BIS Certification under Scheme X launched – New Information on Implementation and Open Questions

16. July 2025

On July 11, 2025, the Bureau of Indian Standards (BIS) published binding requirements for the new certification procedure “Scheme X” for the first time. These requirements apply to a wide range of products, including various production machines and systems, as well as pumps, motors, filters, and other technical equipment. As of now, these products will require BIS certification under Scheme X starting in September 2026 to be imported into and sold in India.

Technical Basis

Two certification pathways have been confirmed:

• Type Approval for series production
• Certificate of Conformity (CoC) for one-off items or prototypes

The conformity assessment is based on standard IS 16819, which is fully harmonized with the EU Machinery Directive, including Type A, B, and C standards. Assessment is carried out through a factory inspection and evaluation of documents submitted during the application process.

Requirements for Technical Files and Product Compliance Report

The Product Compliance Report is a mandatory part of the technical documentation and must cover the following key safety aspects:

• Risk assessment
• Description of core safety functions
• Safety validation

It must also document risk mitigation measures, including:

• Technical design
• Control systems
• Warnings, labeling, and user instructions

In addition, the requirements for the Technical Files match those previously communicated by the authority.

If additional documents are requested, the applicant has 15 days to respond, and BIS commits to replying within the same period.

Audit Requirements

The standard audit covers four man-days with two auditors. Additional man-days may be required for reviewing further technical documents. If final assembly does not take place at the manufacturing site, the final assembly location must also be audited.

During the audit, safety functions must be demonstrated, and the manufacturing process and quality assurance system must be presented in detail.

The certification is valid for three to six years, depending on the product category.

Open Questions

1. Certificate of Conformity (CoC):
   • How exactly does the CoC process differ from Type Approval?
   • What are the requirements for applying for a CoC?
2. Factory Audit in Case of Product Expansion:
   • Are new audits required when variants are added later? This is not currently expected but not officially defined.
   • When is a follow-up product considered an auditable extension? Likely when products of a different category are added to an already certified site.
3. Product Compliance Report:
   • Is there a required format or minimum content?
   • Is a freely structured report acceptable as long as all content is included?
4. Audit Duration:
   • Does “4 man-days with two auditors” mean two calendar days with two people, or four days with both auditors present?
5. Final Assembly at the Customer Site in India:
   • Will an additional on-site audit be required at the customer’s location if the final assembly is done there?
6. Certification Validity:
   • Can the maximum six-year validity be applied for directly, or is a step-by-step approach required?
7. Role of the Authorized Indian Representative (AIR):
   • What specific responsibilities does the AIR have according to Annex 4 regarding test coordination, even though product testing is not generally required?

Other Unresolved Issues

• Product Scope:
  Is the current HS code-based definition of certifiable products sufficient? How are borderline cases handled where the function is the same but the HS code differs?
• Duration of the Procedure:
  How long does the entire process, including audit and final approval, usually take?
• Extension/Modification:
  Are there simplified procedures for product modifications or range extensions?

Download Information

You can download an information overview sheet as free PDF here.

If you would like to know which approval requirements apply to your products in India or want to stay informed about the latest certification regulations, please do not hesitate to contact us by email or phone (Europe: +49-69-271 37 69 261, US: +1 773 654-2673). If a certification need is discovered we can provide a quotation to make sure that all your certification needs are covered.

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