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# BIS CRS for Wearables — India Mandatory Certification

Wearable electronics — smartwatches, fitness bands, health monitors, GPS trackers, and hearables — are covered under India's BIS Compulsory Registration Scheme (CRS) when they include rechargeable batteries or wireless radio interfaces. Getting BIS CRS certification for wearables requires navigating mandatory IS standards for lithium batteries and radio interfaces, BIS-recognized laboratory testing, and the BIS online portal registration process.

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At a glance

Scheme

BIS CRS (mandatory)

Key standards

IS 13252, IS 16046 Pt 2

Certificate validity

2 years

Testing timeline

4-8 weeks

Concurrent requirement

WPC ETA (wireless)

## BIS CRS applicability for wearables

The BIS CRS mandatory scope for wearables is triggered by two common product characteristics: rechargeable lithium batteries and wireless radio interfaces. Nearly all modern wearables have both, making BIS CRS mandatory before any sales in India — including products sold through e-commerce platforms or imported for commercial purposes.

### Smartwatches with BT/Wi-Fi and rechargeable battery

**Details:** Smartwatches with Bluetooth, Wi-Fi, or cellular connectivity and a built-in rechargeable lithium battery require mandatory BIS CRS certification under IS 13252, IS 16046 Part 2, and applicable wireless testing standards. This covers the vast majority of smartwatches sold in India.

### Fitness trackers with BT/ANT+ and LiPo battery

**Details:** Fitness bands and activity trackers with Bluetooth or ANT+ wireless connectivity and lithium polymer batteries fall under BIS CRS mandatory scope. The applicable standards are IS 13252 (electrical safety) and IS 16046 Part 2 (lithium battery safety).

### Health monitors — blood glucose, SpO2, ECG with wireless connectivity

**Details:** Wearable health monitors collecting clinical-grade biometric data (blood glucose, SpO2, ECG) require BIS CRS for the hardware's electrical and battery safety, and may additionally require CDSCO medical device registration if the device makes diagnostic claims. Both regulatory pathways must be assessed simultaneously.

### GPS trackers with cellular SIM and hearables

**Details:** GPS trackers using a cellular SIM (personal trackers, child safety devices) require BIS CRS plus WPC ETA for the cellular radio module and potentially TEC MTCTE. TWS earbuds (truly wireless stereo) with Bluetooth require BIS CRS under IS 13252 and IS 16046 Part 2 for the battery safety of both earbud and charging case.

## Mandatory IS standards for wearables

Correctly identifying the applicable IS standards is the first step — and the most consequential. Submitting the wrong scope to the lab results in incomplete test reports that BIS will reject. Most wearables require at minimum IS 13252 and IS 16046 Part 2; wireless and health features add additional standards to the scope.

01

IS 13252 (Part 1): Safety requirements for information technology equipment — the primary electrical safety standard for wearables with USB/wireless charging interfaces. Covers insulation, creepage distances, temperature limits, and protection against electric shock.

02

IS 16046 (Part 2) / IEC 62133-2: Safety requirements for portable secondary lithium cells and batteries used in portable applications. Mandatory for any wearable with an internal lithium-ion or lithium polymer battery — covers overcharge, short circuit, crush, and thermal abuse tests.

03

IS/IEC 62368-1: Audio/video, information and communication technology equipment — safety standard. Applicable to wearables classified as audio or IT equipment (headphones, smart glasses, TWS earbuds). IS 13252 and IS/IEC 62368-1 may both apply depending on product classification.

04

SAR testing: IS/IEC 62209-2 for specific absorption rate (SAR) measurement applies to wearables with RF transmitters worn close to the body. BT and Wi-Fi wearables worn on the wrist or ear require SAR compliance demonstration.

05

WPC ETA for wireless radio: the Wireless Planning and Coordination wing of DoT issues Equipment Type Approval (ETA) for devices using unlicensed wireless spectrum (Bluetooth, Wi-Fi, Zigbee). WPC ETA is a separate requirement from BIS CRS, running concurrently. IS 4691 and ETSI EN 300 328 equivalent tests apply for Bluetooth and 2.4 GHz Wi-Fi.

## BIS CRS certification process for wearables

The BIS CRS process for wearables follows the standard CRS pathway — lab testing, portal application, BIS review, factory inspection, certificate issuance. For foreign manufacturers, the factory inspection requirement is the most commonly underestimated timeline and cost factor.

01

Identify all applicable IS standards based on product classification, wireless interfaces, and battery chemistry. A smartwatch typically requires IS 13252 (electrical safety), IS 16046 Part 2 (battery), and SAR testing — plus WPC ETA concurrently.

02

Select a BIS-recognised test laboratory. NABL-accredited labs listed on the BIS website (bis.gov.in) are eligible. Major labs conducting wearable testing include SGS India, Bureau Veritas India, TUV SUD South Asia, Intertek India, and NABL-accredited government labs.

03

Submit test samples — typically 4-6 units per model variant (colour or strap variants without hardware changes may share test reports; variants with different battery cells or charging ICs require separate reports).

