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

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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)

Chapter II
Regulation of Medical Device
4. Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:—
(i) (ii) (iii) (iv)
low risk - Class A;
low moderate risk- Class B;
moderate high risk- Class C;
high risk- Class D.
In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:—
(2)
(i) (ii) (iii) (iv)
low risk - Class A;
low moderate risk- Class B;
moderate high risk- Class C;
high risk- Class D.
(3)
in rule 2, based on the intended use of the device and other parameters specified in the First Schedule.
The Central Licencing Authority shall, classify medical devices referred to
(4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation:
Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.
5. Medical device grouping.— Any person who intends to apply for grant of licence in respect of medical devices for,-
(i) import;
(ii) manufacture for sale or for distribution; and
(iii) sale, stock, exhibit or offer for sale,
may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices.
6. Essential principles for manufacturing medical device

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

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