Non-Notified Medical Devices Registration/ Approval in India
CliniExperts acts as an authorized representative to help you in getting the permission to import non-notified medical devices in India. Register your Non-notified Medical Devices in India with CliniExperts' professional assistance.
Registration Number for Non-Notified Medical Devices – Overview
Who Can Apply?
Any Importer and local manufacturer can apply for the Registration of non-notified Medical Devices
How To Apply?
The Applicant must follow the following process:
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Follow the URL https://cdscomdonline.gov.in/NewMedDev/Homepage
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Applicant has to click on the registration link from the portal.
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Applicant has to register with a valid Email-id and Mobile No.
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The applicants has to upload the following documents for registering on the portal:-
• Id Proof Details • Undertaking • Corporate Address Proof Details (Certificate of Incorporation) • Copy of Manufacturing License and the Wholesale Licenses (If not then upload the justification for the same) -
The applicant has to verify the registration through the OTP (4 digits) received on the mobile, after verification the applicant can login and proceed further.
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Applicants need to upload the relevant documents as per the Registration Number checklist.
Validity
The Registration for class A and class B medical devices would be valid till Sep 2022, and class C and class D medical devices would be valid till Sep 2023.
Fee Involved
Government fee is not applicable to obtain voluntary registration number.Important Documents
- Free Sale Certificate from country of origin if the product will be imported and ISO 13485 certificate.
- Free Sale Certificate from country of origin in case of Import only.
- ISO 13485 certificate in case of import and manufacturing both.
- Details of the medical device include intended use, construction material, accessories/component dimension, sterilization, and shelf life.
Timeline to get from CDSCO
Essential Tips
The applicant looking to obtain a voluntary registration number must ensure these essentials are followed:
- The applicant must have a Free Sale Certificate in case of import and an ISO 13485 Certificate.
- If the regulatory status of the medical device has not been justified, clarity should be obtained from the regulatory authority. This needs to be done before the VRN application.
- The medical device needs to be classified in the class if it is not specified by the regulatory body.
Expert Advise
After the expiry of voluntary registration number validity, the rules of import or manufacturing license might apply.
The importer or the manufacturer of the medical device must comply with the safety and quality requirements of the product.
Related Services
Frequently Asked Questions
Does the importer or manufacturer need to have an ISO 13485 Certificate?
Yes, an ISO certificate is compulsory.
Who is eligible to apply for a Voluntary Registration Number?
Both importer and manufacturer can apply for the voluntary registration number.
Where can an individual check the risk class of a non-notified device?
An individual can check the CDSCO Classification List to check the risk class of a non-notified device.