India BIS Scheme X Certification: New Voluntary Machinery Safety Guidelines
India: BIS Issues New Scheme X Certification Guidelines as Machinery Safety Certification Becomes Voluntary
On 5 August 2026, the Bureau of Indian Standards (BIS), through its Central Marks Department-I (CMD-I), published the Guidelines for grant of certification as per the conformity assessment Scheme, X of Schedule – II of BIS (Conformity Assessment) Regulations, 2018 (Ref. CMD-I/2:17:1). The document sets out the procedure for granting a licence to use the BIS Standard Mark for machinery safety and supersedes all earlier Scheme X guidelines with immediate effect.
The most significant change is the legal basis of certification. Following the rescission of the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024, BIS confirms that machinery safety certification under Scheme X will henceforth be undertaken on a voluntary basis.
Regulatory Background
In August 2024, India's Ministry of Heavy Industries (MHI) notified the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024 (OTR). The OTR was designed to make BIS Scheme X certification mandatory for a broad range of industrial machinery and electrical equipment before it could be manufactured, imported, or sold in India.
Enforcement was originally scheduled for 28 August 2025 and was later postponed to 1 September 2026. BIS issued its first Scheme X guidelines for OTR products in July 2025. However, on 14 January 2026, the Central Government rescinded the OTR in the public interest through Notification S.O. 239(E), published on 16 January 2026 under Section 16 of the BIS Act, 2016.
The August 2026 guidelines replace the OTR-era procedure and establish Scheme X as a voluntary certification route for manufacturers that choose to demonstrate machinery safety compliance with the BIS Standard Mark.
Key Provisions of the New BIS Scheme X Certification Guidelines
Voluntary scope and eligible machinery
Certification is voluntary. Annexure-I of the guidelines provides an indicative list of eligible machinery categories. Applications for categories not listed may also be accepted, subject to examination by the Central Marks Department-III (CMD-III), which can be contacted at cmd3@bis.gov.in. CMD-III may review and update the list over time.
No. | Machinery Category | Type C Indian Standard(s) | Category-Specific Guidelines |
1 | Pneumatic compressors | IS 17093:2026; IS 11461:2024; IS 12258:2023 | — |
2(a) | Weaving machines (looms) | IS 17361 (Part 6):2020 / ISO 11111-6:2005 | Issued |
2(b)–(c) | Embroidery machinery; knotting machines | IS 17361 (Part 1):2020 / ISO 11111-1:2016 | — |
3(a) | Presses | IS 17277 (Part 1):2019 / ISO 16092-1:2017 | Issued |
3(b) | Electrical discharge machines | IS 17259:2025 / ISO 28881:2022 | — |
3(c) | Turning machines | IS 17258:2019 / ISO 23125:2015 | — |
3(d) | Sawing machines for cold metal | IS 17254:2019 / ISO 16093:2017 | — |
3(e) | Machining centres, milling and transfer machines | IS 17253 (Part 1):2024 / ISO 16090-1:2022 | — |
4 | Rubber and plastics machinery (injection moulding) | IS/ISO 20430:2020 | Issued |
Standards framework
Risk assessment and risk reduction are based on IS 16819 (Type A standard, aligned with ISO 12100). Where available, machine-specific Type C standards must also be applied, supported by Type B1 standards (specific safety aspects) and Type B2 standards (safeguarding devices and components).
Technical file and Product Compliance Report
Certification is granted on the successful assessment of a technical file submitted with the application in Form-I. The technical file must include:
Product description, including variety, grade, type, or size
Applicable specified requirements
Product photographs and traceability details (brand, trademark, date of manufacture, batch or serial number)
Manufacturer's name and complete address
Design details and drawings, to the extent needed to demonstrate safety compliance
Description of the manufacturing process
A Product Compliance Report issued by the manufacturer's own (or sub-contracted) laboratory, covering risk assessment and hazard identification, safety function diagrams (electrical, hydraulic, pneumatic, grounding, stroke limitation), and safety validation reports showing the performance level of safety-related parts of control systems (SRP/CS)
In-house quality assurance measures, inspection and test plans
Instructions for use, installation, maintenance, and safe operation
For safety components referenced in the report, evidence may include a BIS certificate, the original manufacturer's test certificate or datasheet, or a test report from a BIS-recognised/empanelled, accredited, or in-house laboratory. The report must address every identified hazard, categorised as engineering design measures, control system measures, or instruction, labelling, and marking measures.
Desk and site audits
Desk audit: The Branch Office (BO) reviews the application for completeness, including whether the selected specified requirements cover all applicable safety requirements.
15-day window: Queries and shortfalls are communicated along with proposed site audit dates within the next 15 days. The applicant must reply and confirm readiness within that period.
Site audit: Normally four man-days with a team of two auditors, plus two additional man-days for each additional machine. Auditors may require live demonstrations that trigger safeguarding functions, and the audit may extend to sites beyond the factory, such as sub-contracted or final-assembly locations.
Grant at HQ: Initially, all certification cases will be processed for grant at BIS Headquarters, referred by the BO through the Deputy Director General (Regions) to CMD-III.
Grounds for rejection and appeal
Applications may be rejected for reasons including incomplete technical files, confirmed non-conformity, failure to take corrective action on time, unpaid dues, tampered documents (such as misdeclared safety component datasheets), unethical practices, or a safety function failing during site demonstration. BIS must issue a rejection notice of at least 21 days and offer a hearing. Rejected applicants may appeal to the BIS Director General within 90 days, with a fee of INR 2,000.
