India

Capitalizzare le opportunità in India

Regolamenti e requisiti di conformità possono rappresentare sfide per i produttori che si avventurano all'estero. Tali requisiti e le normative sono messe in atto per ridurre i rischi di incidenti, migliorare la qualità della vita e garantire un uso idoneo. La maggior parte dei prodotti che entrano nel mercato indiano deve soddisfare i requisiti delle autorità in base al loro campo di applicazione.

È possibile garantire che i prodotti soddisfano con successo gli standard indiani lavorando con un leader di mercato, TÜV SÜD, un partner che comprende pienamente le esigenze locali e le procedure applicabili in India. Potete contare sulla nostra esperienza e conoscenza per accedere si mercati chiave in modo efficiente, ridurre i rischi, e allo stesso tempo, essere certi della nostra obiettività, integrità e professionalità.

Informazioni di accesso al mercato per categorie

Cliccare sulle barre blu sottostanti per ottenere le informazioni di accesso al mercato per ogni categoria di prodotto.

Electrical Safety - Compulsory Registration Scheme (CRS)

Regulatory agency

  • Department of Electronics and Information Technology (DietY)

Regulations

  • The Compulsory Registration Scheme (CRS) covers 30 types of electronics and information technology goods. 
  • Registered users should use the Standard Mark along with Registration number and IS No.

Guidelines

  • A local representative is required.

CRS PROCEDURE

  • Testing in BIS recognised laboratory.
  • Submit application to BIS.
  • Grant of registration.

Applicable product categories

  • To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indian requirements and obtaining the necessary approval. TÜV SÜD is also able to support manufacturers in attaining the voluntary S Mark under the Safety Certification Scheme operated by STQC.

Electrical Safety - ISI Certification

Regulatory agency

  • Bureau of Indian Standards (BIS)

Regulations

  • The ISI Mark or Standard Mark, is issued by BIS under its certification scheme.
  • ISI certification* is a self-regulation scheme.
  • The scheme itself is voluntary; however, the Government has enforced mandatory certification on various products.
  • While BIS grants licences on application, the enforcement of compulsory certification is done by the notified authorities – in this case, officers appointed by State Government/Central Government.
  • Compliance with ISO Guide 28 and 65.

* Certification procedure and submission requirements differ between foreign manufacturers and Indian importers.

Guidelines

  • A local representative is required.

ISI CERTIFICATION PROCEDURE

  • Submit application with essential documents to BIS.
  • Factory inspection by BIS officer.
  • Sample picking in factory for independent testing.
  • Grant of license.
  • The simplified procedure for ISI certification** requires a submission application with test reports issued by BIS approved test laboratories.

** The simplified procedure is not granted to some items under mandatory certification and all first-time licenses for any product.

Applicable product categories

Product categories requiring BIS registration include:

  • Cables
  • Circuit breakers
  • Electric immersion water heaters
  • Electric irons
  • Electric lamps
  • Electric radiators
  • Electric stoves
  • Switches, etc.

A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indian requirements and obtaining the necessary approval. TÜV SÜD is also able to support manufacturers in attaining the voluntary S Mark under the Safety Certification Scheme operated by STQC.

Environmental

Regulatory agency

  • Bureau of Energy Efficiency (BEE), Ministry of Power

Regulations

ENERGY EFFICIENCY

  • The mandatory energy efficiency Star Label is required for certain products under the Standards & Labelling Program.
  • Requirements for each product are specified in its schedule.

RoHS

  • The Indian government has published E-Waste (Management) Rules, 2016; it's into force from 1 october 2016

Guidelines

  • Manufacturers are required to register themselves for the Standards & Labelling Program and file an e-application for the Star Label.
  • Equipment required to be labelled are listed on the BEE website.

Applicable product categories

  • Product categories under the mandatory energy efficiency scheme include distribution transformers, room air conditioners, frost-free refrigerators and tubular florescent lamps.
  • A full list of product categories may be found here.

To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indian requirements and obtaining the necessary approval. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.

Medical Devices

Regulatory agency

  • Central Drugs Standard Control Organisation (CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

Regulations

  • Some medical devices are regulated under the Drugs & Cosmetics Act 1940, i.e. their treatment is similar to that of drugs/medicines. Such devices require approval from CDSCO.
  • For imported devices, registration and an import license is required.
  • For locally manufactured devices, a grant of license is required after evaluation.
  • For the sale of devices, appropriate sale licenses are required.
  • CDSCO* has uploaded the proposed requirements for future regulatory control of medical devices.

* Under Schedule M-III, the proposed regulation follows the same structure as the EU Medical Device Directive 93/42/EEC. Device classifications A, B, C and D are harmonised with the Global Harmonisation Task Force. The proposed requirements are summarised as follows:

  • Class A and Class B device manufacturers need not obtain a manufacturing license but are required to register with the CLAA. For Class B devices, it is also required that a Notified Body assesses and certifies the manufacturing facility for quality systems.
  • Class C and Class D devices require certification by a Notified Body with regard to design and manufacturing. Manufacturers are then required to apply for a manufacturing license and submit essential documents to CLAA. For Class D devices, it is also required that the manufacturing facility be jointly inspected by CLAA and the state licensing authority.

Guidelines

  • A local representative is required.

IMPORT REGISTRATION REQUIREMENTS 

  • Submission of applicant details and product information.
  • Evidence of approval from other country(s) regulatory agency(s) and related certification if any.
  • Master file (details of Good Manufacturing Practices employed).
  • Post-market surveillance.
  • Undertaking of conformity with respect to requirements in the country of origin.

Applicable product categories

  • A full list of product categories under current regulations may be found here. To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to Indian requirements and obtaining the necessary approvals.

Telecom

Regulatory agency

  • Telecommunication Engineering Centre (TEC), Department of Telecommunications

Regulations

  • Type approval is required to indicate compliance with Generic Requirements (GR).
  • Interface approval is required to indicate compliance with Interface Requirements (IR).
  • Certification of approval is issued against applicants’ own specifications when IR/GR is not available, and in particular cases*.
  • EMC compliance is required for the above, where applicable.

* TEC issues certification of approval in particular cases, specifically for GSM phones, 3G modems, Bluetooth-enabled wireless terminals against approved Standards of Standard Body.

Guidelines

  • A local representative is required.
  • Manufacturers need to submit an application with essential documents and test reports to the respective agencies.
  • Testing for certain products must be performed by in- country test laboratories.

Applicable product categories

  • To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indian requirements and obtaining the necessary approvals.

Wireless

Regulatory agency

  • Wireless Planning and Coordination Wing (WPC), Ministry of Communications and IT, Department of Telecommunications

Regulations

  • Type approval is required for the import of wireless equipment for use in the existing allocated frequency bands.
  • New Frequency Allocation is required for use of wireless equipment in a new frequency band that needs to be allocated.
  • Online filing of all types of license applications is mandatory, followed by hard copy submission of the license application.

Guidelines

  • A local representative is required.
  • Manufacturers need to submit an application with essential documents and test reports to the respective agencies.
  • Testing for certain products must be performed by in-country test laboratories.

Applicable product categories

  • To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

  • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indian requirements and obtaining the necessary approvals.