Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
THE DRUGS AND COSMETICS ACT, 1940 (abb. The Act)
“drug” includes -
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as maybe specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board
Medical Devices Rules, 2017 (amendments included), abb. MDR-2017
Content:
CHAPTER I - Preliminary (Definitions etc.)
CHAPTER II - Regulation of Medical Device
CHAPTER III - Authorities, Offices and Bodies
CHAPTER III B - Registration of Class A (non-sterile and non-measuring) Medical Devices
CHAPTER IV - Manufacture of Medical Devices for Sale or for Distribution
CHAPTER V - Import of Medical Devices
CHAPTER VI - Labelling of Medical Devices
CHAPTER VII - Clinical Investigation of Medical Device and Clinical Performance Evaluation of new In Vitro Diagnostic Medical Device
CHAPTER VIII - Import or Manufacture Medical Device which does not have Predicate Device
CHAPTER IX - Duties of Medical Device Officer, Medical Device Testing Officer and Notified Body
CHAPTER X - Registration of Laboratory for carrying out Test or Evaluation
CHAPTER XI - Sale of Medical Devices
CHAPTER XII - Miscellaneous
1. SCHEDULE - Parameters for Classification of Medical Devices and In Vitro Diagnostic Medical Devices
Part 1 - Parameters for classification of medical devices other than in vitro diagnostic medical devices
Part 2 - Parameters for classification for in vitro diagnostic medical devices
2. SCHEDULE - Fee Payable for License, Permission and Registration Certificate
3. SCHEDULE - Documents required for Registration of Notified Body, its Duties and Functions
4. SCHEDULE - Documents Required for Grant of License to Manufacture for Sale or for Distribution or Import
5. SCHEDULE - Quality Management System for Medical Devices and In Vitro Diagnostic Medical Devices
6. SCHEDULE - Post Approval Change
7. SCHEDULE - Requirements for Permission to Import or Manufacture Investigational Medical Device for Conducting Clinical Investigation
8. SCHEDULE - Exemptions
APPENDIX - Forms (Form MD-1 - Form MD-43)
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
IVD Medical Device certificates from national authorities of the European Union are accepted....