Regulatory Services

BIS Registration-Medical Devices

Expert Consultancy for BIS Registration of Medical Devices

Ensuring compliance with the Bureau of Indian Standards (BIS) is crucial for medical device manufacturers and importers in India. Our BIS Registration Consultancy provides complete assistance in obtaining BIS certification for medical devices, enabling you to meet regulatory requirements and expand your market presence in India.

Why BIS Registration for Medical Devices?

The BIS certification ensures that medical devices meet the necessary safety, quality, and performance standards as prescribed by the Indian regulatory framework. Under the Compulsory Registration Scheme (CRS) and Indian Standards (IS), BIS registration is mandatory for certain categories of medical devices to ensure patient safety and product reliability.

Our BIS Registration Consultancy Services

Regulatory Guidance

Expert consultation on BIS compliance as per applicable Indian Standards.

Documentation Support

Assistance in preparing and verifying required documents.

Testing & Certification

Coordination with BIS-approved laboratories for product testing.

Application Filing

Submission of BIS registration application and follow-ups with authorities.

Compliance Management

Ensuring adherence to BIS norms for hassle-free approvals.

Post-Registration Support

Assistance with renewals, modifications, and surveillance audits.

Steps for BIS Registration of Medical Devices

Product Categorization

  • Identifying applicable BIS standards for your medical device.

Testing & Documentation

  • Conducting lab tests in BIS-approved facilities and preparing technical documents.

Application Submission

  • Filing the online registration with BIS along with the required documents.

Audit & Approval

  • Liaison with BIS officials for factory inspection and final certification.

Grant of BIS Certification

  • Upon successful evaluation, BIS certification is issued for the medical device.

Medical Devices Covered Under BIS Registration

Certain medical devices fall under BIS certification as per Indian Standards. These include:

  • Digital Thermometers
  • Blood Pressure Monitors
  • Glucometers
  • Ultrasound Equipment
  • Surgical Instruments
  • Patient Monitoring Systems

Required Documents for BIS Registration

  • Manufacturer’s Business License
  • ISO 13485 Certification (Quality Management System for Medical Devices)
  • Technical Specification Sheets
  • Test Reports from BIS-Approved Labs
  • Factory Inspection Report (if applicable)
  • Authorized Indian Representative (for foreign manufacturers)

Benefits of BIS Certification

  • Legal Compliance & Market Access in India
  • Improved Product Credibility & Consumer Trust
  • Higher Quality & Safety Standards
  • Competitive Advantage in the Medical Device Industry
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

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