Exporting Medical Devices to India: CDSCO Import Licence Steps under MDR 2017

Direct answer: India does not recognise foreign registration certificates; market access is granted solely through an Indian import licence. Under Chapter V of the Medical Devices Rules, 2017 (G.S.R. 78(E)), an authorised agent holding an Indian manufacturing and sale licence or wholesale sale licence must apply to the Central Licensing Authority (CLA, i.e. CDSCO) in Form MD-14. The CLA then grants the import licence in Form MD-15, with a statutory decision period of nine months. The licence remains valid in perpetuity, subject to payment of a licence retention fee every five years for each manufacturing site and each licensed device.

Key requirements

Competent authority

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, is the competent authority. The Central Licensing Authority (CLA) functions through the Drugs Controller General (India), DCGI. Official portal: https://cdsco.gov.in/

Products covered

Devices are classified as Class A, B, C or D under Rule 4 and the First Schedule of the Medical Devices Rules, 2017, with Class A carrying the lowest risk and Class D the highest; in vitro diagnostic devices are subject to separate classification rules. Manufacturing licences for Class A and Class B are issued by the State Licensing Authority (SLA), while Class C and Class D are handled by the CLA. Import licences are always handled by the CLA, irrespective of class.

Core documentation

• Application in Form MD-14 together with the fee prescribed in the Second Schedule.
• Power of attorney and undertaking from the agent as set out in Part I of the Fourth Schedule, authenticated in India before a First Class Magistrate or an Indian embassy or consulate abroad, or apostilled.
• Copy of the authorised agent's manufacturing and sale licence or wholesale sale licence.
• Quality management system certification of the overseas manufacturing site (ISO 13485).
• Device technical file, labels and instructions for use.
• Clinical evidence, where applicable.
• Batch release certificates or test reports for at least three consecutive batches.
• Proof of marketing approval in the country of origin, where applicable.

Validity of the licence

An import licence in Form MD-15 is valid in perpetuity and carries no expiry date. A licence retention fee must nevertheless be paid every five years from the date of issue, calculated per overseas manufacturing site and per licensed device; payment may be made within 90 days of the due date with a late fee, and non-payment may result in cancellation of the licence. Any change in the constitution of the firm or the licensee must be followed by a fresh application within 180 days (Rule 39).

Local representative required

Yes. An overseas manufacturer cannot apply on its own behalf and must appoint an Indian authorised agent. The agent must itself hold a manufacturing and sale licence or a wholesale sale licence under the Medical Devices Rules, 2017, and holds the licence in its own name. A change of agent requires a fresh import licence application; a mere variation or notification is not sufficient.

Regulatory background

The Medical Devices Rules, 2017 were notified by the Ministry of Health and Family Welfare as G.S.R. 78(E) on 31 January 2017, published in the Gazette of India, Part II, Section 3, Sub-section (i). They were framed under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and came into force on 1 January 2018 unless otherwise provided (Rule 1).

Official text (CDSCO, 211 pages): https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf

Chapter V, Import of Medical Devices, comprises Rules 34 to 39:

• Rule 34: the authorised agent applies in Form MD-14 through the online portal designated by the Ministry of Health.
• Rule 35: the CLA may depute officers to inspect the overseas manufacturing site, with costs borne by the applicant in accordance with the Second Schedule.
• Rule 36: after scrutiny, the CLA grants the licence in Form MD-15 or rejects the application in writing within nine months from the date of application; a rejection may be appealed to the Central Government within 45 days.
• Rule 37: the licence is valid in perpetuity, provided the five-yearly licence retention fee is paid for each site and each device.
• Rule 39: following a change in constitution, a fresh application must be made within 180 days, and the existing licence is deemed valid until the new licence is issued.

The official document list, Checklist for the grant of Import license in Form MD-15, covers 11 categories of documents, including the mode of authentication of the power of attorney, the agent's licence and batch release certificates: https://www.cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/14MD.pdf

CDSCO medical device FAQs (including change of agent): appointment of a new Indian agent requires a fresh import licence application; any change in the constitution or address of the agent or the overseas manufacturer must be notified in writing to the CLA within 45 days. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/MDFA13feb.pdf

Classification basis: Rule 4 and the First Schedule. The classification list is published by the CLA and is available on the CDSCO website. The class applicable to a given product in India is determined by the CLA classification list and case-by-case assessment; foreign classification outcomes are not accepted as directly transferable.

Verification date: 2 November 2026.

Frequently asked questions

Can a device be sold in India on the basis of a CE or FDA certificate?

No. A CE mark or FDA clearance forms part of the technical documentation only; market access requires an import licence in Form MD-15. India reclassifies devices under its own rules, and the Indian class may differ from the classification applied in the European Union.

Can an overseas manufacturer apply in its own name?

No. Rule 34(1) limits the applicant to an authorised agent holding an Indian manufacturing and sale licence or wholesale sale licence. The manufacturer can only issue a power of attorney, and the licence is held by the agent.

Must the import licence be renewed annually?

No annual renewal is required, but a licence retention fee is payable every five years. Fees are calculated per overseas manufacturing site and per device, and additional models require a separate application rather than being covered automatically.

Is changing the Indian agent straightforward?

It is more burdensome than commonly assumed. CDSCO has confirmed that appointing a new Indian agent requires a fresh import licence application, and the existing licence cannot be transferred. Supply interruptions during the handover period are a real risk, so transition timelines should be planned well in advance.

How long does the process take?

The rules provide that the CLA shall decide within nine months from the date of application. Actual timelines depend on the completeness of the dossier and on whether an overseas site inspection is triggered; time taken to remedy deficiencies is not counted, and no average processing time is publicly disclosed by the authority.

Must labelling include Indian local information?

Yes. Labels and instructions for use must state the name and address of the importer or authorised agent and must comply with the labelling provisions of the Medical Devices Rules, 2017. The specific layout must follow the labelling requirements currently applied by CDSCO; no single mandatory template is publicly available.

How Ameli supports clients

• Determining Class A, B, C or D under Rule 4 and the First Schedule, setting out whether an import licence or another route applies, and identifying the gaps against the 11 document categories required for Form MD-14.
• Tracking the authentication status of the power of attorney, the validity of the agent's licence, five-yearly retention fee due dates, and the mapping between overseas manufacturing sites and licensed devices, so that payments and add-on applications are not missed.
• Separating agent-side and manufacturer-side obligations into two parallel task lines and clarifying which document is pending with which party, reducing rejections caused by non-compliant power of attorney authentication.

Scope limitations

• Ameli does not act as an Indian authorised agent or licence holder, does not submit Form MD-14 on a client's behalf, does not obtain import licences and does not file as an agent or CRO.
• Ameli does not guarantee approval outcomes or processing times, does not substitute for the CLA or CDSCO in classification determinations, and does not cite fee amounts that have not been published.

Ameli is a regulatory affairs platform for medical device companies, covering product, regulatory, documentation, task, submission and certificate management; it is not a CRO and not an agent. All facts on this page are based on official sources, and figures that are not publicly disclosed are marked accordingly.