BIS Issues Guidelines for Grant of Certification under Scheme-X for OTR Regulation

The Bureau of Indian Standards (BIS) has officially released comprehensive guidelines for granting certification under Scheme-X for products covered under the Omnibus Technical Regulation (OTR). These guidelines, approved by the Competent Authority, aim to standardize the certification process, ensuring that all safety and compliance requirements are met for machinery and related products.

Key Highlights of the Guidelines

1. Dual Certification Options Available

Under Scheme-X, BIS offers two types of certifications:

• Licence to Use the Standard Mark for continuous product conformity.
• Certificate of Conformity (CoC) valid for a specific prototype, lot, or batch.

2. Application & Assessment Process

• Applications must be submitted using Form-I along with a comprehensive Technical File.
• The certification process includes a desk audit followed by a site audit to verify the product's compliance with safety and technical standards.

3. Technical File Requirements

Manufacturers must submit detailed documentation including:

• Product description, specifications, and photographs
• Safety validations, design drawings, and risk assessments
• Test reports from recognized or accredited labs
• In-house quality assurance and manufacturing process details

4. Emphasis on Safety Compliance

The guidelines refer to IS 16819 and other relevant standards to ensure effective risk assessment and reduction, especially for machinery. BIS also provides machinery-specific guidance documents to support applicants.

5. Audit and Evaluation

Site audits are typically conducted over four man-days and may extend based on the number of technical files or complexity of the product.

• The audits cover manufacturing processes, quality controls, and live demonstrations to assess safety functionalities.

6. Foreign Manufacturer Requirements

Foreign entities must comply with additional requirements under the Foreign Manufacturers Certification Scheme (FMCS), including appointment of an Indian Authorised Representative (AIR), execution of performance bank guarantees, and facilitating sample testing and inspections.

7. Certification Validity and Rejection Protocols

• Licences under Scheme-X are granted for 3 to 6 years.
• Applications may be rejected if deficiencies are not resolved despite opportunities given. A 21-day notice period is provided before final rejection.

8. Fee Structure

All fees must be paid in advance. The latest fee schedule is available on the BIS website under Scheme-X Certification.

Why This Matters

These guidelines are crucial for manufacturers—both domestic and international—who are looking to bring OTR-regulated products into compliance with Indian standards. By aligning with BIS's structured approach under Scheme-X, manufacturers can ensure market access, consumer trust, and legal conformity.

Need Help with Scheme-X Certification?

Our team at Aleph India specializes in end-to-end assistance with BIS certifications. Whether you’re preparing your technical file, coordinating with labs, or navigating the FMCS route—we’re here to help.
Contact us today to begin your certification journey with confidence!