Wireless Medical Devices
End to End WPC Framework Compliance for Medical Devices in India
Full-funnel services Import, market, operate, and maintain with confidence
Cliniexperts’ service basket for wireless medical devices is as competent as it is comprehensive.
With twenty-five years of proven experience in handling regulatory affairs, we assure you start-to-finish project partnership, a dedicated team accessible 24/7, up-to-the-minute knowledge of regulatory affairs, regularly updated progress reports, timely completion of processes including licenses and approval, and much more.
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Obtaining Dealer Possession License from WPC |
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Non-Dealer Possession License (DPL) |
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Equipment Type Approval (ETA) from WPC |
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Import License |
Partner with CliniExperts, and get the advantage of Experience, Expertise, and Efficiency
About WPC and Wireless Devices?
Wireless technology is transforming healthcare practices globally. Its disruptive solutions such as wearable devices, smart patient tags, connected implants, and IoT-enabled equipment are changing the diagnosis, treatment, and after-care regimes. Its main advantages are improved accuracy, efficiency, and outcomes.
Like any other technology product, the wireless medical devices market needs a federal agency to govern its ethical and professional conduct. In India, the Wireless Planning and Coordination (WPC) an arm of the Department of Telecommunications, Ministry of Communications, frames the policies and rules, and regulates the practices of the wireless medical devices market. Its authority spans the approval, licensing, operation, and maintenance of devices using wireless technologies such as RFID, WiFi, mobility technologies, and Bluetooth. As such, WPC is the “command centre” that oversees the end-to-end processes of producing or importing marketing, operating, and upkeep of these products.
More information is available here.
The Pre-qualification Process
The pre-qualification This process is complex and exhaustive, requiring hands-on capabilities to navigate egulatory dynamics and multi-point contacts. This process requires these processes to be completed within 30 to 40 days:
Preparation and review of the radio frequency exposure report by a competent authority
Preparation of comprehensive documents covering technical, technological, operational, and marketing aspects.
Verification of all documents to be attached for accuracy.
Accurate completion and submission of the lengthy application to the New Delhi head office, or its branches at Kolkata, Guwahati, Mumbai, and Chennai to ensure no ambiguity persists.
Importance of ETA
Wireless equipment in India falls into three categories: disposable, consumable, and implantable. WPC designates an equipment type approval (ETA) for each type and class of device, which must be obtained by the manufacturers or importers. Hence, ETA can be compared with a passport that entitles parties to a free and easy product market journey.
Equipment Type Approval (ETA)
ETA is a regulatory process where specific types of wireless equipment are assessed and authorized by relevant authorities to ensure their compliance with safety and technical standards before they can be legally sold or operated in a given jurisdiction.
Dealer Possession License (DPL)
A DPL is a license granted to authorized dealers, allowing them to possess, store, and sell certain controlled goods or products. It is often subject to regulations that ensure proper record-keeping, reporting, and adherence to legal guidelines.
Non Dealer Possession License (NDPL)
NDPL is a license that permits individuals or entities who are not dealers to possess certain controlled items, provided they meet the necessary criteria and adhere to the prescribed rules and regulations governing the possession and use of these items.
License/Demonstration/ Manufacturing & Testing License
This multifaceted license covers various activities such as demonstrating, manufacturing, and testing controlled items. It authorizes entities to showcase, produce, and assess the performance of these items under specific guidelines and supervision.
Import License from RLO
An Import License obtained from a Regulatory Licensing Office (RLO) is a legal document allowing individuals or businesses to import specific goods into a country. This license often requires compliance with customs regulations, safety standards, and other relevant laws to ensure responsible and lawful importation.
Experimental Approval
Experimental Approval by the Wireless Planning & Coordination (WPC) in India refers to the permission granted to individuals, organizations, or entities to conduct experimental activities involving wireless communication equipment or technologies.
Why Choose CliniExperts?
Over _____ Client Mandates Fulfilled: With over 15 years of successful experience in the regulatory industry, handling all sorts of documentation, building strategic workflow, streamlining applications for timely approvals, licensing, and providing successful clinical trial solutions, CliniExperts assures in-depth analysis and customised solutions to enhance your product offerings seamlessly.
