Steps to fill the License Application Form on CDSCO Online Portal|MD Form Filling|MDR,2017|IVD|:L-3

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Steps to fill the License Application Form on CDSCO Online Portal|MD Form Filling|MDR,2017|IVD|:L-3@ivdmanufacturing7208

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Online Portal for Medical devices enables applicant to submit online applications for Medical Devices regulatory process to CDSCO. It will also enable upload of supporting documents, respond to queries from CDSCO officials and track their application status. The user account lists out all the applications submitted and licenses/permissions held by them and provides the statistical analysis of the applications for various processes & licenses issued, suspended /cancelled, withdrawn.

MDR-2017 (Medical Device Regulation)

List of Queries -
List of forms under Medical Devices Rules, 2017:
Application for grant of certificate of registration of a notified body (Form MD1)
Certificate of Registration for a notified body under the Medical Devices Rules, 2017 (Form MD2)
Application for grant of license to manufacture for sale or for distribution for Class A or Class B medical device(Form MD3)
Application for grant of loan license to manufacture for sale or distribution of Class A or Class B medical device(Form MD4)
Licence to manufacture for sale or for distribution of Class A or Class B Medical Device(Form MD5)
Loan Licence to manufacture for sale or for distribution of Class A or Class B Medical Device(Form MD6)
Application for grant of license to manufacture for sale or for distribution of Class C or Class D medical devices(Form MD7)
Application for grant of loan license to manufacture for sale orfor distribution of Class C or Class D medical device(Form MD8)
Licence to manufacture for sale or for distribution of Class C or Class D Medical Device(Form MD9)
Loan Licence to manufacture for sale or for distribution of Class C or Class D Medical Device (Form MD10)
Application for license to manufacture medical devicefor purpose of clinical investigations,
test, evaluation, examination, demonstration, or training (Form MD12)
Licence to import MedicalDevice(Form MD15)
Permission to conduct clinical investigation of an
Investigational Medical Device (Form MD23)
Permission to conduct clinical performance evaluation of New In-Vitro Diagnostic MedicalDevice
Medical Device Registration in India
Test License Application
Manufacturing License Application
Classification of Medical Device
ClassA
ClassB
ClassC
ClassD
How to add address
How to edit address
how to add site address
IVD Registration in India
CDSCO Registration in India
How to register Medical Device in India
what is the Registeration process of CDSCO in India
What is the Registeration process of Medical Device in India
Register your Medical Device in CDSCO India
What is Online System for Medical Device CDSCO
What is the benefits of Online System for Medical Device CDSCO
Online System for Medical Device CDSCO kya hota hai ?
Online System for Medical Device CDSCO kya hai ?
Online System for Medical Device CDSCO Guidelines ?
Classification of medical devices
Medical device grouping
Medical Device Registration In India | CDSCO guidelinesREGISTRATION OF CLASS A (NON-STERILE AND NONMEASURING) MEDICAL DEVICES
MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
Application for manufacture for sale or for distribution of Class A 12
[(other than non-sterile and non-measuring)] or Class B medical device
Application for manufacturing Class C or Class D devices
Requirements for grant of manufacturing licence or loan licence
Test licence to manufacture for test, evaluation, clinical investigations,
Application for grant of import licence
The manufacturer of a medical device shall upload the information
specified in sub-rule (2) relating to that medical device for registration on the
"Online System for Medical Devices" established by the Central Drugs
Standard Control Organisation for this purpose.


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