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

BIS certification for medical devices in India is an important compliance requirement for products covered under applicable BIS standards and Quality Control Orders (QCOs). If a medical device requires BIS certification and is manufactured, imported, or sold without the required certification, the business may face regulatory action. BIS certification is not just a regulatory formality-it demonstrates that the product meets applicable Indian safety, quality, and performance standards.

This guide explains which medical devices need BIS certification, how the certific

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:

• Compulsory Registration Scheme (CRS)
• Product-specific Indian Standards (IS)

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 vs CDSCO Approval 

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

👉 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.

Get Expert Help with BIS Certification for Medical Devices

Need BIS Certification or regulatory compliance support for medical devices in India? PSR Compliance can help you identify the applicable requirements, prepare technical documents, coordinate testing, and support the certification and licensing process.

📞 Call: +91 8796104190
📧 Email: support@psrcompliance.com

Frequently Asked Questions (FAQs)

Is BIS Certification mandatory for medical devices in India?

It depends on the specific medical device and the applicable Indian Standard or regulatory requirement. Medical devices are primarily regulated under the Medical Devices Rules, 2017, administered by CDSCO. 

What is the difference between BIS Certification and CDSCO Registration?

BIS Certification relates to compliance with applicable Indian Standards and BIS conformity requirements, while CDSCO regulates medical devices through the Medical Devices Rules, 2017, including applicable manufacturing and import licensing requirements. 

Which medical devices are regulated by CDSCO?

Medical devices covered under the applicable Medical Devices Rules include products used for diagnosis, prevention, monitoring, treatment, life support, disinfection, and other specified medical purposes. 

How are medical devices classified in India?

Medical devices are classified into Class A, Class B, Class C and Class D according to their risk level, from low risk to high risk. 

Do Class C and Class D medical devices need a manufacturing license?

Yes. Class C and Class D devices are subject to the applicable licensing requirements under the Medical Devices Rules, 2017, with the Central Licensing Authority involved in the regulatory process. 

Does ISO 13485 replace BIS or CDSCO approval?

No. ISO 13485 is a quality management system standard and does not automatically replace the applicable BIS or CDSCO requirements. The approvals needed depend on the specific device and regulatory pathway.

Can imported medical devices require approval in India?

Yes. Importers of regulated medical devices must follow the applicable CDSCO requirements. For example, CDSCO identifies Form MD-14 for applications for an import licence, with the licence issued in Form MD-15. 

How long does medical device certification or licensing take?

The timeline depends on the device classification, testing, technical documentation, manufacturing site, inspection requirements, and the applicable regulatory pathway. There is no single timeline for every medical device.

What documents are generally required for medical device compliance?

Documents can include product specifications, manufacturing information, quality management documentation, test reports, technical information, labeling details, risk-related documentation, and other documents depending on the device and applicable regulatory pathway.

Can PSR Compliance help with medical device certification?

Yes. PSR Compliance can assist manufacturers and importers with medical device regulatory evaluation, documentation, testing coordination, BIS-related requirements, CDSCO licensing, and application support based on the applicable product category and risk classification.