The document issued by the Bureau of Indian Standards (BIS) dated July 14, 2025, establishes the guidelines for granting certification under "Scheme-X" within the framework of the Omnibus Technical Regulation (OTR), in accordance with the BIS Conformity Assessment Regulations of 2018.

This scheme introduces a specific procedure for the certification of products regulated by the Central Government, with the aim of ensuring technical and safety compliance, based on a thorough documentary analysis and technical audits.

The certification process under Scheme-X contemplates two possible types of certification: a license for the use of the "Standard Mark" with continuous validity, or a "Certificate of Conformity" valid only for a specific batch or prototype. To access this certification, the manufacturer must submit a detailed technical file describing the product's design, manufacture, operation, and compliance with essential requirements. This technical file must include, among other elements, the product description, applicable regulatory requirements, identification photographs, manufacturer data, traceability information, design, manufacturing processes, conformity assessment reports (including risks and mitigation measures), safety diagrams, component certificates, quality control plans, and operating manuals.

WHOM DOES IT IMPACT?

The direct impact is on manufacturers of industrial machinery and electrical/electronic equipment covered under the OTR, foreign companies, importers and distributors, and entities with subcontracted manufacturing models where final assembly or critical parts are performed outside the primary manufacturer's site.

CONCLUSION:

In conclusion, the document marks a structural change in the conformity assessment system for regulated products in India and has a significant impact due to its mandatory nature, technical complexity, and direct consequences for the operations of multiple stakeholders in the industrial sector, both local and international.