04

Testing timeline is typically 4-8 weeks depending on the lab, standard scope, and current workload. IS 16046 Part 2 battery safety testing involves time-consuming abuse tests (overcharge, short circuit, vibration) that can extend the timeline.

05

Prepare and submit the BIS CRS application on the BIS online portal (manakonline.in). Required documents include: test reports from BIS-recognised lab, product technical documentation, factory quality management certificate (ISO 9001 or equivalent), and application fee payment.

06

BIS officer review of the application takes 15-30 business days. Queries from the BIS officer must be responded to within the stipulated period to avoid application rejection.

07

Factory inspection: BIS conducts a factory inspection at the manufacturing facility before granting the CRS licence. For Indian factories, inspection is scheduled by the BIS regional office. For foreign factories, BIS officers travel to the overseas facility — travel and accommodation costs are borne by the applicant.

08

BIS CRS certificate is issued after successful factory inspection. The certificate is valid for 2 years and must be renewed before expiry. Quarterly sample testing from production batches is required throughout the licence period.

## BIS CRS for foreign manufacturers

The majority of wearables sold in India are manufactured in China or Vietnam. Foreign manufacturers have two practical routes to BIS CRS: appointing an Indian representative as the licence holder, or establishing an Indian subsidiary. The absence of BIS MRAs with major manufacturing countries means testing must always be conducted at a BIS-recognised lab regardless of existing international certifications.

01

Appoint a BIS-authorised Indian representative (most common route): the Indian representative (distributor, subsidiary, or authorised agent) acts as the CRS licence holder and is responsible for all BIS compliance obligations including quarterly testing, BIS correspondence, and factory inspection coordination.

02

Incorporate an Indian entity as the registered party: a wholly-owned Indian subsidiary can apply for CRS directly, which gives the foreign manufacturer full control over the certification without dependence on a third-party representative.

03

BIS Mutual Recognition Agreements (MRAs): BIS does not currently have MRAs with China, Vietnam, or other major wearables manufacturing countries. Test reports from overseas labs are not accepted for BIS CRS — testing must be conducted by a BIS-recognised laboratory, even if the lab is an Indian branch of an international testing company.

04

Foreign factory inspection by BIS officers: BIS officers travel to the overseas manufacturing facility for factory inspection. The manufacturer must provide full access to production lines, quality systems, and component traceability records. All costs (travel, accommodation, per diem) are borne by the applicant and must be arranged and paid before the inspection is scheduled.

05

Documentation required for foreign manufacturer CRS application: factory QMS certificate (ISO 9001 preferred, or equivalent documented quality system), test reports from BIS-recognised lab, authorisation letter appointing the Indian representative, and a product technical file covering design specifications, circuit diagrams, and BOM.

## Frequently asked questions

### Do smart glasses with Bluetooth and cameras need BIS CRS in India?

Yes. Smart glasses with Bluetooth wireless connectivity and a rechargeable lithium battery fall within the BIS CRS mandatory scope under IS 13252 (electrical safety) and IS 16046 Part 2 (battery safety). If the glasses include a camera module, there are no additional BIS standards triggered by the camera alone — but export control and privacy regulations may apply depending on the product's capabilities. WPC ETA for the Bluetooth module is also required concurrently with BIS CRS.

### Can test reports from an international (non-Indian) lab be used for BIS CRS?

No — not directly. BIS CRS requires test reports from a BIS-recognised laboratory. However, many international testing companies (SGS, Bureau Veritas, TUV SUD, Intertek, UL) operate NABL-accredited BIS-recognised labs in India. If you have existing test reports from an international lab that is the parent of an Indian BIS-recognised lab, the Indian branch may be able to review and endorse the tests — but full re-testing is typically required for standards where the Indian IS standard differs from the international equivalent. Confirm with your chosen lab before assuming international test reports can be reused.

### How many models can be covered under a single BIS CRS certificate for wearables?

Each BIS CRS licence covers one product model (one CRS registration number per model). Variants that differ only in colour, strap material, or packaging — without changes to PCB, battery, or wireless module — can sometimes be covered under the same licence with the same test report. However, variants with different battery capacities, charging ICs, or wireless chipsets require separate test reports and separate CRS applications. The BIS officer reviewing the application determines whether variants qualify for a single certificate.

### Does BIS CRS for a smartwatch cover the companion smartphone app or only the hardware?

BIS CRS covers the hardware product only — the smartwatch or wearable device itself. The companion smartphone app is not a physical product subject to BIS CRS. However, if the smartwatch app processes personal data of Indian users, it falls within the scope of the DPDP Act 2023. The hardware and software compliance obligations are separate: BIS CRS for the device, DPDP compliance for the data platform and app.

**Disclaimer:** This page is an educational resource only. BIS CRS mandatory product categories, applicable IS standards, and testing requirements are updated by notification. Always verify current requirements on the BIS portal (bis.gov.in) before commencing certification for your specific product.

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