Wireless Medical Devices
Fully compliant with WPC framework
Full-funnel services Import, market, operate, and maintain with confidence
Cliniexperts’ service basket for wireless medical devices is as competent as it is comprehensive.
Twenty-five years of proven experience, 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, efficiency, and integrity.
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) arm of the Department of Telecommunications, Ministry of Communications, frames the policies and rules, and regulates the practices of the 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 center” that oversees the end-to-end processes of importing or making, marketing, operating, and upkeep of these products.
More information is available here.
The pre-qualification process
This process is not only complex but also exhaustive, requiring hands-on capabilities to deal with the regulatory dynamics and multi-point contacts. The pre-qualification 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 exhaustive documents involving technical, technological, operational, and marketing aspects
Verifying all documents to be attached for their accuracy
Filling and filing the lengthy application correctly and accurately, ensuring that no ambiguity persists, with the New Delhi head office, or branches at Kolkata, Guwahati, Mumbai, and Chennai.
Importance of ETA
Wireless equipment in India fall under three categories – disposable, consumable, and implantable. An equipment type approval (ETA) is designated by WPC for each type and class of device, which has to be obtained by the manufacturers or importers. Hence, ETA can be compared with a passport that entitles parties to free and easy product market journey.
Equipment Type Approval (ETA)
ETA is a regulatory process where specific types of 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, 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 these numbers comes the confidence that with Cliniexperts, you will be partnering one of the most experienced regulatory services in India, enjoying a leadership position in the industry.
Catering to all client segments. We serve the Indian manufacturers, the Indian importers, and the 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. It 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. Cliniexperts is working diligently to launch a knowledge and information resource section on its website, which will provide all latest regulatory updates on different healthcare sectors. This 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 the 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 ETA grant letter.
Regulatory Body Requirement
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 the 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 can be followed concerning regional RLO involving an application for certification (WPC/ DPL/NDPL/ WPC Import License etc.).
- Step 3: The WPC department issues WPC certificates after the verification of the documents, in the form of Equipment type approval (ETA), Dealer Possession License (DPL), Non-Dealer Possession License (NDPL) and Import License for radio gadgets.
Testimonials
The Brand That Promises To Turn, Your Business Around!
Atomy India Pvt ltd
We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.
Rajeev Rattava
Finance Manager
Morepen Laboratories Ltd.
The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.
Anubhav Suri
Business Head
Proficon Medisol Pvt. Ltd.
We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.
Ajitesh Trehan
Director
Unity Enterprises
We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.
Faiyaz
Founder, Unity Enterprises
Frequently Asked Questions
What is WPC?
WPC stands for the Wireless Power Consortium. It is an industry group or association that develops and promotes the Qi (pronounced "chee") wireless charging standard. The Wireless Power Consortium was founded in 2008 with the goal of creating a universal standard for wireless charging technology.
What is the role of WPC?
The Wireless Power Consortium (WPC) plays a central role in the development, promotion, and standardization of wireless charging technology, specifically the Qi wireless charging standard. Here are the key roles and functions of the WPC:
- Standardization
- Industry Collaboration
- Promotion and Adoption
- Patent Licensing and Fair Access
- Quality Assurance
- Technology Advancement
- Consumer Awareness
- Overall, the Wireless Power Consortium plays a crucial role in shaping the wireless charging landscape, promoting compatibility, and driving the adoption of wireless charging technology worldwide.
Where is WPC Located?
WPC is a global consortium based in the United States. The administrative support of the Wireless Power Consortium is provided by IEEE-ISTO in Piscataway, New Jersey
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.