards (BIS) recognition for medical device testing laboratories has become a cornerstone of India’s healthcare compliance framework. With the government expanding its regulatory oversight through the Medical Devices Rules (MDR) 2017 and fast-tracking standards for 214 critical devices by December 2025, BIS recognition ensures that testing labs provide reliable, accredited, and regulatory-accepted results.

For manufacturers, working with a BIS-recognized and NABL-accredited testing partner like Astute Labs means seamless access to the Indian market and global credibility.

Defining BIS Recognition for Medical Device Testing

BIS recognition is the formal acknowledgment that a laboratory meets the technical, infrastructural, and operational criteria required to test medical devices under Indian standards.

It operates under the Laboratory Recognition Scheme (LRS), mandated by Section 13(4) of the BIS Act, 2016 and Rule 32 of the BIS Rules, 2018. Recognized labs are authorized to conduct tests that support certification under schemes like the Compulsory Registration Scheme (CRS) and ISI Marking.

Astute Labs, with accreditations from BIS, NABL, CDSCO, and QAI, is positioned as a trusted testing partner that aligns directly with BIS recognition criteria.

Device Standards for BIS Recognition (2025)

Replace the previous list of standards with this table for clarity on device-specific standards labs must be equipped to test against in 2025:

With accelerated standards development for 214 critical devices, including defibrillators, ventilators, anesthesia machines, and phototherapy equipment, labs must scale their infrastructure and competencies rapidly.

Astute Labs supports manufacturers in this transition with advanced capabilities for medical device testing and expertise in standards like IEC/EN 60601.

How the BIS Laboratory Recognition Scheme Works

The BIS LRS was created to expand testing capacity beyond BIS’s own eight laboratories. Its objectives include:

• Expanding geographic access to testing facilities in India and abroad
• Maintaining strict quality and technical benchmarks
• Supporting conformity assessment programs under BIS schemes

Eligibility for recognition requires:

• Accreditation to IS/ISO/IEC 17025 in relevant fields
• Accreditation by ILAC or APAC signatories
• Demonstrated technical staff competence
• Robust testing infrastructure with calibrated equipment

Astute Labs exceeds these requirements through state-of-the-art facilities in Pune, advanced EMI/EMC setups, and an expert team with over 15 years of regulatory testing experience.

The BIS Recognition Application Pathway

Recognition involves a multi-phase process:

Phase 1: Submission

• Compile documents: accreditation certificate, equipment list, test scope, process flowcharts
• Submit application via BIS portal with prescribed documentation

Phase 2: Evaluation

• Documentation review by BIS
• On-site inspection and verification of lab infrastructure
• Competency validation through test sample evaluation

Phase 3: Grant of Recognition

• Issuance of recognition certificate
• Scope of recognition clearly defined for specific medical device categories

Surveillance audits and renewal every three years maintain recognition.

Post-Recognition Compliance: What Labs Must Maintain

Recognition is only the first step. Laboratories must:

• Continue operating under ISO/IEC 17025 frameworks
• Maintain calibrated equipment under strict protocols
• Undergo surveillance audits to demonstrate ongoing competency
• Document testing procedures and quality checks consistently
• Participate in inter-lab comparisons and proficiency testing

Integration of BIS Recognition with CDSCO Requirements

BIS recognition is not standalone; it integrates closely with CDSCO’s framework under MDR 2017:

• Medical device testing labs must register with CDSCO using Form MD-39 to obtain MD-40 authorization
• CDSCO requires BIS standards compliance for quality and safety testing
• Where BIS standards are unavailable, ISO and IEC standards are accepted

Astute Labs bridges this integration by offering BIS-aligned testing that supports CDSCO approvals. For deeper insights, explore our blog on CDSCO approval processes.

Why BIS Recognition Matters for Manufacturers

For domestic manufacturers:

• Ensures testing at BIS-recognized labs before product launch
• Establishes compliance with IS 23485 and device-specific IS standards

For international manufacturers:

• Requires testing in BIS-recognized labs via an Authorized Indian Representative
• Provides smoother market entry and acceptance of test results

Astute Labs enables both domestic and international companies to meet BIS and CDSCO requirements, offering end-to-end support from testing to dossier preparation.

Market Benefits of BIS-Recognized Testing Labs

• Direct acceptance of test reports by BIS for certification
• Faster product approvals under CRS and ISI schemes
• Increased credibility with regulators and manufacturers
• Access to new market opportunities as BIS standards expand
• Recognition under international mutual recognition agreements through NABL and ILAC

By partnering with Astute Labs, manufacturers gain access to recognized testing expertise that accelerates compliance and builds trust with regulators.

Preparing for 2025: Industry Developments

By 2025–2026, BIS and CDSCO are implementing significant reforms:

• 214 device standards fast-tracked for certification by December 2025
• Six-month transition periods for new standards
• Increased focus on AI-powered and connected devices with advanced EMC testing needs
• Migration of applications to digital platforms like the SUGAM portal for efficiency
  

Astute Labs is proactively upgrading capabilities to address these changes, investing in equipment and expertise for next-generation devices including ventilators, infusion pumps, and diagnostic systems. For more, see our blogs on ventilator testing and infusion and syringe pump validation.

Building Trust Through BIS-Aligned Testing at Astute Labs

BIS recognition sets the foundation for credibility in medical device testing. With accreditations from BIS, NABL, CDSCO, and QAI, Astute Labs not only meets regulatory requirements but also provides manufacturers with confidence that their products will be market-ready.

Our offerings span:

• Medical Device Testing
• EMI/EMC Diagnostics
• IT/Audio-Video Product Evaluations

By choosing Astute Labs, manufacturers align with a partner whose credentials and expertise are fully recognized under BIS frameworks. If you are planning for BIS recognition, certification, or market entry in 2025, contact us today and let us help build your compliance roadmap.