Independent BIS consultants. Not affiliated with the Bureau of Indian Standards.
Complyr
← All guides

FMCS for Foreign Manufacturers: Step-by-Step Guide — India 2026

10 min read

The Foreign Manufacturers Certification Scheme (FMCS), also known as BIS Scheme II, is the mandatory certification path for any overseas manufacturer whose products are subject to a Quality Control Order (QCO) and must be sold or imported into India. Without FMCS certification, those products cannot legally enter the Indian market. This guide explains who needs FMCS, how the process works, what it costs, and how to avoid the most common pitfalls.

Who Needs FMCS Certification?

Any manufacturer located outside India that wants to export products to India that are covered by a mandatory QCO must obtain an FMCS licence from BIS. The ISI Mark — required under those QCOs — can only be granted to foreign manufacturers via the FMCS route.

This affects manufacturers in China, Korea, Japan, the EU, USA, and every other country exporting regulated products to India. Common product categories include steel, electrical goods, chemicals, cement, electronics (though most electronics use CRS instead), and safety equipment.

  • Check whether your product's HS code appears under a QCO at bis.gov.in or the Complyr QCO Tracker
  • If covered by a QCO, FMCS is mandatory — there is no exemption for size of shipment or company size
  • Voluntary FMCS is possible for non-QCO products to differentiate in the Indian market
  • CRS (Compulsory Registration Scheme) — not FMCS — applies to electronics and IT products; check which scheme applies to your product

Appointing an Authorised Indian Representative (AIR)

BIS requires all FMCS applicants to appoint an Authorised Indian Representative (AIR) — a legal entity registered in India that acts as the interface between the foreign manufacturer and BIS. The AIR signs the application, receives BIS correspondence, is responsible for ensuring ongoing compliance, and can be held liable under Indian law.

The AIR must be a company or individual registered under Indian law — it cannot be a foreign entity. Complyr offers AIR services as part of our FMCS consultancy. Alternatively, you can appoint your Indian importer, distributor, or a subsidiary if one exists.

Note: Choosing the right AIR is critical. The AIR's reputation with BIS, their familiarity with your product category, and their responsiveness to BIS queries directly affect the speed of your certification.

The FMCS Application Process

The FMCS process is more complex than domestic ISI Mark certification because it involves an overseas factory inspection by a BIS officer — at the applicant's expense.

  • 1. Eligibility and IS identification — Confirm the applicable Indian Standard, QCO coverage, and product scope
  • 2. AIR appointment — Sign and register an AIR agreement with an India-registered representative
  • 3. Application submission — File Form II with BIS, including factory details, product specifications, quality system documentation, and initial lab test reports
  • 4. BIS acknowledgement and fee payment — Pay the BIS application fee and inspector's overseas travel cost deposit
  • 5. Overseas factory inspection — One or two BIS officers travel to your facility. The inspection covers production capacity, in-house testing, raw material controls, and product marking readiness
  • 6. Lab testing — Samples may be tested at a BIS-recognised lab in India (or occasionally at an overseas lab with prior BIS approval)
  • 7. Licence grant — BIS issues the FMCS licence. Products may now be imported and sold in India with the ISI Mark
  • 8. Annual renewal and surveillance — Licence is renewed annually; BIS may conduct follow-up inspections

Preparing for the BIS Factory Inspection

The overseas factory inspection is the most critical — and most frequently underestimated — step in FMCS. BIS officers evaluate your facility against the requirements of the applicable IS standard, not just general quality management principles.

Key areas assessed during inspection include: production process controls, in-house testing equipment (must match IS requirements), raw material traceability, product sample results, and your quality manual.

  • Review all testing requirements in the applicable IS standard — every listed test parameter should have a matching in-house instrument or a documented lab outsourcing procedure
  • Prepare a factory layout plan, equipment list, and calibration certificates in advance
  • Train QC staff on IS test methods — BIS officers may ask staff to demonstrate testing
  • Ensure product packaging and marking are ready to display the ISI Mark format (even before licence is granted, mock-ups help)
  • If any non-conformances are found, BIS issues a deficiency report — you typically have 60 days to submit corrective action evidence
Note: BIS officers' travel and accommodation costs are borne by the applicant. For most countries, this adds ₹1,50,000–₹3,00,000 to the total certification cost.

Timeline and Costs

FMCS is the most time-consuming BIS certification route. The single biggest variable is scheduling the overseas factory inspection — BIS has a limited pool of officers and a large inspection backlog.

  • End-to-end timeline: 6–12 months (occasionally longer for complex standards or high-demand inspection seasons)
  • Application fee: ₹18,000–₹25,000
  • BIS officer overseas travel deposit: ₹1,50,000–₹3,00,000 (refunded in part if actual costs are lower)
  • Lab testing: ₹20,000–₹1,00,000 depending on IS standard and number of models
  • AIR fee: variable (typically ₹50,000–₹1,50,000/year)
  • Start the process 9–12 months before your intended import date to avoid supply chain disruption

Common Reasons FMCS Applications Are Delayed

Having supported dozens of FMCS applications, these are the most frequent causes of delays:

  • Incomplete application — missing quality manual, incomplete factory layout, or missing test reports for all IS parameters
  • Lab reports from non-BIS-recognised labs — always verify the lab's BIS recognition status before testing
  • In-house testing gaps — factory does not have equipment for all tests required by the IS; must either procure or arrange outsourcing
  • AIR not registered or agreement not in BIS-prescribed format
  • BIS inspection scheduling backlog — nothing can be done to accelerate this except applying early
  • Post-inspection deficiency report not responded to within the deadline

Key Takeaways

  • FMCS (BIS Scheme II) is the only legal path for foreign manufacturers whose products fall under a QCO
  • An Authorised Indian Representative (AIR) — a registered Indian entity — is mandatory
  • The overseas factory inspection by BIS officers is the critical bottleneck; budget 9–12 months lead time
  • Inspector travel costs are borne by the applicant and can add ₹1.5–3 lakh to the total cost
  • Start early — FMCS delays are among the most common causes of QCO non-compliance by importers

Need help with certification?

Fixed-fee, end-to-end support. Tell us your product and we will confirm the right scheme.