India

India Medical Device Classification

The Indian classification system is based on the MDR 2017 Guidance and are dependent on the intended use, level of risk, delivery method, and the degree of invasiveness in the human body. The Indian regulatory system is currently in a transition period and only a specified list of product types requires Import Licenses. All other medical devices can be submitted Voluntarily during the current grace period. After this voluntary period, all class A and B non-Regulatory medical devices will have 12 months (i.e., by October 1, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1, 2023) to meet the same requirement. The Indian Central Drugs Standards Control Organization (CDSCO) defines a list of notified medical devices (see below).

List of Notified Medical Devices:

· Disposable Hypodermic Syringes

· Disposable Hypodermic Needles

· Disposable Perfusion Sets

· IVD Devices for HIV, HBsAg, HCV

· Cardiac Stents

· Drug Eluting Stents

· Catheters

· Intra Ocular Lenses

· I.V. Cannulae

· Bone Cements

· Heart Valves

· Scalp Vein Set

· Orthopaedic Implants

· Internal Prosthetic Replacements

· Blood Grouping Sera

· Ligatures, Sutures and Staplers

· Intra Uterine Devices (CuT)

· Condoms

· Tubal Rings

· Surgical Dressings

· Umbilical tapes

· Blood/Blood Component Bags

· Ablation Devices

· Organ Preservation Solution

· Blood Pressure Monitors (January 1, 2021)

· Digital Thermometers (January 1, 2021)

· Glucometers (January 1, 2021)

· Nebulizers (January 1, 2021)

· X-Ray Machines (April 1, 2021)

· CT Scan Equipment (April 1, 2021)

· MRI Equipment (April 1, 2021)

· PET Equipment (April 1, 2021)

· Defibrillators (April 1, 2021)

· Dialysis Machines (April 1, 2021)

· Bone Marrow Cell Separators (April 1, 2021)

· All Implantable Medical Devices (April 1, 2021)

· Ultrasound Devices (November 1, 2021)

· Disinfectants and insecticides specified in Medical Device Rules, 2017

Products are classified into one of the following, from lowest to highest risk:

Class A
Class B
Class C
Class D

India’s classification rules differ from the GHTF or ASEAN MDD as they’ve outlined in each product types medical devices are first designated as one of the following 24 categories:

Anesthesiology
Pain Management
Cardiovascular
Dental
Ear, Nose, and Throat (ENT)
Gastroenterological
Urological
General Hospital
Operation Theater (OT)
Respiratory
Neurological
Personal Use
Obstetrical and Gynecological (OG)
Ophthalmic
Rehabilitation
Physical Support
Interventional and Radiology
Rheumatology
Dermatology and Plastic Surgery
Pediatric and Neonatology Medical
Oncology
Radiotherapy
Nephrology and Renal Care
Software

These categories are then broken down further into specific product categories depending on the products intended use and assigned a classification. For the complete list of product types and their classification, please click here.