If you manufacture moderate-high or high-risk medical devices in India, Form MD-9 is your mandatory manufacturing Licence under the Medical Devices Rules, 2017. Without it, manufacturing and selling Class C or Class D devices is a regulatory violation — regardless of your company size or device type.
Form MD-9 is the Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices, issued by the Central Licensing Authority (CLA) — CDSCO under Rule 26 of the Medical Devices Rules, 2017 (MDR 2017).
To obtain MD-9, manufacturers must first apply using Form MD-7 (the application form) through the SUGAM online portal. Once reviewed, inspected, and approved by CDSCO, the MD-9 licence is issued — authorising the manufacturer to produce and commercially distribute their specified Class C or Class D medical devices from the approved manufacturing site.
Form MD-9 is the Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices, issued by the Central Licensing Authority (CLA) — CDSCO under Rule 26 of the Medical Devices Rules, 2017 (MDR 2017).
To obtain MD-9, manufacturers must first apply using Form MD-7 (the application form) through the SUGAM online portal. Once reviewed, inspected, and approved by CDSCO, the MD-9 licence is issued — authorising the manufacturer to produce and commercially distribute their specified Class C or Class D medical devices from the approved manufacturing site.
Important: Unlike Class A and Class B devices (which fall under State Licensing Authority jurisdiction), Class C and Class D devices are regulated directly by CDSCO — the Central Licensing Authority — due to their higher risk profile.
Under MDR 2017, all medical devices are classified into four risk-based categories. Class C and D represent the higher-risk tiers:
Class | Risk Level | Examples | Licensing Authority |
Class A | Low | Surgical dressings, thermometers, tongue depressors | State Licensing Authority (SLA) |
Class B | Low–Moderate | Hypodermic needles, suction equipment, hearing aids | State Licensing Authority (SLA) |
Class C | Moderate–High | Lung ventilators, bone fixation plates, haemodialysis machines, infusion pumps | CDSCO (Central) |
Class D | High | Heart valves, implantable defibrillators, neural stimulators, HIV diagnostic kits | CDSCO (Central) |
Correct classification is the foundation of your entire application. Misclassifying your device — even unintentionally — can lead to application rejection, requirement to restart the process, or post-licensing regulatory action.
Any person or entity intending to manufacture Class C or Class D medical devices in India for commercial sale or distribution must obtain MD-9. This includes:
Note: If you are importing Class C or Class D devices (not manufacturing), you need Form MD-15 (Import Licence) — not MD-9. Learn about MD-15 →
As per notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class C & Class D categories entered the mandatory licensing regime with effect from 01.10.2023. This means even devices that were previously unregulated or operating under transitional provisions now require a valid MD-9 licence for manufacturing.
Additionally, the CDSCO FAQ Addendum No. 03 (November 2025) provided further clarification on post-approval change procedures and documentation requirements — including updated guidance on sterilization outsourcing. As of DTAB’s 92nd meeting (April 24, 2025), manufacturers no longer need a separate loan licence for outsourcing sterilization — provided the sterilization facility already holds a valid MD-3 or MD-9 licence.
The application is submitted in Form MD-7 on the SUGAM portal. A complete, accurate dossier is the single biggest factor in avoiding CDSCO queries that delay approval. Required documents include:
Confirm your device falls under Class C or Class D as per Part I of the First Schedule of MDR 2017. This single step controls your entire application path — forms, inspection requirements, and fees. Getting classification wrong at this stage causes months of rework.
2. Obtain Test Licence (Form MD-12 → MD-13)
In certain cases, obtaining a Test Licence (MD-13) can help generate supporting data before applying for the full commercial MD-9 licence, but it is not mandatory for all applications. This allows you to manufacture small quantities for testing, evaluation, clinical investigation, or demonstration. Quality control data generated under a valid Test Licence strengthens your MD-9 application significantly.
3. Prepare Manufacturing Facility
Your facility must comply with Good Manufacturing Practices (GMP) as per MDR 2017 and the Quality Management System requirements of the Fifth Schedule. Prepare your Device Master File and Site Master File as per MDR 2017 format before applying — incomplete technical documentation is the most common cause of CDSCO queries and delays.
4. Register on SUGAM Portal & File MD-7 Application
Register on the SUGAM portal at cdscoonline.gov.in and select the Form MD-7 application. Fill in all device and facility details, upload the complete document dossier, and pay the applicable government fee online. Ensure every detail entered matches your supporting documents — any mismatch will trigger a CDSCO query.
