In September, CDSCO has proposed new risk-based classification lists for previously non-notified general and IVD medical devices. This is to ensure the regulatory pathways and requirements are well-defined for each of these now-notified medical devices. CDSCO classifies these medical devices as per risk-based approach, in accordance to MDR 2017 Chapter 11. The newly notified and previously notified medical devices are all divided into 24 categories.

As a background, India’s Health Ministry had notified a new definition of medical devices with an intent to bring all medical devices under the purview of MDR 2017, back in February 2020. Prior to such notification, only 37 categories of medical devices that it had notified were regulated by MDR. The new definition took effect from April 1, 2020, which means that MDR started applying to all medical devices from April 1, 2020. 

The Drugs Controller General of India (DCGI) has now done its preliminary assessment and published a draft of medical device risk classification covering all medical devices for public comments. Medical devices have been split into 24 categories 


Pain Management



Ear, Nose, Throat (ENT)



General Hospital

Operation Theatre



Personnel Use

Obstetrical and Gynecological



Physical support

Interventional and Radiology


Dermatology and Plastic Surgery

Pediatric and Neonatology Medical



Nephrology and Renal care


IVD devices have been split into 3 categories:

  •      1. IVD Analyzer
  •      2. IVD Instrument
  •      3. IVD Software

There are some surprises in the new risk classification lists. Sanitary pads, menstrual cups, tampons, fertility, conception software, birthing bath and new-born infant bed are sought to be regulated as medical devices. 

It is hoped that all manufacturers marketing or in the plans of marketing their medical devices in India take good note of this risk classification, as they can be different from other jurisdictions.



Classification of non-notified Medical Devices-reg