India regulates every medical device under the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation (CDSCO). For O&P, foot health and rehabilitation companies, one of the most important recent developments is CDSCO’s list of Class A non-sterile, non-measuring devices, published in late 2025.
What the list does
Devices on the list are exempt from several licensing chapters of the Medical Devices Rules, provided the manufacturer or importer registers them under the rules’ registration chapter. For eligible products this replaces a licence application with a simpler registration, which can save months.
Which O&P and rehabilitation products are included
The published list includes items such as:
- Ankle-foot orthoses
- Cervicothoracic and cervicothoracolumbosacral spine orthoses
- Back supports and braces
- Ankle sleeves and braces
- Cable-controlled external hand prostheses
- Anti-tremor orthotic gloves
- Cerebral palsy walkers
The list is long and specific. Each product needs to be checked against its exact entry, and a device that is sterile or has a measuring function falls outside it.
What still needs a licence
Devices not covered by the exemption follow the licensing route: Class A and B manufacturing licences are granted by state licensing authorities, while Class C and D are licensed centrally by CDSCO. Imported devices need an import licence from CDSCO, held by an Indian Authorised Agent for foreign manufacturers.
Non-medical products
Products that are not medical devices, such as some general footwear, can fall under Bureau of Indian Standards (BIS) certification instead. Classification decides which regime applies, so it is worth settling before you price, label or ship.
Practical steps
- Map every product in your range against the CDSCO classification and Class A lists
- Separate registration candidates from those that still need licences
- Appoint an Indian Authorised Agent if you manufacture abroad
- Prepare device and plant master files where licences are needed
- Plan distribution and clinician education alongside the paperwork
How Deliberate can help
We classify products, handle CDSCO registrations, licences and Authorised Agent arrangements, and support launch through our Bharat CPO network of prosthetists, orthotists and distributors. See our India services or schedule a call.
This article is general guidance, not legal advice. Confirm the current CDSCO lists and notifications before you rely on an exemption.