BIS Scheme X Certification for Machinery & Electrical Equipment Safety

BIS Scheme X Certification for Machinery & Electrical Equipment Safety

Omnibus Technical Regulation (OTR) – End-to-End Handholding by Praditha Engineers

The Government of India has introduced mandatory safety compliance requirements for a wide range of machinery and electrical equipment through the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order (OTR). Under this regulation, notified machinery and electrical equipment (including assemblies, sub-assemblies and components) must conform to the corresponding Indian Standards and must bear the BIS Standard Mark under Scheme X of BIS Conformity Assessment Regulations.

Praditha Engineers provides complete professional handholding for manufacturers and importers to obtain BIS Scheme X certification and ensure smooth compliance with the Omnibus Technical Regulation requirements.

What is BIS Scheme X Certification?

Scheme X is a BIS conformity assessment scheme applicable to certain products notified under technical regulations / QCOs, where certification is granted based on:

 • Technical File evaluation

 • Product testing (BIS lab / BIS-recognised labs or witnessed in-house testing)

 • Factory / premises assessment

 • Compliance to labelling, marking and safety instructions

BIS provides details of Scheme X and product-specific information through dedicated resources.

Machinery & Electrical Equipment Covered Under OTR

As per the OTR framework, machinery and electrical equipment in scope includes (indicative categories):

Machinery / Mechanical Equipment

 • Pumps for handling liquids and liquid elevators

 • Compressors

 • Thermal treatment machinery (material treatment by change of temperature)

 • Centrifuges, filtering/purifying machinery for liquid and gas

 • Filling, closing, sealing, labelling, packing/wrapping machinery

 • Cranes

 • Construction, earthmoving and mining machinery

 • Weaving machines (looms)

 • Embroidery machinery

 • Metal cutting machine tools

 • Stone/ceramic/concrete/mineral/glass working machinery

 • Rubber and plastics processing machinery

 • Misc. mechanical appliances / machines for public works and buildings

 • Gears, gear boxes, transmission elements, torque converters etc.

Electrical Equipment

 • Rotary electrical machines (generators etc.)

 • Diesel generators

 • Transformers

 • Power semiconductor converters

 • Switchgear and control gear up to 1000V

 • Switchgear and control gear exceeding 1000V

(Exact coverage, HS codes and standards are governed by the notified schedules under the OTR and BIS product specific guidelines.)

Machinery Safety Standards Structure (Type A / Type B / Type C)

Scheme X certification under OTR is aligned with the international safety standards approach:

Type A Standard (General Principles)

 • IS 16819:2018 / ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment & risk reduction

Type B Standards (Generic Safety Aspects)

Includes standards for:

 • guards and guarding design

 • safety distances & minimum gaps

 • emergency stop devices

 • two-hand control devices

 • ergonomics safety signals

 • pressure sensitive mats/edges/bars

 • hazardous substance emission risk reduction (as listed in OTR schedules)

Type C Standards (Machine-specific)

Machine-specific standards override Type A/B provisions when applicable.

Who Needs BIS Scheme X Certification?

BIS Scheme X compliance is relevant for:

 • Indian manufacturers of notified machinery/electrical equipment

 • Foreign manufacturers exporting all notified machinery/electrical equipment to India under Foreign Manufacturers Certification Scheme

 • Importers/Brand owners marketing or selling all notified machinery/electrical equipment in India are required to procure such products only from manufacturers holding a valid BIS Licence.

Certification & Enforcement Authority

The Bureau of Indian Standards (BIS) is the sole authority for:

 • Grant of BIS licence or CoC

 • Market surveillance and enforcement

 • Action against non-compliance

Key Regulatory/Compliance Obligations

Under the notified framework:

 • Every manufacturer of all notified machinery/electrical equipment must obtain BIS License

 • All notified machinery/electrical equipment must meet requirements of relevant Indian Standard, as amended from time to time

 • BIS certification is a pre-condition for sale in the Indian market.

Non-compliance of QCO may result in:

 • Rejection of consignments by Indian Customs for foreign manufacturers

 • Market withdrawal and stop-sale orders

 • Legal action under applicable Indian regulations

 • Any violation of the QCO attracts penalties under the BIS Act, 2016, including seizure of goods and prosecution.

BIS Scheme X Routes: Licence vs Certificate of Conformity (CoC)

Depending on business requirements:

BIS Licence (for regular manufacture)

 • Suitable when manufacturing is continuous

Certificate of Conformity (CoC) (for limited/batch)

 • Suitable when manufacture is not continuous

Both are governed under Scheme X.

Key Requirements for BIS Scheme X Certification

Manufacturers must demonstrate:

 • compliance to applicable Indian Standard(s)

 • product testing evidence (lab-tested or witnessed)

 • robust in-house quality assurance system

 • required labelling, safety instructions, warning symbols

 • availability of technical documentation

Technical File Preparation (Most Critical Part)

Under Scheme X, BIS evaluates a Technical File, which includes:

 • product description (variety/type/size)

 • design drawings / technical specifications

 • applicable standard requirements mapping

 • test reports (independent lab / in-house as applicable)

 • in-house QA plan (incoming, in-process, final tests)

 • inspection & test plan

 • packing/storage controls

 • installation, operation, and safety instructions/manuals

A correctly prepared technical file significantly reduces BIS queries and delays.

Typical Timeline for BIS Scheme X Certification

Time frame varies based on:

 • complexity of product

 • lab testing duration

 • technical file readiness

 • audit scheduling

Many cases can be completed within 45 months once documents and testing are in order (as also reflected in industry norms).

Scheme X Fee Overview (Indicative)

Some commonly applicable BIS fees under Scheme X include:

 • application fee

 • certification fee (annual for licence)

 • technical file review fee

 • inspection fee per man-day

 • sample procurement & testing charges (actual)

(Exact fees are as per BIS Scheme X provisions and current updates.)

How Praditha Engineers Can Help (End-to-End Handholding)

Praditha Engineers provides one-stop expert support for:

Applicability Assessment

 • check whether product is covered under OTR

 • confirm Indian Standards mapping

 • scope definition and certification strategy

Technical File Development

 • drafting and structuring complete technical file

 • design review & compliance mapping

 • operating manuals and safety instruction review

Testing Coordination

 • BIS lab / BIS-recognised lab coordination

 • planning witnessed testing where applicable

 • support for long-duration tests and BIS undertakings (as per provisions)

BIS Registration and Application Support

 • Manakonline/Scheme X application filing

 • query handling and clarification drafting

 • real-time status monitoring

Audit & Inspection Support

 • factory readiness preparation

 • mock audit support

 • guidance during BIS visit and conformity evaluation

Post-Certification Support

We also support after certification for:

 • renewal / surveillance

 • scope expansion / addition of models

 • corrective actions for failures or market surveillance

 • labelling and marking compliance

 • suspension/cancellation related actions

Why Praditha Engineers?

Praditha Engineers is led by Shri M.V.S.D. Prasada Rao, Former Deputy Director General, BIS, with 38 years of expertise in BIS product certification and Foreign Manufacturers Certification Scheme.

 • deep BIS regulatory experience

 • team includes former BIS senior officers

 • practical approach aligned to inspection expectations

 • faster certification with reduced risk of rejections

 • confidential and cost-effective consultancy

 

📧 Email: bis@praditha.com | info@praditha.com

📞 Phone: +91-9885006680 | +91-9866706680

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