| Scope: |
This ESSENTIAL describes the regulatory requirements of IVD medical devices in India, based on
- The Drugs and Cosmetics Act
- Medical Devices Rules, 2017
- CDSCO Guidance Documents
- BIS Certification Rules (for special electric/electronic devices included in medical devices).
All IVD products are regulated under the Medical Device Rules 2017 (MDR-2017).
Health products in India are classified into four risk classes.
Not in scope of this CRF (although also regulated by the Medical Devices Rules, 2017)
- Non-IVD Medical Devices (see: ESSENTIAL IND Medical Devices)
For the certification of electronic products integrated into medical devices, see the Regulatory ESSENTIAL ESS IND Electrical Safety - CRS Electronic and IT products
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| Legislation in force: |
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)
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| Comment on the comparability to EU legislation: |
IVD Medical Device certificates from national authorities of the European Union are accepted.... |