CDSCO Registration for Medical Devices in India

CDSCO registration is the legal gateway to the Indian market for every medical device and IVD. Whether you manufacture in India, import from overseas or distribute devices, you need the right CDSCO license before a single unit is sold. As an experienced CDSCO consultant, Medfins International identifies the correct licence, prepares the dossier, files it on the CDSCO portal and manages queries through to grant.

What is CDSCO registration for medical devices?

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices and in vitro diagnostics under the Medical Devices Rules, 2017. “CDSCO registration” is the everyday name for the licences, registrations and permissions those Rules require. Since October 2023, licensing applies to medical devices of every risk class, so a device that was once unregulated now needs a valid CDSCO license to be manufactured, imported or sold in India.

Devices are classified as Class A (low risk), Class B (low-moderate), Class C (moderate-high) or Class D (high risk). The class decides which authority reviews your application, which forms apply, the government fee and how much evidence CDSCO expects. Use our free CDSCO device classification tool to see the likely class of your device before you start.

Which CDSCO license do you need?

Overseas manufacturers cannot apply in their own name; the import licence is held by an Indian authorised agent. New devices with no predicate in India need separate permission before licensing, and certain Class A non-sterile, non-measuring devices follow a simplified online registration route instead of a full licence.

Detailed guides for each CDSCO license

• Medical device manufacturing license in India (MD-5 and MD-9)
• CDSCO import license (MD-15) for foreign manufacturers
• CDSCO test license for medical devices (MD-13 and MD-17)
• Medical device wholesale license (MD-42 registration)
• IVD registration and IVD import license in India

The CDSCO registration process, step by step

1. Classify the device using the First Schedule rules and CDSCO’s published classification lists, and confirm whether it is a new device.
2. Choose the licence route – manufacturing, import, test or wholesale – and, for imports, appoint the Indian authorised agent.
3. Prepare the dossier: Device Master File, Plant Master File, ISO 13485 evidence, labels and instructions for use, test reports and the essential principles checklist.
4. File online on the CDSCO medical device portal with the government fee under the Second Schedule.
5. Audit or review: a notified body audit for Class A and B manufacturing sites, or a CDSCO inspection and technical review for Class C and D and imports.
6. Respond to queries within the time allowed, with clear cross-references to the dossier.
7. Grant and maintain: pay the licence retention fee every five years, file post-approval changes and meet post-market surveillance duties.

Documents required for CDSCO registration

• Device Master File and Plant Master File in the Fourth Schedule format
• ISO 13485 certificate or QMS evidence for each manufacturing site
• Free sale certificate from the country of origin (for imports)
• Power of attorney and authorised agent undertaking (for imports)
• Labels, instructions for use and the essential principles of safety and performance checklist
• Test reports, biocompatibility, sterilisation and stability data as applicable
• Clinical evidence or performance evaluation where the class or device type requires it

CDSCO registration fees

Government fees are set by the Second Schedule of the Medical Devices Rules, 2017 and are charged per site plus per device. The commonly applied amounts are shown below; we confirm the current fee for your exact application in our proposal, as CDSCO can revise them.

Consulting fees depend on the number of devices, sites and the state of your technical documentation. Ask us for a fixed-fee quotation.

How long does CDSCO registration take?

Timelines depend on class, dossier quality and query rounds. A well-prepared Class A or B manufacturing application usually completes in a few months, while import licences and Class C and D manufacturing licences commonly take longer because of deeper technical review. The single biggest cause of delay is an incomplete Device Master File, which is why we review every dossier against CDSCO’s checklist before filing.

Why choose Medfins as your CDSCO registration consultant?

• 175+ regulatory projects delivered for 250+ medical device products and 100+ clients
• End-to-end support: classification, dossier, portal filing, audits, queries and post-approval changes
• Indian authorised agent services with our own MD-42 registered premises in Chennai
• One team for India, EU MDR, US FDA and GCC/ASEAN registrations, so your dossier is built once and reused

Ready to start? Book a free consultation with Medfins International or call +91 85270 48221.

Frequently asked questions