Chapter -1- Indian Medical Device Rules , 2017 |Indian CDSCO MDR 2017| IVDs| L-2 скачать в хорошем качестве

Chapter -1- Indian Medical Device Rules , 2017 |Indian CDSCO MDR 2017| IVDs| L-2

Chapter 1 Preliminary Indian Medical Device Rules , 2017 |Indian CDSCO MDR 2017| IVDs| L-2‪@ivdmanufacturing7208‬ MEDICAL DEVICES RULES, 2017 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) Chapter I Preliminary 1. Short title and commencement.—(1) These rules may be called the Medical Devices Rules, 2017. (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018. 2. Application.— These rules shall be applicable in respect of,- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub- clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940); 3. Definitions.— In these rules, unless the context otherwise requires,- (a) “academic clinical study” means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population; (b) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940); 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:   / adsivdmanufacturing   👉🏻 Instagram:   / adsivdmanufacturing   👉🏻   / amar-dinesh-singh-aba258a4   👉🏻 YouTube:    / @ivdmanufacturing7208   👉🏻 Whats App:https://whatsapp.com/channel/0029Va95... LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!