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:
info
If your device is not currently notified, it is still good practice to maintain technical documentation and quality systems in preparation for future notification.