Medical devices in India are primarily regulated by CDSCO (Central Drugs Standard Control Organisation) under the Medical Devices Rules 2017. However, BIS standards and certification also intersect with medical devices in important ways.
CDSCO has primary regulatory authority over medical devices in India. The Medical Devices Rules 2017 require Class A, B, C, and D medical devices to be registered with CDSCO. This is a separate and additional requirement from any BIS certification.
CDSCO technical requirements for medical devices often reference BIS/ISO/IEC standards. For electrical medical devices, IS/IEC 60601-1 (General requirements for safety and essential performance of medical electrical equipment) is typically referenced. This is distinct from IS/IEC 62368-1:2023 (which is for IT and AV equipment, not medical equipment).
Products used in healthcare settings but not classified as medical devices (refrigerators in hospitals, air purifiers in clinics, water dispensers, electric kettles in hospital pantries) are subject to standard IS 302 Part 1 certification requirements — not medical device regulations.
Some products sit at the IS 302 vs. medical device boundary — heating pads, TENS devices, massage devices. Products without medical claims → IS 302 Part 1. Products with medical claims → CDSCO Medical Devices Rules. Some products may need both.
If your product has any medical or therapeutic claim, consult a regulatory specialist to determine: (1) is it classified as a medical device under CDSCO? (2) does it also require BIS certification? For most electrical medical devices: CDSCO registration is primary; BIS certification may also be required for specific components.