Medical Devices/Diagnostic Kits

Medical Devices and In-vitro Diagnostics (IVD)are regulated in India through the Medical Device Rules, 2017. The authority which regulates medical device and In-Vitro Diagnostics (IVD) in India is the Central Drugs Standard Control Organisation (CDSCO), which is headed by the Drug Controller General of India (DCGI). The approval with respect to medical device is granted by the Central Licensing Authority (CDSCO) and the State Licensing Authority (SLA), depending upon the class of the medical device.
Medical Devices are classified into 4 classes based on the extent of risk associated with these devices.

Device Class              Risk
      A                         Low Risk
      B                         Low Moderate Risk
      C                         Moderate – High Risk
      D                         High Risk

We provide the manufacturers and importers of medical devices & IVDs, necessary guidance and strategies in obtaining various licenses for their products and business –

To Manufacturers –

The Central Licensing Authority (CLA) is the agency which grants the license for manufacturing of Class C and D medical devices& IVDs, whereas, the State Licensing Authority (SLA) grants the license for manufacturing of Class A and B medical devices & IVDs.Test license for production of all classes of medical devices is also granted by the Central Licensing Authority (CLA).

We help the manufacturers in getting the following necessary approvals from the authorities –
1. Form MD-5 and Form MD-6
Permission to Manufacture or Permission for Loan License to Manufacture Class A and B Medical Device in India
2. Form MD-9 and Form MD-10
Permission to Manufacture or Permission for Loan License to Manufacture Class C and D Medical Device in India
3. Form MD-12 and Form MD-13
Permission for Test License to Manufacture Medical Device in India
4. Form MD-27
Permission to Manufacture New Medical Device

To Importers –

As per the MDR, 2017, a foreign company can market its product only through an Indian Authorized Representative (IAR), for which the IAR shall have an active wholesale license as provided in Form 20B and 21B. We, at CoreLEX have the necessary wholesale license to act as your IAR, which allows us to act on your behalf in seeking permission to import medical devices& IVDs in India.

We provide the importers technical guidance and infrastructure to get the following approvals-

1. Registration of Indian Authorized Representative (IAR)
   2. Form MD-14 and Form MD-15
   Permission for Import License
   3. Form MD-16 and Form MD-17
   Permission for Test License to Import Medical Device
   4. Form MD-27
   Permission to Import New Medical Device

We also provide technical guidance and support in getting the approval for Form MD-22 and Form MD-23, Permission to conduct Clinical Investigation for Investigational Medical Device.