India CDSCO Medical Device Rules 2017: Classification, Licences and Import Registration

India has one of the fastest-growing medical device markets in the world, and since the Medical Devices Rules 2017 became fully effective, every class of device now sits inside a licensing system run by the Central Drugs Standard Control Organisation (CDSCO). For global manufacturers, the central questions are practical: which class is my device, who grants the licence, what is the import route, who must be my local agent, and what must I prepare. This guide answers them in order and shows how existing FDA or CE evidence can help.

The legal framework

Medical devices are regulated under the Drugs and Cosmetics Act 1940 and the Medical Devices Rules 2017, which came into force in January 2018. In the first years, only notified categories of devices needed licences. The rules were then phased in so that all devices are regulated: licensing for Class A and B devices became mandatory in October 2022, and for Class C and D devices in October 2023. In vitro diagnostics follow the same rules with their own classification and forms.

CDSCO acts as the Central Licensing Authority. State licensing authorities handle manufacturing licences for lower-risk devices. Quality system expectations are based on ISO 13485 and are set out in the rules.

Risk classes and who licenses what

Class	Risk	Manufacturing licence authority	Forms (application / licence)
A	Low	State authority for sterile or measuring devices; registration on the online portal for non-sterile, non-measuring devices	MD-3 / MD-5 where a licence applies
B	Low to moderate	State licensing authority	MD-3 / MD-5
C	Moderate to high	Central licensing authority (CDSCO)	MD-7 / MD-9
D	High	Central licensing authority (CDSCO)	MD-7 / MD-9

The rules also provide loan licence forms for products manufactured under another company’s licence. CDSCO publishes risk-based classification lists by device category, so the first step for any product is to find the entry that matches your intended use. If your device is not listed, ask CDSCO how it will be classified. Our guide to device classification explains how to document a classification rationale, which also supports an Indian query.

Importing into India: Form MD-14 and MD-15

A foreign manufacturer cannot sell into India without an import licence. The process works like this:

1. Appoint an Indian authorised agent. The agent is a legal entity in India that holds the required wholesale licence and acts as the regulatory contact for CDSCO. The agent applies for the import licence on the manufacturer’s behalf.
2. Apply in Form MD-14 through CDSCO’s online system. The application covers the manufacturer, the manufacturing site and the devices, and is submitted with the supporting documents.
3. Receive the licence in Form MD-15 from the Central Licensing Authority once the application has been reviewed. CDSCO may inspect an overseas site at its discretion.

Import licences cover a defined list of devices and manufacturing sites. Adding a device or a site later needs an application or amendment. Licences are generally valid in perpetuity, subject to payment of a retention fee at five-year intervals and continued compliance with the conditions of the licence. Check the current rule text, because details such as fees and timelines are updated by amendment.

What to prepare: the technical dossier

The core documents will look familiar to anyone who has built a technical file:

• Device Master File (DMF): device description, design, specifications, risk management, verification and validation, clinical evidence and labelling.
• Plant Master File (PMF): the manufacturing site, its quality system and its processes.
• Quality system evidence: a certificate to ISO 13485, or an equivalent, for the manufacturing sites, together with evidence of implementation.
• Free Sale Certificate: evidence that the device is legally marketed in its country of origin or in a reference country such as the US, EU, UK, Canada, Australia or Japan. A device approved in one of these reference markets may be considered for relief from additional local clinical investigation.
• Labelling: in the form required by the rules, with the details of the manufacturer, the importer and the licence.
• Power of attorney and declarations that connect the manufacturer and the authorised agent.

If you already have a mature design file and ISO 14971 risk file, most of the DMF content can be adapted rather than rewritten. Software and electrical devices bring additional standards: see IEC 60601 safety and EMC and our SaMD training pages for the software side.

Clinical evidence

For many Class C and D devices, clinical investigation or performance evaluation is part of the approval, unless an exemption applies. Waivers are commonly linked to approval in reference countries and to the strength of existing clinical data. Plan the evidence strategy early, and align your Indian rationale with the clinical evaluation you already have for the EU. Our guide to clinical evaluation under EU MDR can help you structure the argument that existing evidence is sufficient.

Timelines and costs

Timelines depend on class and completeness of the file. Lower-risk import applications often move in a matter of weeks to a few months, while Class C and D applications can take several months or longer, especially when questions or inspections are involved. Government fees depend on class, the number of devices and sites, and they are set in a schedule in the rules, so check the current schedule rather than relying on older tables. Budget separately for the authorised agent’s services, translations where needed, and any local testing.

After you are licensed

• Post-market obligations. Licence holders must maintain complaint and adverse event handling, report serious events, and operate recalls when needed. Link your Indian reporting to the CAPA and complaint process that you already use.
• Changes. Major changes to the device, site or manufacturer need prior approval or notification under the rules. Use a documented change assessment, as described in our change control guide.
• Labels and traceability. Maintain labelling that meets Indian requirements and keep records that allow traceability. See UDI for how identification systems are built.
• Audits and inspections. Be ready for inspections of the authorised agent and, where required, of the manufacturing site.

A practical plan for a foreign manufacturer

1. Find the device in CDSCO’s classification list, or request classification if it is not listed.
2. Choose an Indian authorised agent with the right licences and regulatory experience, and agree who holds which documents.
3. Confirm your quality system certificate scope and gather the Free Sale Certificates from reference markets.
4. Build the Device Master File and Plant Master File from your existing technical file, adding Indian labelling.
5. Decide the clinical evidence position and whether a waiver or local study is needed.
6. Submit Form MD-14, respond to queries quickly, and plan for a possible site inspection.
7. After the MD-15 is issued, set up retention fee reminders, change control and post-market reporting.

Common mistakes

• Assuming Class A devices are fully outside the rules. Only non-sterile, non-measuring Class A devices follow the lighter registration route.
• Starting the application before the quality system certificate and Free Sale Certificates are ready.
• Choosing an agent only on price, without checking their licences and their ability to handle queries.
• Selling a modified model or from a new site that is not on the licence.
• Ignoring local labelling rules until the end of the project.

Frequently asked questions

Do all medical devices need a CDSCO licence?

All devices are now within the rules, but non-sterile, non-measuring Class A devices follow a registration route on the online portal rather than a full licence. All other classes need a manufacturing licence or an import licence.

Can an overseas manufacturer apply directly?

An Indian authorised agent is part of the standard import process, and the agent files the application for the manufacturer. Confirm the current arrangement with CDSCO.

Does an FDA or CE approval remove the need for an Indian licence?

No. It supports the application and can reduce local clinical requirements, but an import licence is still required.

Does the import licence expire?

Licences are generally valid in perpetuity, with a retention fee due at five-year intervals and ongoing compliance required. Verify the present rule text, since amendments change details.

India’s rules and fee schedules are updated by notification and CDSCO guidance. This article is a training overview reflecting information available in November 2026. Confirm current requirements with CDSCO and your regulatory advisers.

Related reading

• Global market access beyond the US and EU: how India fits with other markets.
• Device classification: building a classification rationale.
• ISO 13485 and MDSAP audit readiness: quality system evidence for global markets.
• RA Certificate Course: structured training in global regulatory affairs.
• Medical device career mentoring: building a regulatory career in India and abroad.

Talk to the AptSkill team

Want training in India’s Medical Devices Rules, or help planning a CDSCO submission strategy? Send us your role and goal.