CDSCO Medical Device Registration

Overview Requirement Documents procedure Fees Benefits FAQ

Introduction

CDSCO regulates every medical device sold, manufactured, or imported in India under the Medical Devices Rules, 2017. The license form you need depends on your role: importers apply on Form MD-14 and receive Form MD-15; Indian manufacturers of Class A/B devices use Form MD-3 to get Form MD-5; Class C/D manufacturers apply on Form MD-7 for Form MD-9; wholesalers and distributors need Form MD-41 for the Form MD-42 license; and businesses needing devices purely for testing, clinical evaluation, or training apply for a test license on Form MD-12 to receive Form MD-13. All applications are filed online through the CDSCO SUGAM portal.

What Is CDSCO Medical Device Registration?

If you manufacture, import, or distribute medical devices in India, CDSCO registration is not optional — it is a legal requirement under the Medical Devices Rules, 2017 (MDR 2017), notified under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organization (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health & Family Welfare, is India's national regulator responsible for approving every notified medical device before it reaches the market.

Unlike a single, one-size-fits-all certificate, CDSCO medical device registration works through a specific set of forms, and the form you need depends entirely on your role in the supply chain and the risk class of your device. A Class A thermometer manufacturer follows a very different path than a Class D implant importer, even though both fall under the same regulatory framework. Choosing the wrong form is one of the most common — and most expensive — mistakes businesses make, since it usually means restarting the entire application on the SUGAM portal.

Types of CDSCO License

Here is a quick summary of which CDSCO form applies to which business role, and which authority grants the final license.

Medical Device Classification: Class A, B, C & D

Every notified medical device in India is classified into one of four risk-based categories under MDR 2017. This classification decides which manufacturing or import form applies to your product, and how much documentation CDSCO expects.

Non-sterile, non-measuring Class A devices are exempt from full licensing under MDR 2017, but they still require self-certification and registration on the SUGAM portal — they are not entirely outside the system.

Product Categories Covered Under CDSCO Medical Device Licensing

CDSCO's licensing regime spans a wide range of device categories, each mapped to a risk class based on intended use. Broad categories commonly registered under MDR 2017 include:

The exact classification of your specific product should always be verified against the current MDR 2017 Schedule and CDSCO's SUGAM device database before you select an application form.

Complete Breakdown of Each CDSCO License Form

MD-3 & MD-5 — Manufacturing License for Class A & Class B Devices

MD-7 & MD-9 — Manufacturing License for Class C & Class D Devices

MD-14 & MD-15 — Import License for Medical Devices (Any Class)

MD-41 & MD-42 — Wholesale License for Distribution

MD-12 & MD-13 — Test License for Evaluation, Demonstration & Training

Documents Required for CDSCO Registration

Document requirements vary by form and device class, but most applications draw from this common checklist:

Step-by-Step CDSCO SUGAM Portal Registration Process

2026 update: CDSCO issued a public notice in January 2026 targeting long-pending SUGAM applications across the Medical Devices, IVD, and Biologics divisions. Applications with unresolved queries are now rejected — and fees forfeited — if applicants don't respond within a strict 30-day window after the fourth and final reminder. Timely query response has never mattered more.

CDSCO Medical Device License Fees

Manufacturing license fees (Class A/B and Class C/D) are charged per manufacturing site plus per device:

Import license fees (MD-14/MD-15) for foreign manufacturers are charged in USD, per manufacturing site plus per device:

Wholesale license (MD-41/MD-42) fees are generally lower and can vary by state — confirm the current schedule with your State Licensing Authority. Test license (MD-12/MD-13) fees are charged per distinct device under the Second Schedule of MDR 2017 and are typically nominal compared to full manufacturing or import fees. Fee schedules are revised periodically, so always verify current rates on the official CDSCO SUGAM portal before filing.

Processing Timeline by License Type

Complex, innovative, or first-of-its-kind devices can take 9-12 months or longer, mainly due to additional clinical data requirements and regulatory review cycles.

Validity, Renewal & Retention Fee Rules (2026)

A common misconception is that CDSCO licenses expire after 3-5 years. In reality, licenses such as MD-5, MD-9, MD-15, MD-42, and MD-13 are valid in perpetuity, provided the holder pays a retention fee every five years from the date of issue and submits updated documents confirming no unapproved changes to the device or manufacturing process.

Benefits of CDSCO Medical Device Registration

Common Reasons CDSCO Applications Get Rejected or Delayed

Why Businesses Choose Silvereye Certifications for CDSCO RegistrationWhy Businesses Choose Silvereye Certifications for CDSCO Registration

Navigating CDSCO's form-based system — choosing between MD-3, MD-7, MD-14, MD-41, or MD-12, assembling the right Device Master File, and tracking SUGAM queries within CDSCO's strict response windows — is easy to get wrong without regular hands-on experience with the portal. Silvereye Certifications works with manufacturers, importers, and wholesale distributors across device classes to identify the correct license pathway, prepare compliant documentation, and manage the application through to grant of license — helping businesses avoid the delays and rejections that come from an incomplete or misclassified filing.

Frequently Asked Questions

Do I need CDSCO registration to sell medical devices online in India?

Yes. Any device notified under MDR 2017 must carry a valid CDSCO license before it is sold through any channel, including e-commerce, regardless of its risk class.

What is the difference between MD-14 and MD-15?

MD-14 is the application form filed by the importer or Authorised Indian Agent. MD-15 is the import license granted once CDSCO approves that application.

Can a foreign manufacturer apply for a CDSCO license directly?

No. Foreign manufacturers must appoint an Authorised Indian Agent, who holds a valid wholesale license (MD-42), to file the import application on their behalf.

How long is a CDSCO medical device license valid?

Licenses such as MD-5, MD-9, MD-15, and MD-42 are valid in perpetuity, but a retention fee must be paid every five years from the date of issue to keep them active.

What happens if I miss the CDSCO retention fee deadline?

A late fee of roughly 2% per month applies. If the payment window lapses entirely — up to 180 days for licenses — the license is deemed automatically cancelled.

Which form do I need to import medical devices only for clinical trials?

Import for clinical investigation, testing, or training uses Form MD-16 (application) and MD-17 (license) — separate from the commercial import license (MD-14/MD-15).

Is registration mandatory for Class A devices?

Non-sterile, non-measuring Class A devices are exempt from full licensing but still require self-certification and registration on the SUGAM portal

How long does CDSCO approval take for Class D devices?

Class D devices, being highest-risk, typically take 6-9 months or longer, especially if clinical data or biocompatibility reports need revision.

Can a wholesaler apply for an import license?

A wholesaler holding a valid MD-42 license can act as the Authorised Indian Agent and file the import application on behalf of a foreign manufacturer.

What documents are needed for nearly every CDSCO application?

A Device Master File, a Plant Master File (for manufacturers), business identity proof, and applicable quality certificates are required across almost all forms.