Can CE or FDA certifications replace BIS certification in India?

No. Even if a medical device has CE or FDA certification, a separate BIS license is mandatory for selling specific medical devices in India.

Which medical devices require mandatory BIS registration?

Many electronic and specialized medical devices require BIS registration under CRS or ISI marking. Over 200 additional devices are expected to be notified soon.

How long does the BIS certification process take for medical devices?

The timeline depends on device type, testing requirements, and factory audits, and can vary from product to product.

What is the validity of BIS certification for medical devices?

BIS certification is generally valid for two years and can be renewed upon expiry.

Who is authorized to issue test reports for BIS certification?

Only BIS-recognized laboratories are authorized to conduct testing and issue valid test reports for BIS certification.

BIS Certification for medical devices in India- (2026) Guide by PSR Compliance

BIS

Fri, Jan 23 2026

Raju Karn

BIS Certification for medical devices in India- (2026) Guide

Name: PSR Compliance
Address: IN
Telephone: +91-7065883416

In 2026, medical device compliance in India is no longer flexible or negotiable. If your medical device falls under mandatory BIS standards and you are selling, manufacturing, or importing it without BIS certification, your business is at direct legal risk. Many manufacturers realise this only after their products are blocked by authorities or removed from hospitals and e-commerce platforms. BIS certification for medical devices is not just a regulatory stamp—it is proof that your product meets Indian safety, quality, and performance standards.

This guide explains which medical devices need BIS certification, how the process works, costs, timelines, and how to stay compliant in 2026.

What Is BIS Certification for Medical Devices?

BIS (Bureau of Indian Standards) certification ensures that medical devices sold in India comply with Indian safety and quality standards.

For medical devices, BIS certification applies mainly under:

In 2026, BIS compliance is increasingly linked with:

CDSCO approvals
Hospital procurement eligibility
Government tenders
Marketplace listings (Amazon, Flipkart, GeM)

If BIS certification is mandatory for your device and you skip it, your product is treated as non-compliant and illegal.

Why BIS Certification Is Critical for Medical Devices in 2026

Medical devices directly affect human life. That’s why BIS enforcement has become stricter every year.

Without BIS Certification, You May Face:

➜ Product seizure by authorities

➜ Sales ban across India

➜ Import clearance rejection

➜ Heavy penalties

➜ Loss of hospital & distributor trust

In 2026, many states are also coordinating BIS checks with drug inspectors and CDSCO officials, increasing compliance pressure.

Which Medical Devices Require BIS Certification?

BIS certification is product-specific, not company-specific.

Common Medical Devices Under BIS Standards:

➤ Patient monitoring devices

➤ ECG machines

➤ X-ray and imaging equipment

➤ Infusion pumps

➤ Blood pressure monitors

➤ Medical electrical equipment

➤ Diagnostic devices

Each product is mapped to a specific Indian Standard (IS code). If your device falls under a notified IS standard, BIS certification becomes mandatory.

BIS Certification vs CDSCO Approval

Many businesses confuse BIS with CDSCO. In reality, both may be required.

Aspect	BIS Certification	CDSCO Approval
Focus	Product quality & safety	Regulatory & clinical control
Authority	Bureau of Indian Standards	CDSCO
Applies To	Specific products	Medical devices & drugs
Mandatory	If IS standard exists	Based on device class

👉 In many cases, CDSCO approval + BIS certification together are required for legal sale.

BIS Certification Process for Medical Devices (Step-by-Step – 2026)

Step 1: Identify Applicable BIS Standard

Match product with relevant IS code
Confirm if certification is mandatory

Step 2: Factory & Product Evaluation

Manufacturing process review
Quality control system assessment

Step 3: Product Testing in BIS-Approved Lab

Safety tests
Performance validation
Electrical & mechanical testing

Step 4: BIS Application Submission

Online application filing
Document upload
Fee payment

Step 5: Factory Inspection (If Applicable)

BIS officer inspection
Compliance verification

Step 6: Grant of BIS License

Certification issued
Product allowed to carry BIS mark

Documents Required for BIS Certification (Medical Devices)

Here’s where many applications fail due to incomplete paperwork.

Key Documents:

→ Product technical details

→ Test reports from BIS-recognised lab

→ Manufacturing process flow

→ Quality manual

→ Factory layout & machinery list

→ Authorized signatory documents

Missing or inconsistent documents can delay approval by weeks or months.

BIS Certification Cost for Medical Devices

BIS cost depends on:

‣ Product category

‣ Number of models

‣ Testing requirements

‣ Factory location

Typical Cost Includes:

• Government fees

• Testing charges

• Inspection fees

• Professional consultancy (if used)

💡 Investing correctly upfront avoids costly rejections later.

Need support with BIS certification for medical devices?
PSR Compliance helps you understand BIS rules, prepare documents, and complete the certification process smoothly.
📞 Call +91-7065883416

FAQs on BIS Certification for medical devices

1. Can CE/FDA certifications replace BIS?

No. Even with international certifications like CE or FDA, a separate BIS license is mandatory to sell specific medical devices in India.

2. Which devices require mandatory BIS registration?

Currently, many electronic and specialized medical devices require BIS registration under the Compulsory Registration Scheme (CRS) or ISI marking. A list of over 200 additional devices is expected to be finalized soon.

3. What is the penalty for non-compliance?

Selling medical devices without a valid BIS license can lead to prosecution and seizure of products under the BIS Act and Electronics and IT Goods Order.