Importing medical devices into India requires compliance with the Medical Devices Rules, 2017 (MDR 2017) and the applicable requirements of the Central Drugs Standard Control Organisation (CDSCO). For medical devices requiring an import licence, the authorised agent of the overseas manufacturer submits an application in Form MD-14 to the Central Licensing Authority (CLA). Upon satisfaction of the applicable regulatory requirements, the import licence is granted in Form MD-15.
The application must be supported by the documents prescribed under the Fourth Schedule of MDR 2017, along with the applicable requirements under the Second Schedule. Depending on the device and regulatory pathway, the dossier may include the Power of Attorney (PoA), authorised-agent documents, Free Sale Certificate (FSC) or Marketing Authorisation, ISO 13485 certificate, Plant Master File (PMF), Device Master File (DMF), labelling, Instructions for Use (IFU), risk-management documentation, verification and validation data, and clinical or performance evidence, as applicable.
Applicants should first determine whether the device requires an import licence or falls under a separate registration framework. In particular, Class A non-sterile and non-measuring medical devices are subject to the applicable registration requirements rather than the standard import-licence pathway.
Because CDSCO reviews applications against the applicable provisions of MDR 2017, incomplete documentation, incorrect classification, inconsistent product information, inadequate technical evidence or deficiencies in regulatory certificates can result in queries, deficiencies, delays or rejection. A complete and internally consistent MD-14 dossier is therefore essential for a smoother regulatory review.
The Central Licensing Authority (CLA) examines the documents submitted with the application under the applicable provisions of MDR 2017, including the requirements of the Fourth Schedule. Where applicable, the assessment may also take into account an inspection of the manufacturing site.
The review may cover:
Under Rule 36 of MDR 2017, after examination of the submitted documents and, where applicable, the inspection report, the CLA may grant the import licence in Form MD-15 or reject the application, recording the reasons for rejection in writing. The rule provides for the decision within nine months from the date of application.
Therefore, applicants should not view the MD-14 process simply as an administrative filing. The quality, completeness and consistency of the regulatory dossier are critical.
Missing or improperly prepared documents can lead to CDSCO queries and deficiencies.
Depending on the applicable requirements, the dossier may require:
The names, addresses, signatures and other details should be consistent throughout the submission.
Where an FSC or Marketing Authorisation is required, it should satisfy the applicable CDSCO requirements.
Applicants should verify:
The current CDSCO requirements should always be checked because FSC/Marketing Authorisation requirements can vary depending on the applicable regulatory circumstances.
Incorrect classification can create significant regulatory problems.
Medical devices in India are classified into Class A, B, C and D according to their risk under the First Schedule of MDR 2017.
Classification should be based on factors such as:
An overseas approval such as CE marking or US FDA clearance does not, by itself, determine the Indian classification.
Applicants should establish the applicable Indian classification before preparing the final MD-14 dossier.
The Fourth Schedule of MDR 2017 contains the applicable requirements for the Plant Master File and Device Master File.
Depending on the nature of the device, the DMF may include:
The PMF generally covers applicable information relating to:
The documents should be device-specific, current and consistent with the information submitted elsewhere in the application.
Labelling and Instructions for Use (IFU) must comply with the applicable requirements of Chapter VI and the Seventh Schedule of MDR 2017, together with any subsequent applicable regulatory requirements.
Applicants should check, as applicable:
Labelling information should be consistent with the DMF, FSC/Marketing Authorisation, MD-14 application and other technical documentation.
One of the most preventable causes of regulatory deficiency is inconsistency between documents.
Applicants should cross-check:
Information should be consistent across Form MD-14, DMF, PMF, FSC/Marketing Authorisation, PoA, ISO certificate, labels, IFU and other supporting documents.
Even seemingly minor inconsistencies can result in clarification requests and delay the review.
An overseas manufacturer must appoint an appropriate Indian authorised agent in accordance with MDR 2017.
Depending on the applicable requirements, the authorised agent should hold the relevant:
The application should also include the applicable Power of Attorney and undertaking.
The legal name and address of the authorised agent should be consistent across the PoA, MD-14, licence documents and other regulatory records.
Clinical and performance-evidence requirements should be assessed based on the device classification, regulatory status, country of origin and applicable pathway under MDR 2017.
The requirements are not identical for every Class C or Class D device.
In particular, Rule 36 provides different requirements depending on factors such as the country from which the device is imported and the availability of applicable regulatory certification.
Therefore, applicants should assess the specific clinical/performance-evidence pathway applicable to their device instead of assuming that every high-risk device requires an identical clinical package.
After submission, CDSCO may raise queries or request additional information.
Applicants should:
Incomplete or poorly structured responses can lead to additional queries and prolong the regulatory review.
Before filing an application, applicants should confirm that they are using the correct regulatory pathway and applicable form.
The applicant should assess:
The absence of a predicate device should not by itself be treated as a reason to replace MD-14 with MD-26. The applicable regulatory pathway must be determined based on the specific device and circumstances under MDR 2017.
Start with the latest applicable CDSCO MD-14 checklist, MDR 2017 and relevant CDSCO FAQs/notifications.
Determine whether the device is Class A, B, C or D according to the First Schedule of MDR 2017.
Also determine whether a Class A device falls under the applicable registration framework.
Determine whether the device requires:
Prepare the Plant Master File and Device Master File according to the applicable requirements of the Fourth Schedule.
Check the validity, issuing authority, authentication and product details of applicable:
Ensure that the PoA and undertaking are properly executed and authenticated according to applicable CDSCO requirements.
Ensure that all applicable MDR 2017 labelling requirements are addressed and that the information is consistent with the DMF and other regulatory documents.
Perform a comprehensive comparison of the information in:
MD-14 → DMF → PMF → FSC/MA → PoA → ISO certificate → Labels → IFU → Technical documents
Determine the evidence requirements according to the applicable Rule 36 pathway, device classification and country of origin.
Before uploading the application, conduct an independent technical, regulatory and document-quality review to identify gaps before CDSCO identifies them.
Where an overseas manufacturing-site inspection is applicable, ensure that the manufacturing facility, QMS, production processes and technical documentation are prepared for regulatory inspection.
Track the application on the CDSCO portal and provide complete, accurate and timely responses to any regulatory queries.
The regulatory review may involve inspection of an overseas manufacturing site where applicable under MDR 2017.
Manufacturers should therefore maintain readiness with respect to:
Where an inspection is conducted, the applicable inspection report may form part of the basis for consideration of the import-licence application.
Once granted, an import licence under MDR 2017 remains valid in perpetuity, subject to the applicable requirements, including payment of the prescribed retention fee, unless the licence is cancelled or surrendered in accordance with the rules.
Licence holders should therefore maintain ongoing compliance rather than treating MD-15 approval as the end of their regulatory obligations.
Obtaining an import licence for a medical device in India requires more than submitting Form MD-14. Applicants must ensure that the correct regulatory pathway, device classification, authorised-agent documentation, PMF, DMF, regulatory certificates, labelling, clinical/performance evidence and other supporting documents comply with the applicable requirements of MDR 2017 and current CDSCO requirements.
Many regulatory deficiencies can be prevented through accurate classification, complete documentation, proper authentication, consistent product information and a thorough pre-submission review.
For devices requiring an import licence, successful completion of the MD-14 application process and grant of Form MD-15 provide the regulatory basis for importation, but ongoing compliance obligations continue after approval.
A carefully prepared and query-ready CDSCO dossier can help reduce avoidable deficiencies, minimise regulatory delays and establish a stronger foundation for continued medical-device compliance in India.
Last Updated : 09 Sep 2026
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