The Bureau of Indian Standards (BIS) is the National Standards Body of India, responsible for maintaining product quality, safety, and reliability through standardization and certification.
For certain medical devices, BIS registration is mandatory before sale or import in India. This ensures that products meet Indian safety and performance standards under the Compulsory Registration Scheme (CRS) or through ISI Certification.

At Regulant Services, we provide end-to-end support for BIS Registration to help manufacturers, importers, and authorized representatives comply efficiently with Indian regulatory requirements.

Why BIS Registration Is Important for Medical Devices ?

✅ Legal Compliance: Ensures adherence to the Bureau of Indian Standards Act, 2016.

✅ Market Access: Mandatory for listed products before import, sale, or distribution.

✅ Quality & Safety Assurance: Builds trust among healthcare providers and end-users.

✅ Avoid Penalties: Prevents regulatory action or product recall due to non-compliance.

Where Regulant is Pivotal

We provide comprehensive assistance across every stage of the BIS process:

1. Product Assessment

  • Identify applicable Indian Standards (IS) and certification type (ISI / CRS).

  • Verify product classification under CDSCO vs. BIS scope.

2. Documentation Support

  • Preparation and verification of test reports, technical files, and product specifications.

  • Guidance on marking requirements and labeling formats.

3. Testing Coordination

  • Coordination with BIS-recognized laboratories for product testing.

  • Support in addressing queries or test observations.

4. Application Filing & Liaison

  • Online application submission on BIS portal.

  • Communication with BIS officials till license/registration grant.

5. Post-Registration Support

  • Assistance in renewal, surveillance audits, and change management (model updates, manufacturing address, etc.).

Have any questions?

If you have any questions about the therapies, feel free to contact us.

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