In 2018, four more categories of devices; Nebulizer, Blood pressure monitoring devices, Digital Thermometer and Glucometer were added in the notified devices list, which would be effective from the 1st of January 2020.

All Implantable Medical Devices along with CT Scan equipment, MRI equipment, Defibrillators, Dialysis machine, PET equipment, X-Ray Machine and Bone Marrow cell separators were included in the notified regulated devices list. Implementation of this inclusion will be effective from 2020. In total 379 Medical devices and 247 IVD Devices of notified category are already listed under provision of Rule 4 of MDR.

Import, manufacture or selling a medical device in India that comes under the notified list, would require regulatory compliance as per MDR 2017. That has some mandatory requirements such as Quality Management System (QMS) implemented, Risk Management (as per ISO 14791), Device Master File (DMR). A few requirements are product specific i.e; Electrical Safety testing (ISO 60610), Medical Device Usability (ISO 62366), Biocompatibility testing (ISO 10993).

With all these things ready, one can apply for the manufacturing license to the Central Licensing authority (Class C & D) or State Licensing authority (Class A & B).

The MDR 2017 comprises 12 Chapters, 97 Rules, 8 Schedules and 40 Forms.

Chapter 1: Short Title & Commencement, Application & definitions
Chapter 2: Regulation of Medical Device
Chapter 3: Authorities, Officers and Bodies
Chapter 4: Manufacture of Medical Devices for sale or for distribution
Chapter 5: Import of Medical Devices
Chapter 6: Labelling of Medical Devices
Chapter 7: Clinical Investigation of Medical Devices & Clinical Performance Evaluation of New In Vitro Diagnostic Medical Device
Chapter 8: Import of Manufacture Medical Device which does not have Predicate Devices
Chapter 9: Duties of Medical Device Officer, Medical Device Testing Officer & Notified Body
Chapter 10: Registration of Laboratory for carrying out test or Evaluation
Chapter 11: Sale of Medical Device
Chapter 12: Miscellaneous

Schedules

First Schedule: Parameters for classification of medical devices and in vitro diagnostic medical devices
Second Schedule: Fee payable for licence, permission and registration certificate
Third Schedule: Documents required for registration of Notified Body, its duties and functions
Fourth Schedule: Documents required for grant of licence to manufacture for sale or for distribution or import
Fifth Schedule: Quality Management System for medical devices and in vitro diagnostic medical devices
Sixth Schedule: Post Approval Change
Seventh Schedule: Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation
Eight Schedule: Exemptions

Medical Device Regulation - Indian Perspective

Contact supplier

Stay in the loop!