Regulatory ยท CDSCO Consultant
Medical Device Import License
Form MD-15 import licensing for Class A to Class D medical devices.
What is Medical Device Import License?
Medical devices in India are classified A (low risk) through D (high risk) under the Medical Device Rules, 2017, and Class C/D devices in particular require an import licence (Form MD-15) before they can be brought into the country, alongside registration of Class A/B devices.
Risk-based device classification exists so regulatory scrutiny scales with actual patient risk โ a basic diagnostic consumable and an implantable device pose very different consequences if something goes wrong, and the Medical Device Rules calibrate documentation, testing, and review depth accordingly rather than applying one uniform process to every device.
Classification is the single most consequential decision in this process: it determines whether your device needs full import licensing (Class C/D, via Form MD-15) or the lighter registration route (Class A/B), and it governs how much clinical and technical data the reviewing authority expects to see. Devices are classified based on intended use, duration of body contact, and degree of invasiveness, following globally-referenced risk rules rather than an arbitrary product list.
Because CDSCO recognises certain established international approvals (such as CE marking under the EU framework) as supporting evidence within a device's technical file, manufacturers who already hold recognised overseas certification typically move through Indian classification and review faster than those building a technical file from scratch โ though Indian approval is always a separate, independent process, not an automatic recognition of the foreign certificate.
Products/Activities Covered
Who Needs It
Types & Categories
Class C
Moderate-to-high risk devices (e.g. certain imaging and diagnostic equipment).
Class D
Highest-risk devices (e.g. implants, life-support equipment), subject to the most stringent review.
Key Benefits
Documents Required
- CE Certificate or equivalent international approval
- ISO 13485 certification of the manufacturing site
- Device Master File with technical and clinical data
- Free Sale Certificate from the country of origin
- Labelling and instructions-for-use documentation
Our Process
Device Classification
We confirm the device's risk class (A/B/C/D) which determines the exact licensing route.
Technical File Compilation
Device Master File, test reports, and quality certifications are compiled for filing.
Overseas Approval Cross-Reference
Where the device holds CE or equivalent approval, we structure the filing to leverage that existing data within the Indian technical file.
MD-15 Filing
The import licence application is filed on SUGAM and tracked through to grant.
Query Resolution
We respond to any clinical or technical clarification requests raised during CDSCO's review.
Validity & Renewal
The MD-15 import licence is granted for 5 years from the date of issue and then effectively continues on an ongoing basis, provided a licence retention fee is paid before each successive 5-year mark โ missing that retention-fee window puts the licence at risk of being treated as lapsed, so we track the deadline and file the retention application well in advance.
Penalty for Non-Compliance
Importing or selling a Class C/D medical device without a valid import licence is an offence under the Medical Device Rules, 2017 (made under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940) โ carrying imprisonment of not less than three years, extendable to five, and a fine of not less than โน1,00,000 or three times the value of the devices confiscated, whichever is more โ alongside customs seizure and market withdrawal.
Frequently Asked Questions
Do Class A devices also need an import licence?
Yes, technically โ MD-15 import licensing applies to all four risk classes (A through D), but Class A and B devices sit in a materially lower fee and documentation tier than Class C/D, which is why they're often described as a lighter 'registration' route in practice even though the same licence form governs both.
Does holding a CE certificate mean automatic approval in India?
No โ CE and similar international approvals can support your Indian technical file and speed up review, but CDSCO conducts its own independent classification and approval process.
Can a device's risk class change over time?
Yes โ CDSCO periodically updates classification guidance, and a device's classification can be revisited if its intended use or the applicable rules change, which may require a fresh or amended filing.
Is clinical data always required?
Higher-risk classes (particularly Class D) typically require more substantial clinical evidence than Class C; we scope the exact clinical data needs during classification.
What is the licence retention fee and when is it due?
It's a fee payable to CDSCO before each 5-year anniversary of the licence's grant to keep it in force โ since the licence itself has no separate fixed expiry beyond that cycle, missing the retention-fee window is the main way an otherwise-compliant licence can lapse, so we flag the deadline well ahead of time.
Ready to Get Compliant?
Talk to a compliance expert today โ free, no-obligation consultation.
- Free consultation
- Response within 2 hours
- No hidden fees