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BIS Marking for Medical Devices: A Step Towards Quality Assurance in Healthcare

Published on: April 21, 2025

The Indian medical device industry has been growing rapidly, driven by technological advancements, increased healthcare awareness, and government initiatives to improve public health infrastructure. With this growth, ensuring the safety and quality of medical devices becomes crucial—not just for regulatory compliance, but to protect human lives.

That’s where BIS marking comes in.

The Bureau of Indian Standards (BIS), India’s national standards body, plays a vital role in regulating and standardizing products across sectors. For medical devices, BIS certification ensures that the equipment or product meets specific quality, safety, and performance standards.

In this blog, we’ll explore what BIS marking means for medical devices, why it’s important, how to obtain it, and how it aligns with India's vision of becoming a global medical device manufacturing hub.

What is BIS Marking?

BIS marking is a quality certification granted by the Bureau of Indian Standards. It certifies that a product conforms to the standards set by BIS for safety, reliability, and performance. The BIS standard mark, commonly known as the ISI mark, is a symbol of quality assurance.

For medical devices, BIS certification ensures that the device is manufactured as per the Indian Standard applicable to its category. As of recent regulatory updates, certain medical devices have been brought under compulsory BIS certification to enhance product quality and patient safety.

Why is BIS Certification Important for Medical Devices?

→ Patient Safety: Devices are tested for biocompatibility, electrical safety, and mechanical stability.
→ Quality Assurance: BIS standards enforce strict production and testing protocols.
→ Regulatory Compliance: Manufacturers must comply with Indian laws for market access.
→ Consumer Confidence: Hospitals and healthcare institutions prefer BIS-certified equipment.
→ Global Acceptance: Indian standards are increasingly being harmonized with international norms (like ISO and IEC), making BIS-certified devices export-ready.

Medical Devices Under Compulsory BIS Certification

The Indian government, under the Ministry of Health and Family Welfare, has started phasing in mandatory BIS certification for specific categories of medical devices. This is part of an effort to regulate what was once a loosely monitored sector.

→ Surgical gloves (IS 13422)
→ Syringes (IS 10258)
→ Needles (IS 10654)
→ Thermometers (IS 3055)
→ Blood Pressure Monitors
→ Orthopedic Implants
→ Condoms (IS 13437)
→ Examination Gloves (IS 15354)

More categories are being added gradually in consultation with stakeholders, including the Central Drugs Standard Control Organisation (CDSCO).

BIS Certification vs CDSCO Registration

→ CDSCO (Central Drugs Standard Control Organisation): India’s medical device regulator. It mandates registration for all medical devices and ensures clinical safety and efficacy.
→ BIS: Ensures product quality and conformity to Indian standards through testing, audits, and marking.

Many devices now require both BIS certification and CDSCO registration for legal sale in India.

BIS Certification Process for Medical Devices

Identify the Applicable Indian Standard (IS): Determine whether your product falls under any mandatory standard listed by BIS. This will define the testing and compliance requirements.
Submit Application: Apply online via the BIS portal by selecting the relevant certification scheme:
- → ISI Mark Scheme for domestic manufacturers
- → FMCS (Foreign Manufacturers Certification Scheme) for overseas manufacturers
Document Submission: Submit essential documents, including:
- → Company registration
- → Manufacturing license
- → Quality manuals
- → Product specifications
- → Test reports (if available)
Factory Inspection: BIS officials visit the manufacturing facility to verify:
- → Infrastructure
- → Testing labs
- → Quality control processes
- → Storage and packaging methods
Sample Collection and Testing: Product samples are taken during inspection and tested in BIS-recognized laboratories to verify compliance with applicable standards.
Grant of BIS License: If the product passes inspection and testing, BIS grants a license to use the ISI mark on the product and packaging.
Ongoing Surveillance: Even after certification, BIS conducts regular surveillance audits and testing to ensure continued compliance.

Challenges in BIS Certification for Medical Devices

→ Understanding Indian Standards: Lack of clarity on applicable IS codes.
→ Technical Documentation: Detailed paperwork and technical documentation are mandatory.
→ In-house Lab Requirements: Some manufacturers may lack the necessary lab equipment.
→ Delay in Testing: Testing labs may take time to issue conclusive reports.
→ Cost Implications: Expenses related to inspection, testing, and compliance upgrades.

How to Ensure a Smooth BIS Certification Process

→ Conduct a gap analysis to check current compliance levels.
→ Set up a BIS-compliant testing lab within the facility.
→ Ensure their quality control system aligns with BIS norms.
→ Prepare all documentation in advance.
→ Seek help from compliance consultants familiar with BIS processes.

Benefits of BIS Certification for Medical Device Manufacturers

→ Market Legitimacy: Only certified products can be sold legally.
→ Better Market Access: Hospitals, clinics, and government tenders prefer BIS-certified products.
→ Reduced Product Liability: Certified products are less prone to safety-related litigations.
→ Global Competitiveness: BIS standards are often harmonized with international quality benchmarks.
→ Brand Value: The ISI mark adds credibility and trust to your brand.

Future of BIS in Medical Device Regulation

The BIS framework is evolving rapidly to keep pace with technological innovations in the medical field. As India moves toward being self-reliant under the “Make in India” and “Atmanirbhar Bharat” missions, BIS is expected to play a pivotal role in defining and enforcing global-quality standards domestically.

Expect newer categories like wearable medical devices, diagnostic imaging systems, and digital health tools to be brought under BIS purview in the near future.

Conclusion

BIS marking is a critical component in India’s regulatory landscape for medical devices. It ensures that devices

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