5. CDSCO Review & Site Inspection
CDSCO reviews your submitted dossier. For Class C and Class D devices, a mandatory physical inspection of your manufacturing premises is conducted by CDSCO inspectors. They assess facility compliance with GMP and QMS requirements, staff qualifications, equipment adequacy, and documentation systems. If deficiencies are found, a query is raised and you must respond with corrective evidence.
6. MD-9 Licence Issued
Once the review and inspection are satisfactory, CDSCO issues the Form MD-9 Manufacturing Licence. The MD-9 licence is valid in perpetuity, subject to payment of retention fee every 5 years and continued compliance under MDR 2017. Each manufacturing site requires a separate MD-7 application and separate MD-9 licence — multiple sites cannot be covered under a single application.
Stage | Estimated Time |
Document preparation & facility readiness | 4 – 12 weeks |
SUGAM account approval | 3 – 5 working days |
CDSCO dossier review | 30 – 90 days (complete dossier) |
Site inspection scheduling & visit | 1 – 3 months (post review) |
Query response & re-review | +4 – 8 weeks per query cycle |
Total realistic timeline | 6 – 12 months (complete & accurate dossier) |
Fees: Application fees for Class C and Class D devices (MD-7) are higher than Class A/B, and vary by device type and number of devices. The fee structure is revised periodically by the Ministry of Health and Family Welfare. Contact us for the current applicable fee schedule for your specific device.
Mistake | Consequence |
Incorrect device classification (C vs D) | Wrong fee, wrong form — application rejected |
DMF/SMF not prepared as per MDR 2017 format | CDSCO query, significant delay |
QMS compliance undertaking missing | Mandatory for Class C/D — rejection without it |
Data mismatch between form and uploaded documents | Query raised, timeline extended by weeks |
Facility not ready before inspection | Failed inspection — re-inspection required |
Applying for all sites under one application | Rejection — separate application required per site |
No Test Licence data submitted | Weak application — queries on safety/performance |
Standards compliance not addressed | CDSCO expects BIS/ISO/IEC compliance evidence |
Obtaining an MD-9 licence for Class C or Class D devices is one of the most documentation-intensive regulatory processes in India’s medical device sector. Our team provides end-to-end support — from pre-application assessment to licence in hand:
Accurate Class C/D classification under MDR 2017 — before a single document is prepared.
Complete Device Master File and Site Master File preparation as per MDR 2017 format requirements.
Pre-inspection audit of your facility against MDR 2017 Fifth Schedule GMP requirements — close gaps before CDSCO visits.
End-to-end MD-7 application filing on SUGAM portal — accurate, complete, and ready for CDSCO review.
Complete, evidence-backed responses to CDSCO queries — addressing every point to avoid repeat queries.
Timely renewal filing and post-approval change management to keep your MD-9 licence current and compliant.
ISO 13485 is not an explicit mandatory requirement under MDR 2017. However, CDSCO may prefer or expect manufacturers to demonstrate ISO 13485 certification — particularly for higher-risk Class C and D devices. It is strongly recommended as it also supports compliance with US FDA and EU MDR requirements.
No. A separate MD-7 application along with requisite fees and documents is required for each actual manufacturing site. Each site receives its own MD-9 licence.
A Test Licence (MD-13) is not always mandatory before applying for MD-9, but it is strongly recommended. Quality control data generated under a valid Test Licence significantly strengthens your MD-9 application and reduces the likelihood of CDSCO queries on safety and performance data.
Realistically, 6 to 12 months from start to finish — including facility preparation, dossier compilation, CDSCO review, and site inspection. Incomplete applications or query response delays can extend this significantly. Starting with a complete, accurate dossier is the most effective way to minimise the timeline.
Failure to pay the retention fee may lead to suspension or cancellation of the MD-9 licence under MDR 2017. A late fee of 2% per month may apply for delayed payment, and prolonged non-payment may require a fresh application depending on CDSCO action.
Yes, absolutely. Final assembly, packaging, labelling, or sterilisation of medical device components within India — even if all parts are imported — requires a valid CDSCO manufacturing licence. This is explicitly stated in MDR 2017 and there are no exemptions to this rule.
Don’t let documentation gaps or facility deficiencies push your approval timeline by months. Our regulatory experts have handled Class C and Class D device applications across multiple product categories — and we know exactly what CDSCO looks for.
