Notified Device Categories — Schedule I & II
Scope of MDR 2017
A critical feature of India's regulatory framework is that MDR 2017 applies only to device categories that have been formally notified in Schedule I (medical devices) or Schedule II (IVDs) through gazette notifications. Devices not yet notified are not subject to mandatory CDSCO licensing.
Schedule I — Medical Devices (selected categories)
The following categories have been notified and are subject to MDR 2017 (this is not exhaustive — always verify the current gazette):
- Cardiac stents and coronary stents
- Drug-eluting stents
- Orthopaedic implants (hip, knee, spine, trauma)
- Intraocular lenses (IOLs)
- IV cannulae, syringes, hypodermic needles
- Blood pressure monitors, pulse oximeters
- CT scanners, MRI equipment, X-ray equipment
- Ultrasound equipment
- Infusion pumps, syringe pumps
- Ventilators, anaesthesia machines
- Dialysis equipment
- Hearing aids
- Urinary catheters
- Surgical drapes and gowns
- Condoms
- Bone cement
- Vascular grafts
Schedule II — IVDs (selected categories)
- HIV test kits
- Hepatitis B and C test kits
- Blood glucose monitoring systems
- Haematology analysers
- Pregnancy test kits
- COVID-19 antigen and RT-PCR test kits
- Dengue, malaria, typhoid rapid tests
- Blood grouping reagents
- Cholesterol and lipid test kits
Monitoring for updates
CDSCO periodically expands Schedules I and II through gazette notifications published in the Official Gazette of India. Manufacturers should monitor:
If your device is not currently notified, it is still good practice to maintain technical documentation and quality systems in preparation for future notification.
This is a representative sample. The complete list of notified Schedule I devices is updated periodically via Official Gazette of India notifications. Verify your specific device category at: CDSCO website (Medical Devices section) or search the India Gazette archive.'
For Schedule II: 'This is a representative sample. The complete list of notified Schedule II IVD categories is maintained in the Official Gazette of India. Devices not listed may still require CDSCO approval if they pose similar risks; consult CDSCO for device classification confirmation.