Foreign manufacturers
Foreign manufacturers must follow the guidelines of the Foreign Manufacturers Certification Department (FMCD). After grant, they must submit a licence agreement and an indemnity bond (on INR 100 non-judicial stamp paper) within 15 days, and a performance bank guarantee of USD 10,000 from a bank with an RBI-approved Indian branch within 45 days.
Fees and concessions
All fees are payable in advance and are published on the BIS website under Conformity Assessment > Scheme-X Certification > Fee. Annexure-V references the BIS notification of 17 March 2026 (Gazette, 30 March 2026), which grants enhanced fee concessions until 31 May 2029: 80% for micro enterprises, 50% for small enterprises, 80% for start-ups, and an additional 10% for women-led micro, small, or medium enterprises.
Certification Impact Summary
Aspect | Under the OTR (2024–2025) | Under the August 2026 Guidelines |
Legal status | Mandatory for listed machinery (never enforced) | Voluntary |
Market access | BIS certification planned as a precondition for sale/import | No BIS certificate required to sell or import listed machinery |
Product scope | Broad OTR First Schedule | Indicative Annexure-I list; other categories on CMD-III approval |
Assessment basis | Technical file, testing, audits | Technical file + Product Compliance Report, desk and site audits |
Grant authority | Regional/Branch Offices | Initially BIS HQ (CMD-III) |
Foreign manufacturer obligations | AIR, agreement, indemnity bond, USD 10,000 bank guarantee | FMCD guidelines; agreement and bond within 15 days, USD 10,000 guarantee within 45 days |
Fee concessions for MSEs | Earlier concession levels | Enhanced concessions until 31 May 2029 |
What This Means for Manufacturers
For machinery manufacturers and importers, the headline is clear: BIS Scheme X certification is no longer a market-entry requirement for the machinery formerly covered by the OTR. Products can be manufactured, imported, and sold in India without a Scheme X licence.
Voluntary certification can still offer commercial value. The BIS Standard Mark provides independent evidence of machinery safety that can strengthen tenders, OEM supply agreements, and customer due diligence, particularly for buyers in public procurement or safety-sensitive industries. Because the process is built on internationally aligned standards such as IS 16819/ISO 12100 and ISO-harmonised Type C standards, manufacturers with existing CE machinery documentation may be able to adapt much of their risk assessment and technical file content.
At the same time, voluntary certification carries real costs: a detailed technical file, multi-day site audits, annual fees, and, for foreign manufacturers, a USD 10,000 bank guarantee. Companies should weigh these costs against customer and market expectations.
Manufacturers should also note that the rescission of the OTR does not remove other BIS obligations. Specific components, electrical equipment, or product variants may still fall under other mandatory Quality Control Orders under Scheme I (ISI Mark) or Scheme II (Compulsory Registration Scheme). A product-by-product and bill-of-materials review remains essential.
Timeline
Date | Milestone |
28 August 2024 | MHI notifies the Machinery and Electrical Equipment Safety (OTR) Order, 2024 |
12 June 2025 | OTR amendment postpones enforcement to 1 September 2026 |
11 July 2025 | BIS publishes the first Scheme X guidelines for OTR products |
14 January 2026 | Central Government rescinds the OTR (S.O. 239(E), published 16 January 2026) |
17 March 2026 | BIS notifies enhanced Scheme X fee concessions (Gazette, 30 March 2026) |
5 August 2026 | BIS issues new voluntary Scheme X guidelines for machinery safety (CMD-I/2:17:1) |
7 August 2026 | BIS updates its Scheme-X Certification Process page with the new guidelines |
31 May 2029 | Enhanced fee concessions for MSEs, start-ups, and women entrepreneurs expire |
Required Actions
Confirm regulatory status. Verify that your machinery is no longer subject to mandatory BIS certification, and check whether components or electrical equipment fall under other active QCOs (Scheme I or Scheme II).
Decide on voluntary certification. Assess whether the BIS Standard Mark provides commercial value with your Indian customers, distributors, or tender requirements.
Check category eligibility. Compare your products against Annexure-I. For unlisted machinery, submit a request for examination to CMD-III at cmd3@bis.gov.in.
Prepare the technical file. Build the Product Compliance Report around IS 16819 and the applicable Type C standard, including risk assessment, safety function diagrams, and SRP/CS validation.
Gather component evidence. Collect BIS certificates, datasheets, or accredited test reports for all safeguarding devices and safety-related components.
Plan for audits. Prepare facilities, personnel, and demonstration scenarios for a site audit of about four man-days, including any sub-contracted or final-assembly sites.
Foreign manufacturers: Review FMCD requirements and prepare the licence agreement, indemnity bond, and USD 10,000 performance bank guarantee in advance.
Budget and claim concessions. Confirm the fee schedule on the BIS website and apply eligible MSE, start-up, or women-entrepreneur concessions before 31 May 2029.
Conclusion
The August 2026 guidelines mark a clear transition for India's machinery sector: Scheme X moves from a planned mandatory regime to a structured, voluntary certification pathway. Manufacturers now have flexibility, but those seeking the BIS Standard Mark must be ready for a rigorous, risk-assessment-driven evaluation. Reviewing product portfolios against Annexure-I and remaining BIS obligations is the best next step.
