The Central Drugs Standard Control Organisation (CDSCO) of India has issued a notice on October 25, 2023, updating several in-vitro diagnostic (IVD) classifications.
These updates mean that all medical devices, regardless of class, must either be registered in India through the ePortal or receive an MD-15 import license before importing.
The updated IVD classification is as follows.
- Annex A for IVD Analyzer: A total of 72 medical devices are included.
- Annex B for IVD equipment: A total of 28 medical devices are included, all of which are classified as Class A.
- IVD Software Annex C: There are no changes to a total of eight, but all software that drives or affects equipment use automatically falls into the same class.
- IVD Sample Container Annex D : A total of 5 are added to this list.
- IVD (COVID-19, DNA, mRNA) Annex E: A total of 5 are added to this list.
IVD is classified into five categories based on risk level, use, etc. as follows.
- Class A (non-measured/sterile)
- Class A (Measuring/Sterile)
- Class B
- Class C
- Class D
We expect that these changes may affect the registration process for some medical device manufacturers, license holders and distributors.
Please refer to the file below for details.
If you have any questions about medical device in India,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net