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About ELT Corporate
ELT Corporate Private Limited is a legal & regulatory consulting company. We are experts in scientific and regulatory laws that have different consulting divisions like drugs, medical devices, cosmetics,atomic energy, petroleum,legal metrology, telecommunication, environment, trademarks, designs, patents, consumer legislation. We help our clients for export-imports,business setup in India and business consultancy services.
Our team comprises scientists, lawyers and other professionals. We are headquartered in Delhi, India – most of the above laws having their decision making offices herein Delhi enables us to provide the quick and expeditious services to our clientele.
For the medical device industry we offer regulatory registrations, documentations and authorised representation services. We have in-house auditors for IS013485 and for other quality standards as well. Our application for becoming auditors with foreign and Indian notified bodies keeps lies with them and we receive their panels.We have industry-wide connections with medical device distributors to help our clients for distribution of their products in India.
Overview Of Medical Device Registration
Under the aegis of ELT Corporate Pvt ltd, a business, legal & regulatory consulting conglomerate, we offer state-of-the-art Medical Device Regulatory and Consultancy services for the medical fraternity in India. Based at Rohini Sector-3, New Delhi, ELT Corporate under its arm for medical compliances offers an array of consultancy offerings for manufacturers, importers, and authorized agents of medical devices, IVDs, and cosmetics.
ISO 13485
BIS Certification
CDSCO Certification
EPR Services
Comprehensive Regulatory and Compliance Solutions for Medical Devices
ELT Corporate possessing 10+ Years Experience and 500+ Successful CDSCO Registrations in Regulatory and Compliance Services related to Medical Deivces, In-Vitro Devices and Cosmetics. The company’s consulting board is a unique blend of Scientists, Lawyers, Engieneers, Regulatory & Compliance Professionals. We Provide Various Services for Scientific, economic, & commercial laws such as Legal Metrology, BIS, EPR and COSCO Registrations.
With ELT You Enjoy Following Process Ease Benefits:-
- Expert personalized timely approvals.
- 100 percent successful licenses strictly adhering to regulatory norms.
- Ensuring the devices are reaching the end user to use safely without inviting any legal and penal risks.
- Ensuring smooth access to innovative medical devices overseas. Timely and on-demand services.
Our Medical Device Registration Services
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What Is Medical Device Registration?
Medical Device Registration is a regulatory process that includes the submission of information and documents to a government agency and regulatory authority. The process is done to obtain approval or authorization to market and distribute medical devices in a particular jurisdiction.
Medical devices include a wide range of products such as diagnostic equipment, surgical instruments, implantable devices, in vitro diagnostic devices, and more.
The medical device registration is necessary because medical devices on the market need certain safety, efficacy, quality standards, and they are approximately labelled and manufactured. The medical device registration process varies from country to country and is governed by national and international regulations.
Process Of Medical Device Registration
Steps Of Medical Device Registration
We Are Credible Few Names To Whom We Have Served In Medical Device Industry
Frequently Asked Questions
If you are still thinking about CDSCO registration medical device certification or licensing then we are here to find out better solution for you. Our team makes all efforts to solve any kind of query on time.
Yes, After October 1, 2021 every medical device need to registered. Before importing devices in India medical device import license with the CDSCO is mandatory.
The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.
To register Medical devices in India every product category have different time duration such as:-
- Non Notified Class C & D medical devices cab be register currently through the e-portal.
- All A & B Medical devices will typically takes 6 to 9 months for the device approval.
- Product with reference country approval takes less time and quicker review response.
Medical Devices are classified into 4 categories in India accordance:-
It is devices according from low risk Class A to high risk Class D.
- Class A
- Class B
- Class C
- Class D
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