India · Central Drugs Standard Control Organisation · Medical devices
Review target
-
Not published
Legal time limit
274 days
regulation
Steps
5
9 requirements
Application fee
$6,000
Second Schedule rates in force since 2017
All classes of medical devices and in vitro diagnostics made abroad need an import licence from the Central Licensing Authority. An authorised agent in India applies on the online portal. The rules set a nine month limit for the decision. Devices with a free sale certificate from Australia, Canada, Japan, the European Union, the United Kingdom or the United States are licensed without a clinical investigation. Any imported medical device or IVD in Class A, B, C or D, except Class A non-sterile and non-measuring devices, which are registered instead.
The inspection of the overseas manufacturing site is $6,000 for Second Schedule rates in force since 2017.
1. Application in Form MD-14 on the online portal; 2. Possible inspection of the overseas site; 3. Review of documents and decision (274 days); 4. Import licence in Form MD-15; 5. Post market duties.
Yes. It relies on approvals from Australia, Canada, European Union, United Kingdom, Japan, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: Import licence in Form MD-15, valid without end date if the retention fee is paid every five years.
Legal basis: Drugs and Cosmetics Act, 1940; Medical Devices Rules, 2017, Chapter V (rules 34 to 39), Second and Fourth Schedules
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 274 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
| Legal time limitregulation. Nine months in the rules. This is the time limit written in the rules. It is an official target, not a measured review time. | 274 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Inspection of the overseas manufacturing siteInspection · Second Schedule rates in force since 2017 | $6,000 |
| Import licence, Class C or D IVD, per overseas siteEstablishment · Second Schedule rates in force since 2017 | $3,000 |
| Import licence, Class C or D device (non IVD), per overseas siteEstablishment · Second Schedule rates in force since 2017 | $3,000 |
| Import licence, Class B device (non IVD), per overseas siteEstablishment · Second Schedule rates in force since 2017 | $2,000 |
| Import licence, Class C or D device (non IVD), per distinct deviceProduct · Second Schedule rates in force since 2017 | $1,500 |
| Import licence, Class A device (non IVD), per overseas siteEstablishment · Second Schedule rates in force since 2017 | $1,000 |
| Import licence, Class B device (non IVD), per distinct deviceProduct · Second Schedule rates in force since 2017 | $1,000 |
| Import licence, Class A or B IVD, per overseas siteEstablishment · Second Schedule rates in force since 2017 | $1,000 |
| Import licence, Class C or D IVD, per distinct IVDProduct · Second Schedule rates in force since 2017 | $500 |
| Import licence, Class A device (non IVD), per distinct deviceProduct · Second Schedule rates in force since 2017 | $50 |
| Import licence, Class A or B IVD, per distinct IVDProduct · Second Schedule rates in force since 2017 | $10 |
Other routes in India: Manufacturing licence for Class A and B devices, 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 (36 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.