CDSCO Import License Application Process for Medical Devices|MD Form|How to File Import License|NSWS

Подробнее о видео

CDSCO Import License Application Process for Medical Devices|MD Form|How to File Import License|NSWS@ivdmanufacturing7208

Chapter V
Import of Medical Devices
34. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.
(2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule:
Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be informed, in writing, to the Central Licensing Authority.
(3) Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject it to evaluation, test or examination, the authorised agent shall pay a fee for such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.
(4) Any subsequent application for,-
(i) grant of licence for additional manufacturing site for the same medical device by the same authorised agent shall be accompanied with a fee and documents as referred in sub-rule (2);
(ii) licence for additional medical device manufactured at the same manufacturing site shall be made by the same authorised agent accompanied with fee as specified in the Second Schedule and respective documents as specified in the Fourth Schedule.
35. Inspection of overseas manufacturing site.— (1) On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.

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

✨ Subscribe and hit the bell icon to see the latest videos....

Follow Amar on your favorite Social Media Channels:

👉🏻 Facebook:

👉🏻 Instagram:

👉🏻

👉🏻 YouTube:

👉🏻 Whats App:

LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!