An overseas manufacturer enters India by determining the device's risk class under the Medical Devices Rules 2017 (A to D), appointing an Indian Authorised Agent who holds a wholesale licence and applies for the import licence in Form MD-14 (granted as MD-15) through the SUGAM portal with the manufacturer's technical dossier, quality-system evidence and free-sale or approval evidence from a reference country, complying with Indian labelling and UDI requirements, and then meeting post-approval change and adverse-event reporting obligations under the Materiovigilance Programme of India. Class A non-sterile, non-measuring devices follow a registration route rather than licensing.
Risk classes and authorities
The Medical Devices Rules 2017 place devices in four classes — A (low), B (low-moderate), C (moderate-high) and D (high) — using the parameters in the First Schedule and the device-wise classification notices CDSCO publishes. The class and the activity together decide the authority. Manufacturing of Class A and B devices is licensed by the State Licensing Authority; manufacturing of Class C and D, and all imports regardless of class, are licensed by the Central Licensing Authority at CDSCO. Class A devices that are non-sterile and non-measuring follow a registration route rather than licensing. Since the notification of all devices and the phased licensing that followed, with Class C and D licensing in force since 1 October 2023, every device meeting the definition is regulated.
Forms and licences
The forms are application-and-licence pairs, and they are not interchangeable.
| Activity | Class | Authority | Application | Licence or certificate |
|---|---|---|---|---|
| Manufacture for sale | A and B | State Licensing Authority | MD-3 | MD-5 |
| Manufacture for sale | C and D | Central Licensing Authority | MD-7 | MD-9 |
| Import | All classes | Central Licensing Authority | MD-14 | MD-15 |
| Sale, stock, exhibit or distribute (wholesale) | All classes | State Licensing Authority | MD-41 | MD-42 |
| Test licence (manufacture or import for testing, evaluation or clinical investigation) | As applicable | Central Licensing Authority | MD-12 or MD-16 | MD-13 or MD-17 |
Which row applies depends on class, device and activity, and the licensing authority can differ from what a secondary source says. The route map confirms the row for your device against the current rules and notices before anything is filed.
The Authorised Agent
An overseas manufacturer cannot hold an Indian import licence. The applicant is an Indian Authorised Agent — a company holding a wholesale licence for medical devices — acting under a power of attorney from the manufacturer. The licence is granted to the agent, who is answerable to CDSCO for the devices imported under it. Choosing the agent is therefore a commercial and regulatory decision at once: a distributor who holds your licence holds a strong position in any later renegotiation. The alternatives — an Indian subsidiary, or an independent agent with a separate distribution agreement — have their own costs. The route map sets out the options for your situation.
The dossier and SUGAM
Applications are made through CDSCO's SUGAM portal with the applicant's own credentials. The import dossier includes the device master file and plant master file in the structure the rules prescribe, the quality-system certificate (ISO 13485 is the norm), free-sale certificates or approvals from reference countries where available, labelling, the power of attorney and the agent's wholesale licence, and the fees per site and per device. Technical content prepared for the EU or the US serves well, re-organised into the Indian structure; the gap between a strong MDR file and a strong Indian dossier is mostly one of arrangement and local requirements rather than new evidence.
Allied requirements
Depending on the product, other Indian regimes apply alongside the Medical Devices Rules: Bureau of Indian Standards Quality Control Orders for product categories under mandatory certification; the Atomic Energy Regulatory Board for radiation-emitting equipment; the Wireless Planning and Coordination wing for radio-frequency products; and the Legal Metrology Act for packaged commodities. None applies to every device. The route map states which, if any, apply to yours and in what order they are obtained.
Post-approval obligations
Licences carry conditions: notification or prior approval of changes to the device, the site or the agent, as the rules classify them; compliance with Indian labelling and unique device identification requirements; record-keeping; and adverse-event reporting under the Materiovigilance Programme of India. The post-market surveillance pillar builds the Indian reporting annex into the manufacturer's single vigilance procedure.
Sequence of steps
- Determine the risk class from the First Schedule and CDSCO's classification notices.
- Decide the agent model — distributor, subsidiary or independent agent — and appoint the Authorised Agent under a power of attorney.
- Confirm the agent's wholesale licence (MD-42) or obtain it.
- Assemble the dossier in the Indian structure; adapt labelling.
- File the import licence application (MD-14) through SUGAM; respond to queries.
- On grant of MD-15: import, comply with allied requirements, and begin post-approval change control and Materiovigilance reporting.
Dated changes to know about
| Change | Date | Status | What it means for you |
|---|---|---|---|
| Amendment check against the current Medical Devices Rules and CDSCO notices | Signed off 8 November 2026 against the source register | Current | Form references, class routes and authority allocation on this page were verified against the CDSCO rules page and current notices at the review date. India amends these rules frequently; this page is reviewed every six months and on any notified amendment. |
| Licensing of all medical devices under the Medical Devices Rules | Phased since 2020 under the notification of all devices; Class C and D licensing in force since 1 October 2023 | In force | Every device meeting the definition is regulated; a device that was previously unregulated in India now needs a licence or registration before import or manufacture. |
Legal basis and references
| Reference | Edition or version cited | Where it applies |
|---|---|---|
| Medical Devices Rules 2017 | As amended, including the Medical Devices (Amendment) Rules of 2020 onwards | Classification (First Schedule), licensing (Chapter III and IV), labelling (Chapter VI), post-approval changes, adverse event reporting |
| Drugs and Cosmetics Act 1940 | As amended | Parent statute; the definition under which devices are notified as drugs |
| CDSCO classification notices and device lists | Current notices at the review date | Risk class per device type |
| SUGAM portal guidance | Current | Online application procedure |
| Materiovigilance Programme of India | Current guidance document | Adverse event reporting |
| Bureau of Indian Standards Quality Control Orders; AERB; WPC; Legal Metrology Act 2009 | As applicable to the product | Allied compliance where the product falls within scope |
Boundary
Authentcare prepares the dossier, maps the route and coordinates the Authorised Agent; CDSCO and the State Licensing Authorities decide. Applications are filed by the licence applicant through its own SUGAM credentials.