MD 15 license for medical device imports in India explained
MD-15 is India's medical device import licence. MD-14 is the application. Compare manufacturing and loan-licence forms, with the Class A exemption caveat.
MD 15 license for medical device imports in India
An MD 15 license is the Form MD-15 commercial import licence issued by India's Central Licensing Authority, where an import licence is required. You apply in Form MD-14, as CDSCO's medical-device guidance states.
MD-15 won't cover manufacture. Manufacturing and loan licences use other form pairs under the Medical Devices Rules, 2017.
MD-14 and MD-15 versus manufacturing forms
Pick the activity first: commercial import, manufacture or a loan licence. For manufacture, class decides the form pair and who grants it. Rules 20, 21, 25 and 34 to 36 of the 2017 Rules set those routes out.
| Route | Application | Granted licence | Licensing authority |
|---|---|---|---|
| Class A and B manufacture, subject to exemptions | MD-3 | MD-5 | State Licensing Authority |
| Class A and B loan licence, subject to exemptions | MD-4 | MD-6 | State Licensing Authority |
| Class C and D manufacture | MD-7 | MD-9 | Central Licensing Authority |
| Class C and D loan licence | MD-8 | MD-10 | Central Licensing Authority |
| Commercial import, where a licence is required | MD-14 | MD-15 | Central Licensing Authority |
Class C and D still split by route. CDSCO lists MD-7 and MD-9 for manufacturing, and MD-8 and MD-10 for a loan licence. MD-9 is not another name for MD-10.
For Class A, check the exemption before choosing a form. CDSCO lists G.S.R. 777(E) of 14 October 2022, an exemption notification for Class A devices that are both non-sterile and non-measuring. That notice is not a Class B waiver. Check it, and any registration requirement that still applies, before you treat MD-3 or MD-5 as mandatory. But an exempt device is not an unregulated device.
What the MD 15 license number means
MD-15 names the form. The digits 15 do not mark risk class. The Rules assign different form identifiers to applications, manufacturing licences, loan licences and import licences, so MD-3, MD-5, MD-7, MD-9, MD-14 and MD-15 name the form and not a company's own licence number.
On a supplier's document, read the form code, then whether it is an application or a granted licence, and which authority issued it. If it says MD-14, someone has applied, and that is not proof the Central Licensing Authority has granted an MD 15 license. Domestic manufacture needs the manufacturing route, not an import form.
Before you choose a form
Name the activity and the class, then match the application to the licence you need. For a commercial import, CDSCO says the applicant files MD-14 on the sugam online portal for grant of an import licence in MD-15. Filing that application does not tell you whether a non-sterile, non-measuring Class A device still needs a licence.
The form number will not tell you the current fees, the supporting documents or the licence-retention rules. Use the Rules and later amendments for those checks. This comparison is the 2017 form map, not a filing checklist.
RegAffairs AI's answer on import and manufacturing licences cites the original 2017 Rules, not a consolidated text of the law as it stands now.