Chapter -5 | Part-3|Grant of Import license MD 15 |Import License|L-12|CDSCO MDR 2017 regulation

Chapter -5 | Part-3|Grant of Import license MD 15 |Import License|L-12|CDSCO MDR 2017 regulation‪@ivdmanufacturing7208‬

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

36. Grant of import licence.— (1) After examination of documents furnished
with the application under sub-rule
(1) of rule 34 and on the basis of the inspection report, if inspection has been
carried out, the Central Licensing Authority may, on being satisfied, grant
licence in Form MD-15 or, may reject such application for which reasons shall
be recorded in writing, within a period of nine months from the date of
application.
(2) In the event of rejection, the applicant may appeal to the Central
Government within a period of forty five days and that Government, may, after
such enquiry into the matter, as considered necessary, pass orders in relation
thereto within a period of ninety days from the date of appeal.
(3) Where, a free sale certificate has already been issued in respect of any
medical device by the national regulatory authority or other competent authority
of any of the countries namely, Australia, Canada, Japan, European Union
Countries, or the United States of America, a licence shall be granted under sub-
rule (1) to the applicant without carrying out clinical investigation.
(4) Where a medical device is imported from countries other than those
referred to in sub-rule (3), the licence in case of Class C and Class D medical
devices may be granted after its safety and effectiveness has been established
through clinical investigation in India as specified under provisions of Chapter
VII of these rules.
(5) Where a medical device, is imported from countries other than those
referred to in sub-rule (3), the licence in case of Class A or Class B medical
devices may be granted after its safety and performance has been established
through published safety and performance data or through clinical investigation
in the country of origin and a free sale certificate from the country of origin is
furnished.
(6) In case of investigational medical device or new in vitro diagnostic
medical device, the applicant shall obtain prior permission in Form MD-27 or in
Form MD-29 from the Central Licensing Authority and no licence to import any
class of such medical device shall be granted without such permission.

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
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IVD Registration in India
CDSCO Registration in India
How to register Medical Device in India
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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 ?
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Classification of medical devices

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