India · Central Drugs Standard Control Organisation · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
90 days
regulation
Steps
4
2 requirements
Application fee
₹25,000
Second Schedule rates in force since 2017
A new IVD needs permission from the Central Licensing Authority, usually after a clinical performance evaluation. The authority decides within 90 days, extendable by 30 days. Class A IVDs may not need clinical performance data. New IVDs before an import or manufacturing licence is granted.
The permission to import or manufacture a new ivd is ₹25,000 for Second Schedule rates in force since 2017.
1. Clinical performance evaluation; 2. Application in Form MD-28; 3. Review and decision (90 days); 4. Permission in Form MD-29.
Outcome: Permission in Form MD-29, followed by an import or manufacturing licence.
Legal basis: Medical Devices Rules, 2017, rules 59 and 64
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 90 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. May be extended by up to 30 days. This is the time limit written in the rules. It is an official target, not a measured review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Permission to import or manufacture a new IVDApplication · Second Schedule rates in force since 2017 | ₹25,000 |
| Permission to conduct a clinical performance evaluationApplication · Second Schedule rates in force since 2017 | ₹25,000 |
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, Registration of Class A non-sterile and non-measuring devices. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.