State approvals / Delhi / Drugs Control Department
Manufacturing License for Class A & B Medical Devices
Manufacturers of Class A (excluding non-sterile and non-measuring devices) and Class B medical devices are required to obtain an MD-5 certificate for manufacturing or distribution in India. The process ensures that all medical devices meet high standards of safety, efficacy, and quality before reaching the market. MD-03 is the application form which is submitted to the state licensing authority and MD-05 is granted as the registration certificate for the manufacturing purpose.
DepartmentDrugs Control Department
TypeNew
StagePre-Establishment
Time limit20 days
FeeNo fee
Applied—
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Constitution Details | — | Required |
| 2 | Site or Plant Master File | — | Required |
| 3 | Device Master File | — | Required |
| 4 | Test License | — | Required |
| 5 | Compliance Undertaking • Label, Product broachers & IFU | Additional Documents | If applicable |
| 6 | Performance Evaluation Report (for In-Vitro Diagnostic Devices) | Additional Documents | If applicable |
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