India · State Licensing Authorities (State Drugs Controllers) · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
4 requirements
Application fee
₹5,000
Second Schedule rates in force since 2017
Makers of Class A and B devices and IVDs in India apply to the State Licensing Authority on the online portal. A registered notified body audits the site against the quality management system rules. For Class B, the audit comes before the licence. For Class A, the licence comes first and the audit follows within 120 days. Domestic manufacture of Class A (other than non-sterile and non-measuring) and Class B devices and IVDs.
The manufacturing licence, class a or b, per site is ₹5,000 for Second Schedule rates in force since 2017.
1. Application in Form MD-3 on the online portal; 2. Notified body audit before licence (Class B) (90 days); 3. Notified body report (Class B) (30 days); 4. Licence decision (Class B) (20 days); 5. Licence decision (Class A) (45 days); 6. Notified body audit after licence (Class A) (120 days).
Outcome: Manufacturing licence in Form MD-5, valid without end date if the retention fee is paid every five years.
Legal basis: Medical Devices Rules, 2017, rules 13 and 20 to 30, Fifth Schedule
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).
About 165 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionregulation. Class A licence decision. For Class B, the audit (90 days), report (30 days) and decision (20 days) run in sequence. This is the time limit written in the rules. It is an official target, not a measured review time. | 45 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Manufacturing licence, Class A or B, per siteEstablishment · Second Schedule rates in force since 2017 | ₹5,000 |
| Manufacturing licence, Class A or B, per distinct deviceProduct · Second Schedule rates in force since 2017 | ₹500 |
Other routes in India: Import licence for medical devices and IVDs, Manufacturing licence for Class C and D devices, Registration of Class A non-sterile and non-measuring 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.