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# BIS Foreign Manufacturer Certification Scheme (FMCS): Getting BIS Certification from Outside India

If your product is covered by an Indian Quality Control Order and you manufacture outside India, the FMCS is the only route to hold a BIS licence in your own company's name. Without it, your goods cannot clear Indian customs. The process involves BIS officers visiting your overseas factory — at your expense — and typically takes 6 to 9 months. Starting early is the only strategy. This guide covers every stage from Indian Representative selection through to surveillance audit preparation.

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At a glance

Application office

BIS HQ, Manak Bhavan, New Delhi

IR requirement

Mandatory — India-registered entity

Typical timeline

6–9 months (complete application)

Surveillance frequency

Annual factory visit by BIS

## Key concepts: FMCS structure, IR obligations, and inspection logistics

### FMCS — The Only Route for Foreign Factory Certification in Its Own Name

The BIS Foreign Manufacturer Certification Scheme (FMCS), governed by the BIS Act 2016 and the BIS (Conformity Assessment) Regulations 2018, is the designated mechanism for an overseas manufacturer to hold a BIS licence in its own legal name. The alternative — partnering with an Indian licensee — results in certification being issued to the Indian company, not the overseas OEM. Under FMCS, the foreign manufacturer is the licence holder and bears all obligations including mark control, surveillance, and compliance. FMCS applications are filed with BIS Headquarters at Manak Bhavan, New Delhi — not with any regional office.

### Indian Representative (IR) — Legal Anchor in India

Every FMCS applicant must appoint an Indian Representative — a company or individual with a registered address in India. The IR is not a manufacturing partner or reseller; they are a legal point of contact for BIS. IR obligations include: receiving all BIS correspondence and notices on behalf of the foreign manufacturer, maintaining spare product samples at the IR's Indian address for BIS testing and market surveillance, facilitating BIS inspector visits to the Indian warehousing location, and signing the IR Authorisation Letter which is submitted as part of the FMCS application. The IR can be changed during the licence term by notifying BIS with a new Authorisation Letter.

### Application Office and Document Requirements

FMCS applications are submitted to the Director General (Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002. The application package includes: completed application form with company and factory details, IR Authorisation Letter, copy of factory registration or equivalent from the country of manufacture, detailed product specification and technical file, test reports to the applicable IS standard from a BIS-recognised lab, a documented Quality Assurance Plan covering incoming inspection, in-process control, and final inspection, and proof of payment of the prescribed application fee. Incomplete applications are returned — there is no partial processing.

### Testing Laboratory — BIS-Recognised Labs and MRA Arrangements

Test reports must come from a BIS-recognised laboratory. BIS maintains a list of recognised labs in India. For overseas testing, BIS accepts reports from labs accredited by accreditation bodies with which BIS has a mutual recognition arrangement — check whether your country's national accreditation body (e.g., UKAS in the UK, DAkkS in Germany, A2LA or NVLAP in the US, CNAS in China) has a current MRA with BIS. If no MRA exists, samples must be sent to a BIS-recognised lab in India, or a BIS officer must witness testing at the overseas lab. This determination should be made at the start of the process to avoid late-stage delays.

### Factory Inspection — BIS Officers Come to Your Facility; You Pay

Unlike most certification schemes where a notified body visits the factory, BIS sends its own government officers to conduct the pre-licence factory inspection for FMCS. The foreign manufacturer bears all associated costs — international airfare, hotel, local transport, and per diem for the BIS team. The number of officers is typically 2–3. The inspection covers: factory premises and layout, production process from incoming components to finished product, in-process testing equipment calibration records, final product testing capability, storage and dispatch controls, and the BIS mark application methodology. Prepare all QMS documentation in English. BIS may also request interpreter services at your cost if local language documentation is submitted.

### Licence Grant, Mark Use, and Annual Surveillance Visits

Following a satisfactory inspection, BIS issues a Licence Grant Letter specifying the product, applicable IS standard, licence number, and validity period. The ISI mark or CRS certificate number must be applied to products in accordance with the licence conditions — specific placement, size, and format requirements apply per BIS marking guidelines. The annual licence fee under FMCS is ₹1,000 per product per mark. BIS conducts annual surveillance audits at the overseas factory — again at the manufacturer's cost for officer travel and accommodation. Additionally, BIS or the IR may conduct market surveillance by purchasing products in the Indian market and testing them; failures trigger licence suspension or cancellation.

