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Standards & Regulatory Compliance

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BIS Certification & Regulatory Compliance for Foreign Manufacturers Exporting to India

Any foreign manufacturer whose product falls under a Bureau of Indian Standards (BIS) Quality Control Order (QCO) cannot legally import, distribute, or sell that product in India without valid BIS certification. With over 170 QCOs currently in force covering more than 700 product categories — from electronics and appliances to chemicals, metals, and industrial machinery — most exporters to India encounter a mandatory BIS requirement at some stage. TPM helps foreign producers navigate this process end-to-end: identifying which scheme applies to their product, managing the application and factory-audit process, and maintaining compliance for the life of the licence.

Do You Need BIS Certification to Export to India?

If your product is listed under a Quality Control Order, the answer is yes — regardless of where it is manufactured. Foreign manufacturers must obtain certification under the same conformity-assessment framework as Indian producers, typically through the Foreign Manufacturers Certification Scheme (FMCS). Selling a QCO-notified product in India without a valid BIS licence or registration is a compliance violation, and customs clearance can be denied at the port of entry. We help exporters determine applicability early — before shipment, not after a consignment is held up.

Foreign Manufacturers Certification Scheme (FMCS)

FMCS is the primary route by which an overseas manufacturing facility obtains the right to use the BIS Standard Mark (ISI Mark) on products imported into India. The process includes:

  • Determining the applicable Indian Standard(s) for your product
  • Preparing and submitting the FMCS application through BIS’s online Manakonline portal
  • Coordinating sample testing at BIS-recognised or accepted laboratories
  • Managing the factory audit — BIS officials inspect the overseas facility to verify manufacturing controls, quality systems, and conformity to the Indian Standard
  • Securing the licence and ensuring ongoing surveillance/renewal compliance

We manage this process from application to licence grant, minimising delays that typically arise from documentation errors, incorrect standard mapping, or unprepared factory audits.

Authorised Indian Representative (AIR) Services

Every foreign manufacturer applying under FMCS must appoint an Authorised Indian Representative (AIR) — a legally established entity in India that acts as the official liaison with BIS for the entire duration of the licence. The AIR:

  • Coordinates communication and documentation with BIS
  • Facilitates factory inspections, audits, and surveillance visits
  • Manages licence renewals and corrective-action responses
  • Represents the manufacturer before BIS in the event of non-conformity findings, market complaints, or enforcement action

TPM offers AIR services as an ongoing engagement, giving foreign manufacturers a dependable, accountable presence in India rather than a one-time filing relationship.

ISI Mark / BIS Standard Mark (Scheme-I)

The ISI Mark, granted under BIS Scheme-I, is India’s most widely recognised product-conformity mark and is mandatory for products notified under a QCO. It applies to a broad range of consumer and industrial products — electrical appliances, cement, steel, LPG cylinders, and more. Both domestic and foreign manufacturers must hold a valid Scheme-I licence before using the mark, based on factory inspection and sample testing against the relevant Indian Standard.

Compulsory Registration Scheme (CRS) — Electronics & IT Products

For electronics and IT goods — mobile phones, laptops, adapters, LED products, and 75+ other product categories — BIS uses the Compulsory Registration Scheme (CRS) instead of factory-audit-based licensing. Under CRS, manufacturers test their product at a BIS-recognised laboratory and register based on a self-declaration of conformity, without the recurring factory audits Scheme-I requires. We help foreign electronics manufacturers navigate CRS registration, including recent standard migrations (such as the shift to IS/IEC 62368-1:2023) that require re-certification of existing registrations.

Scheme-X Certification — Machinery & Electrical Equipment

Scheme-X is BIS’s newer conformity-assessment route, introduced for high-risk industrial machinery and electrical equipment under the Omnibus Technical Regulation framework — covering low-voltage switchgear and control gear (circuit breakers, contactors, disconnectors) and machinery categories such as pumps, compressors, transformers, and cranes. It combines a technical-file review with factory inspection and is more rigorous than Scheme-I, reflecting the higher safety stakes of the products it covers. Licences run three to six years. TPM assists foreign machinery and equipment manufacturers with technical-file preparation, application management, and factory-audit coordination for Scheme-X certification.

Standard Formulation Support

Where no Indian Standard yet exists for a product a foreign manufacturer wishes to introduce to India, we assist with the technical submissions and industry consultation process required to get a new Indian Standard formulated by the relevant BIS Sectional Committee — positioning our clients as first movers rather than waiting for standards to catch up to the market.

Our Process

  1. Applicability assessment — confirm whether your product is covered by a QCO and which scheme applies (FMCS/Scheme-I, CRS, or Scheme-X)
  2. Documentation & technical file preparation — compile the manufacturing, quality, and product-conformity documentation BIS requires
  3. Application filing — submit through the relevant BIS portal with correct standard mapping
  4. Testing & factory audit coordination — manage laboratory testing and prepare your facility for BIS inspection
  5. Licence/registration grant — see the application through to certification
  6. Ongoing compliance — AIR representation, renewal management, and surveillance-audit support for the life of the licence

Why Foreign Manufacturers Work With TPM

TPM has operated in India’s trade-regulatory space since 1999, with a 40-plus-member team spanning lawyers, chartered accountants, cost accountants, company secretaries, and engineers. Unlike generalist BIS certification agents, our BIS practice sits alongside deep expertise in Indian customs, anti-dumping, and trade-remedy law — meaning a foreign manufacturer entering the Indian market through us gets both regulatory certification and exposure analysis on trade-remedy risk from a single team that understands how the two interact.

Frequently Asked Questions

Do foreign manufacturers need a physical office in India for BIS certification?
No, but you do need an Authorised Indian Representative — a legally established entity in India — to liaise with BIS on your behalf for the duration of the licence.

How long does FMCS certification take for a foreign manufacturer?
Timelines vary by product and scheme, but factory audits, sample testing, and BIS processing typically extend the timeline for foreign applicants beyond that of domestic manufacturers, given travel and logistics for the audit team. Early preparation of documentation and technical files is the single biggest lever to reduce delay.

What happens if my product is imported into India without valid BIS certification?
Products covered under a QCO cannot be legally imported, distributed, or sold without a valid ISI Mark, CRS registration, or Scheme-X licence, as applicable — customs clearance can be denied and the goods held at port.

What is the difference between CRS and Scheme-X?
CRS applies to consumer electronics and IT goods via lab testing and self-declaration, with no factory audit. Scheme-X applies to high-risk industrial machinery and electrical equipment and requires a factory audit plus a detailed technical file — reflecting the higher safety stakes of the products it covers.

Can TPM represent us if BIS raises a non-conformity or surveillance issue after certification?
Yes — as your Authorised Indian Representative, we manage ongoing communication with BIS, including responses to non-conformity findings, surveillance audits, and renewal filings.

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