The Origin of the Indian Medical Device Rules, 2017|Indian CDSCO MDR 2017| IVDs| Medical Device

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The Origin of the Indian Medical Device Rules, 2017|Indian CDSCO MDR 2017| IVDs| Medical Device@ivdmanufacturing7208

MEDICAL DEVICES RULES, 2017
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 31st January, 2017
G.S.R. 78(E).—WHEREAS the draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and Sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government, after consultation with the Drugs Technical Advisory Board, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Gazette containing the said notification were made available to the public;
AND WHEREAS, copies of the Gazette containing the said notification were made available to the public on the 17th October, 2016;
AND WHEREAS, all objections and suggestions received in response to the said draft notification have been duly considered by the Central Government;
NOW, THEREFORE, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules, namely,-



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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