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Guidelines for Grant of Certification under Scheme-X for OTR Regulation
For any manufacturer looking to sell products in India, navigating the country's regulatory standards is a critical step. If your products fall under the Omnibus Technical Regulation (OTR), your path to compliance runs directly through the Bureau of Indian Standards (BIS) and its certification framework known as BIS Scheme-X.
This scheme, detailed in the BIS (Conformity Assessment) Regulations, 2018, is designed to verify that products meet India's stringent safety and quality requirements. This guide will walk you through everything you need to know about the Scheme-X certification process, from the initial application to the final grant of license.
What Exactly is BIS Scheme-X?
Scheme-X is the conformity assessment scheme that governs the certification of products covered by specific technical regulations notified by the Central Government. At its core, it’s a system based on the manufacturer's ability to prove conformity through a detailed technical file that is verified by BIS through audits.
Under this scheme, there are two types of certification you can obtain:
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Licence to use Standard Mark: This is a continuous license, granted for an initial period of not less than three years and up to six years. It allows you to apply the BIS Standard Mark to all your production of the certified product.
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Certificate of Conformity: This is a more limited certification. It is valid only for a specific prototype or for a particular lot or batch of a product.
The Cornerstone of Your Application: The Technical File
The entire certification process revolves around the Technical File. This comprehensive set of documents is your primary evidence of compliance, and it must be submitted with your application in Form-I. It is the applicant's responsibility to ensure this file is complete and accurate in all respects.
Your Technical File must include the following details:
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Product Description: Full details of the product, including its type, grade, or variety.
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Product Identification: Clear photographs for easy identification.
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Traceability: Details like brand name, trademark, date of manufacturing, and batch or serial number.
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Design Details: Relevant design drawings that demonstrate safety compliance as per the specified requirements.
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Manufacturing Process: A description of how the product is manufactured.
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Product Compliance Report: This crucial report must cover all applicable safety requirements. It should include a risk assessment, safety function diagrams (e.g., electrical, hydraulic, and pneumatic circuits), and safety validation reports.
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Quality Assurance: Details of your in-house inspection and testing plans and facilities.
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User Instructions: Manuals for the safe installation, operation, and maintenance of the product.
The Audit Gauntlet: What to Expect
BIS verifies your Technical File through a rigorous two-step audit process.
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Step 1: The Desk Audit
First, an officer will conduct a desk audit to scrutinize your application and Technical File for completeness. The officer will check if you have selected the appropriate standards and covered all applicable safety requirements. If any shortfalls are found, they will be communicated to you, and dates for a site audit will be proposed within the next 15 days. You must then submit a reply and confirm your readiness for the site visit within those 15 days. -
Step 2: The Site Audit
A team of normally two auditors will then visit your manufacturing premises for a site audit, which typically lasts four mandays. During this visit, the auditors will:-
Verify the information in your Technical File against your actual processes and infrastructure.
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Ask you to perform demonstrations, such as triggering safety measures in test-use scenarios to observe the outcomes.
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Assess your manufacturing process and quality assurance measures.
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A Special Note for Global Manufacturers: The FMCS
Foreign manufacturers with factories outside India must apply under the Foreign Manufacturers Certification Scheme (FMCS). This scheme has several additional requirements:
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Authorised Indian Representative (AIR): You must nominate an AIR who is an Indian resident. The AIR is responsible for ensuring compliance with the BIS Act and will act as your point of contact.
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Financial Commitments: Foreign manufacturers must bear all travel, accommodation, and related expenses for the BIS auditors from their point of departure in India and back. You are also required to submit a Performance Bank Guarantee (PBG) of US$10,000.
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Consignment Reporting: After receiving certification, you must submit details of all certified goods being shipped to India (including importer details and port of entry) as soon as they are dispatched from your premises.
Understanding the Investment: Fees & Savings
All fees are payable to BIS in advance. The primary fees involved are:
| Fee Type | Fee (in ₹) |
|---|---|
| Application Fee | ₹2,000 |
| Certification Fee (Licence) | ₹25,000 per year |
| Technical File Review Fee | ₹20,000 per technical file |
| Inspection Fee | ₹20,000 per manday |
Also Read: Quality Control Order for Scheme-X
BIS offers significant concessions to support businesses. Enhanced concessions are available until May 31, 2026:
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Micro & Start-up Enterprises: 80% concession on fees payable by large-scale enterprises.
