BIS / Scheme X

BIS Scheme X OTR Certification

BIS Scheme X Compliance for Machinery & Electrical Equipment

Expert consultancy for end to end BIS Scheme X OTR certification, product compliance, technical documentation, testing coordination, application submission, coordination with BIS officials, query reply and conformity assessment for eligible machinery and electrical equipment manufactured in India or abroad.

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At a Glance

AuthorityBureau of Indian Standards
Timeline2 to 3 months
Mandatory?Yes — Notified Products
Applies ToDomestic & Foreign Manufacturers
Initial Validity3 Years
Factory AssessmentRequired
✅3 Years Initial Validity
✅Up to 6 Years on Renewal
✅7 Certification Steps
✅HSN Based Coverage
Service Overview

What is BIS Scheme X OTR Certification?

BIS Scheme X certification is a conformity assessment framework established under the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. It provides a route for assessing specified products, including machinery and electrical equipment, against applicable Indian Standards and prescribed technical requirements. Whether certification is mandatory depends on the relevant Quality Control Order (QCO), notification, product category, and applicable regulatory provisions.

As per the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024.Manufacturers should verify the current regulatory position before determining whether a product falls under the former OTR framework or another applicable compulsory certification requirement. Scheme X also covers products subject to separate applicable requirements, including certain electrical equipment under relevant Quality Control Orders.

Eminence Global Compliance Group provides BIS Scheme X consultancy for domestic and foreign manufacturers. We assist with regulatory applicability assessment, identification of relevant Indian Standards, documentation, testing coordination, application preparation, and coordination throughout the applicable BIS certification process.

Why this certification matters

  • Compliance is compulsory for notified products
  • Uniform safety and quality benchmarks across industries
  • Multiple product categories covered under one framework as per HSN code
  • Strengthens consumer protection
  • Ensures only compliant products enter the Indian market

Applicable Industries

Domestic Machinery & Equipment ManufacturersForeign Manufacturers Exporting to IndiaMachinery Covered under the Former OTR FrameworkElectrical Equipment ManufacturersPumps, Compressors & Fluid Handling EquipmentConstruction, Mining & Earthmoving MachineryIndustrial Processing & Packaging MachineryMetalworking Machines & Machine ToolsMachinery Assemblies, Sub-Assemblies & ComponentsManufacturers Seeking Voluntary BIS Scheme X CertificationManufacturers Requiring Machinery Safety CertificationMulti-Product Manufacturing Companies

Certification Details

SchemeBIS Scheme X – OTR
Issuing BodyBureau of Indian Standards
Applicable StandardsIS 16819:2018 / ISO 12100:2010
Coverage BasisHSN Code
Pre-Market ApprovalBefore Manufacturing
Factory AssessmentRequired
Initial Validity3 Years
On RenewalUp to 6 Years

Our Track Record

3

Years Initial Validity

Up to 6

Years on Renewal

7

Certification Steps

HSN

Based Coverage

How It Works

Our Step-by-Step Process

A structured, transparent journey from your first enquiry to receiving your BIS / Scheme X approval.

01
📋

Product Applicability Assessment

Identify the machinery or electrical equipment category, applicable Indian Standards, and relevant safety requirements under BIS Scheme X, including voluntary machinery safety certification associated with the former OTR framework.

02
📄

Technical File Preparation

Compile the technical file containing product specifications, design and manufacturing details, risk assessment, applicable safety measures, and the Product Compliance Report.

03
🔬

Product Conformity Evaluation & submission of application

Evaluate the product against applicable Indian Standards and specified safety requirements, including relevant type A, type B and type C standards, as applicable and submission of application on BIS Portal.

04
🔍

BIS Technical File Review

BIS reviews the submitted technical documentation and Product Compliance Report through the applicable assessment process, including desk audits.

05
🏭

Site Assessment

BIS conducts a site audit at the manufacturing premises, where required, to assess compliance with the applicable certification requirements.

06
✅

Grant of Certification

Following satisfactory assessment and closure of applicable observations, BIS may grant a licence to use the Standard Mark or issue a Certificate of Conformity (CoC), depending on the certification route.

07
🔄

Ongoing Compliance

Maintain product safety documentation and fulfil the applicable certification conditions, surveillance requirements and other obligations associated with the granted licence or certificate.

Why It Matters

Key Benefits of BIS Scheme X OTR Certification

More than a legal requirement — it's your commercial passport to the Indian market.

🧩

Single Framework

Multiple product categories are covered under one regulation as per HSN code, which simplifies regulatory coverage.

🌏

Market Access

Compliance with OTR is required to place notified products in the Indian market.

🛡️

Consumer Protection

The regulation sets consistent safety and quality benchmarks that protect consumers.

📏

Uniform Benchmarks

The same safety and quality standards are enforced consistently across industries.

⏳

Longer Validity

Certification starts with a 3-year validity and can be extended up to 6 years at renewal.

🧭

Clear Compliance Path

A structured regulation makes it easier to understand what you need to comply with.

Preparation Checklist

Documents Required

Gather these before your application. Our team will review and complete any gaps.

Company & Legal Documents

Business Registration and Legal Documents
Business license of factory (for foreign manufacturers)
Manufacturing Process Details
GST Certificate
MSME Certificate
Factory Layout and Production Capacity
Details of Authorised Indian Representative (for foreign manufacturers)

Technical & Compliance Documents

Product Specifications and Drawings
Quality Control and Assurance Documents
Technical File (including multiple documents)
Risk Assessment Report
Process flow chart along with description
Test Reports (if available)
Other technical documents

Note: The technical file is made up of several documents and needs to be prepared carefully. Our specialists confirm whether your product falls under OTR and prepare the complete set before filing.

Common Questions

Frequently Asked Questions

Can't find what you're looking for? Our experts are happy to answer.

Ask Our Experts

Manufacturers of products notified under the regulation, including domestic manufacturers and foreign manufacturers exporting to India.

Certification is required before manufacturing the product, as OTR is a pre-market approval.

Initially for 3 years as per BIS guidelines. At renewal, it can be extended up to 6 years.

Yes. BIS officials inspect the manufacturing facility to verify manufacturing and safety systems and our expert shall be available on-site during Audit to manage the complete Audit/Inspection.

Yes. Foreign manufacturers need to provide details of an Authorised Indian Representative along with their application. Eminence Global Compliance Group can act as a AIR on behalf of your company.

Start Today

Get Your BIS Scheme X – OTR (Omnibus Technical Regulation) Licence

Planning to obtain a BIS Scheme X licence for machinery or electrical equipment under the Omnibus Technical Regulation (OTR) framework? Eminence Global Compliance Group supports domestic and foreign manufacturers with LVSG (Low voltage switchgear) and OTR applicability assessment, technical documentation, product testing coordination, factory assessment preparation, on-site audit/inspection support, coordination with BIS officials and BIS certification procedures. Contact our team to understand the applicable certification route and requirements for your products.

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