Chapter -5 | Part-4|Validity of Import license MD 15 |Import License|L-13|CDSCO MDR 2017 regulation

Chapter -5 | Part-4|Validity of Import license MD 15 |Import License|L-13|CDSCO MDR 2017 regulation

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)

Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall
remain valid in perpetuity, unless, it has been cancelled or surrendered,
provided the authorised agent deposits the licence retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas
manufacturing site and for each licenced medical device after completion of
every five years from the date of its issue:
Provided that the Central Licensing Authority may permit to deposit the
licence retention fee after due date but before expiry of ninety days with a late
fee calculated at the rate of two per cent. per mensem:
Provided further that if the licencee fails to deposit the licence retention
fee within the above stipulated period, the licence shall be deemed to have been
cancelled.

MDR-2017 (Medical Device Regulation)

List of Queries -
List of forms under Medical Devices Rules, 2017:
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

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