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Small Enterprises: 50% concession on fees payable by large-scale enterprises.
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Women Entrepreneur Enterprises: An additional 10% concession on the fees applicable to their scale (micro, small, or medium).
Navigating Bumps in the Road
If your application has deficiencies, BIS will provide an opportunity to correct them. However, if the issues persist, the application may be processed for rejection. Before any rejection, you will receive a notice of at least 21 days, providing you with a reasonable opportunity to be heard in person or through a representative. Should your application be rejected, you have the right to appeal to the Director General of BIS within ninety days.
WHY USE ABSOLUTE VERITAS (AV) FOR BIS CERTIFICATION?
If you require BIS Registration services, please contact Absolute Veritas. As a leading BIS Registration Consultant, Absolute Veritas assists manufacturers and importers in obtaining timely BIS registration for their products by offering valuable insights and assistance throughout the BIS Registration Process.
Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.
BIS Consulting Company providing BIS Certification services in United States, BIS Certification Services in Italy, BIS Certification Services in Taiwan, BIS Certification Services in Singapore, BIS Certification Services in Turkey, BIS Certification Services in UAE, BIS Certification Services in Germany, BIS Certification Services in Korea, BIS Certification Services in Indonesia, BIS Certification Services in Japan
Absolute Veritas (Bis Scheme X Consultant) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for BIS Certification
For any questions regarding the most recent update on BIS registration licenses, please reach out to us via email at cs@absoluteveritas.com
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Frequently asked questions (FAQ)
What is BIS Scheme X Certification?
BIS Scheme X is a certification program under the BIS Conformity Assessment Regulations, 2022. It ensures that machinery and electrical equipment meet India's rigorous safety and technical standards, ensuring high quality and reliability.
Why is BIS Scheme X Certification necessary?
BIS Scheme X certification guarantees compliance with Indian safety standards, improves product reliability, and is mandatory for certain machinery and electrical equipment under the Omnibus Technical Regulation.
Which products require BIS Scheme X Certification?
Products such as pumps, compressors, cranes, transformers, switchgear, generators, and other electrical and mechanical equipment listed under the Omnibus Technical Regulation require BIS Scheme X certification.
Who needs to obtain BIS Scheme X Certification?
Both domestic and international manufacturers of machinery and electrical equipment intended for sale in India must obtain BIS Scheme X certification to ensure regulatory compliance.
What regulations govern BIS Scheme X Certification?
BIS Scheme X certification is governed by the Bureau of Indian Standards Act, 2016, and the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024.
What is the BIS Scheme X certification process for domestic manufacturers?
Domestic manufacturers must submit documentation, apply for BIS certification, undergo scrutiny, complete a factory audit, test samples, pay applicable fees, and receive the license. The process typically takes 90 working days.
What is the BIS Scheme X certification process for foreign manufacturers?
The process for foreign manufacturers is similar but includes additional steps, such as appointing an Authorized Indian Representative (AIR) and making visa arrangements for factory audits. The process typically takes 6-7 months.
What documents are required for BIS Scheme X Certification?
Required documents include manufacturing details, test reports, quality control procedures, factory layout, and proof of business registration to verify compliance with BIS standards.
How long is the BIS Scheme X certification valid?
The BIS Scheme X certification is valid for 3 to 6 years, with an option for renewal. A Certificate of Conformity (CoC) is issued for one-time production.
Is a factory inspection necessary for BIS Scheme X Certification?
Yes, a BIS-appointed auditor will conduct an on-site factory inspection to verify that safety and quality standards are being met.
What are the testing requirements for BIS Scheme X Certification?
Products must undergo testing in BIS-approved laboratories or in-house labs. The test results will be verified during the factory inspection.
What fees are involved in the BIS Scheme X certification process?
The BIS Scheme X certification fees include an application fee, testing charges, audit fees, and a marking license fee as outlined by BIS regulations.
How does BIS Scheme X certification benefit manufacturers?
BIS Scheme X certification boosts product credibility, ensures compliance with Indian regulations, expands market opportunities, and enhances consumer trust.
What happens if a product fails the BIS testing?
If a product fails BIS testing, the manufacturer must correct the issues, reapply for testing, and submit a fresh application if required.
Who can assist with obtaining BIS Scheme X Certification?
Certification consultants like Absolute Veritas provide expert assistance with documentation, application processing, and regulatory compliance to ensure a smooth BIS Scheme X certification process.
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