Chapter -3 | Part-2 | Notified Body -Authorities, Officers and Bodies I CDSCO MDR 2017 | IVDs| L-5

Подробнее о видео

Chapter -3 | Part-1 | Notified Body -Authorities, Officers and Bodies I CDSCO MDR 2017 | IVDs| L-5@ivdmanufacturing7208

MEDICAL DEVICES RULES, 2017
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)

Licensing Authorities.— (1) The Central Licensing Authority shall be the
competent authority for enforcement of these rules in matters relating to,-
(1) import of all Classes of medical devices;
(ii) manufacture of Class C and Class D medical devices;
(iii) clinical investigation and approval of investigational medical devices;
iv) clinical performance evaluation and approval of new in vitro diagnostic
medical devices and;
(v) co-ordination with the State Licensing Authorities.
(2) The State Drugs Controller, by whatever name called, shall be the State
Licensing Authority and shall be the competent authority for enforcement of
these rules in matters relating to,-
(i) manufacture for sale or distribution of Class A or Class B medical devices;

Delegation of powers of Licensing Authorities
Controlling Officer
National Accreditation Body


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 !!!!!!