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The Indian medical device market is growing rapidly, offering immense opportunities for companies worldwide. However, launching wireless medical products in India requires obtaining mandatory approval called ETA certification from the Wireless Planning and Coordination (WPC) wing of the Department of Telecommunications.
In this blog, I will provide a deep dive into ETA certification — what it means, why it is needed, who needs it, and how companies can secure this license to introduce their wireless medical devices smoothly in the Indian market.
What is WPC?
For starters, WPC was set up way back in 1952 as the National Radio Regulatory Authority under the Ministry of Communications. It is responsible for critical activities like frequency spectrum management, licensing and establishing wireless stations across the country.
Decoding ETA Certification
ETA stands for Equipment Type Approval, which confirms that a particular model of wireless medical device complies with the standards and regulations in India. Devices using wireless technologies such as Bluetooth, Wi-Fi, RFID etc. and operating in frequency bands designated as “license-exempt” by WPC require ETA certification. Without this approval from WPC, wireless medical devices simply cannot be imported, sold or used in India. So, ETA serves as a mandatory green signal that must be obtained before launching any wireless medical product in the country.
Who Needs to Apply for ETA?
Here comes the slightly tricky part. WPC issues ETA certificates only to Indian manufacturers or agencies. Foreign manufacturers have to appoint an authorized Indian agency or local representative that can apply for ETA on their behalf.
Navigating the ETA Application Process
The ETA application involves submitting the form and documents online to WPC’s portal, followed by hard copies to the designated Regional Licensing Office based on the location. For devices operating in de-licensed frequency bands, WPC provides online approval. For others, submissions must be made through the routine process at the regional office. Once submitted, WPC reviews the application and issues the certificate if found satisfactory.
Key Documents Required
When applying for ETA, the following documents need to be furnished:
- Duly completed application form with the medical device’s technical specifications
- RF test reports from a WPC accredited laboratory
- Relevant technical documents like user manuals and design sheets
- Authorization letter from the Original Equipment Manufacturer
- Fee payment receipt of Rs.10,000 per model
ETA Certificates Have Lifetime Validity
Unlike some approvals, ETA certificates do not require any periodic renewals. They are considered lifetime approvals, unless there are changes to the product design or key components.
Self-Declaration Route Available Too
For certain wireless devices like mobile phones operating at very low power in license-exempt bands, WPC offers a simplified self-declaration method for ETA. Applicants can submit undertakings and test reports online for approval after screening.
Conclusion
For medical device companies looking to tap into the flourishing Indian market, acquiring WPC’s ETA certification is a must for wireless products. Partnering with regulatory experts can help navigate this critical approval smoothly and efficiently.
Regulatory Solutions India (RSI) can assist with the entire ETA certification process, CDSCO registration, and all medical device regulatory processes in India. With deep expertise in Indian regulations, RSI ensures hassle-free compliance and approvals to launch your products successfully in the Indian market.
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