Equipment Type Approval (ETA) Process – Wireless Technology Devices
Medical devices that contain wireless technology such as cellular, RFID, WiFi, or Bluetooth are subject to regulatory requirements of the Ministry of Communications. Each product must obtain an Equipment Type Approval (ETA) certificate (per device type), and an Import License (per consignment) issued by the Wireless Planning and Coordination (WPC) Wing of the Ministry of Communications.
Note: Receiving-Only products, like GPS only, do not need to seek approval.
Equipment Type Approval (ETA) certificates are required prior to importing any medical products that have radio, Bluetooth, RFID and/or wireless features, into India. ETAs are issued to the Importing Entity by the Wireless Planning and Coordination (WPC) Wing of the Ministry of Communications. Foreign manufacturers will need to work with a local India Agent, like Asia Actual, to apply for and hold the ETAs and Import Licenses.
ETAs are generated for a specific model and are valid in perpetuity. Once approved, they can be used by other parties for the purpose of importation.
Qualifying ETA Products
Any radio equipment (transceiver/active) which operates in a delicensed frequency band will need an ETA.
Additional examples include wireless Bluetooth watches, wireless medical products used for patient profiling laptops, radio frequency identification (RFID) tags and readers, mobile phones or devices, remote key fob entry, wireless headphones and/or earplugs, wireless music players, wireless mouse and keypads, wireless remotes, and any other radio frequency modules.
Asia Actual can assist manufacturers obtain the following certificates from the WPC:
Equipment Type Approval
Dealer Possession License (DPL)
Non-Dealer Possession License (NDCL)
Import License as per the requirement for operating radio products
Average processing time is maximum 30 days from the date of submission of documents in complete. Query may be received for incomplete documents, extending lead time.
Government Fee: INR 10000 per ETA (US$140)
Government Fee = INR 500 per License (US$7)
Average processing time is 30 days from the date of submission. Queries may be received for incomplete documents that could extend the review time.
Validity and Record Keeping
ETA is a certification and therefore, it is valid in perpetuity while Import License are valid for 6-month increments.
As per the conditions of the ETA, records of all imported equipment need to be maintained and submitted to the Ministry, when required. There is also the potential for random inspections to ensure the product is not operating beyond the permissible technical parameters. Importers are also expected to maintain a copy of the ETA certificate as well as the equipment datasheet/brochure for as long as the radios are in use.
The WPC enforces the statutory functions of the Central Government and issues licenses to establish, maintain and operate wireless stations. The WPC is divided into major sections like Licensing and Regulation (LR), New Technology Group (NTG) and Standing Advisory Committee on Radio Frequency Allocation (SACFA). SACFA makes the recommendations on major frequency allocation issues, formulation of the frequency allocation plan, making recommendations on the various issues related to International Telecom Union (ITU), to sort out problems referred to the committee by various wireless users, Siting clearance of all wireless installations in the country etc.
Wireless Planning and Coordination (WPC) Wing of the Ministry of Communications
Currently, there are no additional registrations or approvals needed for medical devices in terms of cybersecurity and/or data privacy in India. Additionally, there is no specific guidance or rules mandating the location of data servers be physically located in India.
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Using Asia Actual as your License Holder in India comes with the added benefit of expertly managed, efficient and transparent importations.
Contact Asia Actual for more information on our Wireless Technology importing services.