## BIS FMCS application and certification process

01

Confirm that your product requires BIS certification — identify whether it falls under the ISI Mark scheme (Schedule I mandatory products under the BIS Act 2016) or the CRS scheme (electronics under the BIS Compulsory Registration Scheme Order 2012, administered electronically via the CRS portal). Note the applicable Indian Standard (IS) number.

02

Engage an Indian Representative (IR) — a company or individual registered in India who will sign the IR Authorisation Letter and maintain spare samples at their Indian address. Confirm the IR understands their legal obligations under the BIS (Conformity Assessment) Regulations 2018.

03

Identify the BIS-recognised test laboratory for your product. Check the BIS website for the current list of recognised labs in India and for any MRA arrangements with your country's accreditation body. If your country lab is accepted under an MRA, begin product testing against the applicable IS standard immediately.

04

Conduct pre-testing to the applicable IS standard to identify and correct any non-conformances before the formal application. Prepare a comprehensive technical file including product specifications, circuit diagrams (for electronics), BOM, and a Quality Assurance Plan covering incoming inspection, in-process controls, and final product testing.

05

Submit the complete FMCS application package to BIS Headquarters in New Delhi with all required documents, the IR Authorisation Letter, test reports, and the prescribed application fee. BIS will acknowledge receipt and commence document scrutiny — respond promptly to any BIS queries during this stage.

06

Prepare for and host the BIS factory inspection team. Arrange their international travel, accommodation, and local logistics in advance. Have all QMS documentation, calibration records, and production records ready in English. Brief your production team on the inspection scope and ensure the production line is operating during the visit.

07

Receive the BIS Licence Grant Letter and implement mark use in accordance with licence conditions — place the ISI mark or CRS number on all products, packaging, and documentation as specified. Brief your shipping and logistics team on the licence number to include in customs declarations. Prepare for annual surveillance visits and establish an internal market quality monitoring process.

## Frequently asked questions

### Can a foreign manufacturer get BIS certification without an Indian partner?

Yes — the FMCS exists specifically for this purpose. Under FMCS, the BIS licence is granted in the name of the overseas manufacturer, not an Indian intermediary. The foreign manufacturer must appoint an Indian Representative (IR) to serve as a legal point of contact for BIS in India, but the IR is not a co-owner or co-licensee. The IR receives BIS correspondence and maintains samples — they do not manufacture or sell the product. The certification and all associated obligations belong to the foreign manufacturer. This is distinct from licensing an Indian company to manufacture locally under the BIS scheme, where the Indian company would be the licence holder.

### What is an Indian Representative for BIS FMCS and what are their obligations?

An Indian Representative (IR) is a company or individual registered in India appointed by the foreign FMCS applicant to serve as a legal point of contact for BIS. The IR must sign an Authorisation Letter that is submitted with the FMCS application. IR obligations include receiving all BIS communications and notices on behalf of the foreign manufacturer, maintaining spare product samples at the IR's registered Indian address for BIS market surveillance testing, facilitating any BIS inspector visits to the IR's location in India, and forwarding all BIS correspondence to the foreign manufacturer promptly. The IR cannot be located outside India. Failure of the IR to fulfil their obligations is treated as a failure of the licence holder and can result in licence suspension.

### How long does BIS FMCS certification take?

From the date of submission of a complete application to receipt of the Licence Grant Letter, the FMCS process typically takes 6 to 9 months. This timeline includes: BIS document scrutiny (4–8 weeks), scheduling and conducting the factory inspection (variable — depends on BIS officer availability and the manufacturer's readiness, can add 2–4 months), BIS internal review of inspection report (4–6 weeks), and licence issuance. Incomplete applications, queries that require re-testing, or inspection findings that require corrective action before re-inspection extend this timeline significantly. Foreign manufacturers should initiate the FMCS process as soon as a relevant QCO is notified in draft form — not when it comes into force.

### What happens during a BIS factory inspection of an overseas facility?

BIS sends a team of 2–3 government officers to the overseas manufacturing facility for a pre-licence inspection that typically lasts 2–3 days. The inspection covers: factory premises, layout, and general manufacturing environment; the complete production process from raw material receipt through to finished product; incoming inspection records and supplier quality documentation; in-process quality control points and testing equipment with calibration certificates; final product testing capability and records; storage, labelling, and dispatch controls; and the manufacturer's system for applying and controlling the BIS mark. All costs — airfare, hotel, local transport, and per diem — are borne by the manufacturer. The manufacturer must also cover any witness testing of products during the visit.

**Disclaimer:** Educational resource only. Indian regulatory requirements change frequently. Consult a qualified Indian advocate or compliance specialist before making decisions.

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