India · Central Drugs Standard Control Organisation · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
4 requirements
Application fee
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Class A devices that are not sterile and have no measuring function are not licensed. The maker registers them by uploading device details and self-certifications on the online system. No fee is charged for the registration number. Class A medical devices that are non-sterile and non-measuring.
1. Upload device details and self-certifications; 2. Registration number.
Outcome: A registration number generated on the online system.
Legal basis: Medical Devices Rules, 2017, Chapter IIIB (rules 19G onward), inserted by G.S.R. 777(E) of 14 Oct 2022 and amended by G.S.R. 744(E) of 14 Aug 2026
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in India: Import licence for medical devices and IVDs, Manufacturing licence for Class A and B devices, Manufacturing licence for Class C and D devices, Permission for a medical device without a predicate, Permission for a new in vitro diagnostic device. See all routes on the India page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.