Catering to all Client Segments: Our clientele range from Indian manufacturers and Importers to overseas players wishful of India entry. Regardless of your segment of operation, we have competent talent to handle your portfolio to your utmost satisfaction.
Benefit of Binary Services: t is mandatory that overseas manufacturers work with a local Indian partner to procure product ETAs, as well as get an import license for their Indian agent. CliniExperts can serve you in both ways – as your Indian regulatory arm and your local agent. Hence, you get integrated services under one roof.
The Power of Knowledge: Besides regulatory affairs matters, CliniExperts diligently provides to launch a wealth of knowledge and information its website, providing all the latest regulatory updates on different healthcare sectors, includes the wireless medical devices vertical. Hence, you will be able to access this knowledge from anywhere, anytime, in real time!
Form Names: N/A
ETA Approval
Medical devices that contain wireless technology such as cellular, RFID, WiFi, or Bluetooth are subject to regulatory requirements of the Ministry of Communications and require to obtain a license from the Authority. If the product falls in the De-license frequency band, ETA approval would be required. Subsequently, the import license is to be separately obtained by the importer based on the ETA grant letter.
Regulatory Body Requirement
The Following are the documents required for the ETA Approval:
- Business owner photo ID proof of owner
- Business owner address proof
- Proof of possession of premises
- Company documents such as company incorporation documents or partnership deed
- Radio Frequency Exposure Report (RF Report)
- Product technical guide or user manual
- The major documents for Import License (IL) approval:
- ETA Certificate
- Proforma Invoice
- Purchase Order
How to Apply
The following steps need to be followed for the application process:
- Step 1: An online application and a hard copy of the application must be submitted to the WPC department office.
- Step 2: Equipment working in a license-free frequency band must undergo an online procedure. Otherwise, a routine process concerning regional RLO involving an application for certification (WPC/DPL/NDPL/WPC Import License, etc.) can be followed.
- Step 3: The WPC department issues WPC certificates after the verification of the documents, in the form of Equipment Type Aapproval (ETA), Dealer Possession License (DPL), Non-Dealer Possession License (NDPL) and Import License for radio gadgets.
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Frequently Asked Questions
What is WPC?
WPC or the Wireless Planning & Coordination is an Indian regulatory body, under the Ministry of Communications, responsible for overseeing Radio Frequency (RF) spectrum and regulating the licensing of all wireless devices operating in Indian market.
What is the role of WPC?
The Wireless Planning & Coordination (WPC) plays a central role in the development, promotion, and standardization of wireless technology. It oversees the licensing and regulation of all wireless medical devices, such as Wi-Fi, Bluetooth, and other radio-based technologies, operating within India. With the use of radio frequency spectrum, it manages interference between different wireless devices.
Where is WPC Located?
WPC has five Regional Licensing offices spanned in India: at New Delhi, Mumbai, Kolkata, Chennai & Guwahati.
Who can be the applicant of ETA Approval?
The WPC certificate is granted only to the Indian agencies. Any foreign manufacturer that requires the approval must appoint an Indian authorised agent for the same and submit the authorisation letter stating the same with Authority.
What are the applicable conditions for the ETA Self declaration application?
ETA through self-declaration applies to the products that meet two conditions: - exempted from import licensing requirements as per the Export and Import (EXIM) Policy of DGFT - operation in the de-licensed frequency band(s) as per applicable Gazette Notifications Therefore, these products may be imported by submitting a self-declaration to Customs as per ETA approval.
Is the import of wireless modules (not finished product) allowed under self-declaration?
Yes. The import of wireless modules is allowed under self-declaration if a wireless module is exempted from licensing requirements in the Export and Import (EXIM) Policy of DGFT.
What RF test Report is required for obtaining ETA?
The Accredited Laboratory issues the RF test report for the product that requires the issuance of ETA. If the imported product has multiple RF modules, then all RF modules test report(s) must be uploaded without any alteration.
Can ETA be utilised by persons other than the applicant for import without fees?
Yes. Once ETA is issued for a product through Self-Declaration or RLO, other than the applicant, anyone can utilise it for import without any additional payment.