On July 11, 2025, the Bureau of Indian Standards (BIS) released detailed guidelines for product certification under Scheme-X of Schedule II in the BIS (Conformity Assessment) Regulations, 2018. These guidelines specifically apply to products governed by the Omnibus Technical Regulation (OTR) issued by the Indian government. Manufacturers seeking to comply with the OTR must follow this certification framework to demonstrate that their products meet essential safety and technical requirements.
Two Certification Types Available
Under Scheme-X, two types of product certification are available:
A license to use the Standard Mark, valid on a continuous basis.
A Certificate of Conformity (CoC), valid only for a specific lot, batch, or prototype.
Applicants must indicate which type of certification they are pursuing when submitting their application using Form-I.
Documentation and Technical File Requirements
Certification is granted based on a comprehensive assessment of a technical file submitted by the manufacturer. The technical file must include:
A full description of the product (types, sizes, grades)
Applicable standards and essential requirements
Product photographs, traceability details, and branding
Design drawings and manufacturing process description
Product Compliance Report, which must cover:
Risk assessment and hazard mitigation
Safety function diagrams (electrical, hydraulic, etc.)
Validation reports for safety-related parts
Supporting documents for any referenced components
In-house quality assurance measures
User manuals and safety instructions
Machinery-specific and component safety standards (Type C, B1, B2), as well as the overarching IS 16819 (Type A), must be referenced depending on the product category.
Multi-Stage Audit and Evaluation Process
Certification involves both desk and site audits. The desk audit verifies completeness of the application and appropriateness of safety standards. The site audit, usually four days long, evaluates the physical implementation of the technical file, manufacturing quality controls, and live safety demonstrations.
Site audits can extend if multiple machines or sites (such as subcontractor locations) are involved. Any discrepancies identified must be resolved before certification is granted.
Initial certification decisions will be made at BIS headquarters, with the Standard Mark license granted for a period of three to six years. For non-compliant applications, BIS provides a rejection notice and opportunity to respond. If deficiencies are not resolved, the application may be rejected.
Foreign Manufacturer Requirements
Foreign applicants must comply with additional rules under the Foreign Manufacturers Certification Scheme (FMCS). This includes appointing an Authorized Indian Representative (AIR), bearing all travel and inspection costs, and submitting physical application documents. Performance Bank Guarantees and legal declarations are mandatory, and the AIR must meet BIS criteria for education and responsibility.
For this article’s source information and any product certification guidance, please contact Global Validity.
Quick Country Facts
India
Certification Body: Ministry of IT and Communications, Wireless Planning & Coordination Wing
Certification Type: Mandatory
License Validity: Indefinite
Application Language: English
Legal License Holder: Local Representative
In-Country Testing Requirement: Testing Not Required
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