CDSCO License Endorsement: When and How to Update Your Medical Device Import License

The Indian medical device regulatory framework under the Medical Devices Rules 2017 requires every importer and authorised agent to keep their licences current and accurate. A CDSCO import license granted in Form MD-15 after submission of Form MD-14 remains valid in perpetuity provided the licence retention fee is paid every five years. When an existing licence holder needs to add new devices, models, variants or additional manufacturing sites of the same legal manufacturer, the proper route is a CDSCO license endorsement rather than a completely new application.

What is CDSCO License Endorsement?

Under the Medical Devices Rules 2017, endorsement means adding additional medical devices or, in permitted cases, additional manufacturing sites to an already approved Form MD-15 license. The application continues to be filed as a Form MD-14 application, but it is clearly marked and processed as an endorsement linked to the existing base licence number.

The endorsement remains valid only as long as the base MD-15 licence is valid. When the five-year retention of the base licence falls due, all endorsements must be retained together with it.

When is Endorsement Required?

Endorsement is the correct path in these situations:

• Adding new products, models or variants manufactured at the same legal and actual manufacturing site already covered by the existing MD-15 licence.
• Expanding the product list under the same Indian Authorized Agent medical devices and the same overseas manufacturer.

Endorsement is not appropriate when there is a change in the constitution of the licensee, a change of overseas manufacturer or a change of authorised agent. In those cases a fresh application is mandatory.

How to Apply for CDSCO License Endorsement – Step-by-Step

1. Confirm that the base MD-15 licence is valid and that the new devices share the same legal manufacturer (and normally the same actual manufacturing site). The authorised agent must hold a valid wholesale or manufacturing licence or registration certificate in Form MD-42.
2. Log into the SUGAM/CDSCO portal (CDSCO Medical Devices Online Portal). Select the endorsement option against the existing licence number and complete the Form MD-14 carefully, stating that it is an endorsement and quoting the base licence number.
3. Pay the prescribed fee as per the Second Schedule of the Medical Devices Rules 2017. Only the additional product fee (and site fee if a new site is added) is normally required.
4. Prepare and upload the documents listed in the official CDSCO endorsement checklist. Key items include:
   • Covering letter mentioning the base licence number and purpose.
   • Form MD-14 application.
   • Fee challan.
   • Power of Attorney with undertaking from the authorised agent (Part I of the Fourth Schedule), duly authenticated.
   • Copy of the existing Form MD-15 licence.
   • Free Sale Certificate medical device / Marketing Authorisation from the country of origin (notarised) and preferably from reference countries (USA, UK, EU, Canada, Japan or Australia).
   • ISO 13485 certification CDSCO or equivalent Quality Management System certificates for the manufacturing site (notarised).
   • Declaration of Conformity issued by the manufacturer.
   • Undertaking from the overseas manufacturer that there is no major change in the existing Plant Master File PMF. If major changes exist, the full PMF as per Appendix I of the Fourth Schedule must be submitted.
   • Device Master File DMF CDSCO prepared as per Appendix II of the Fourth Schedule for the additional devices (executive summary, specifications, labelling, risk analysis, verification & validation, clinical evidence if applicable, etc.).
   • Any class-specific or device-specific data (biocompatibility, sterilisation validation, software validation, etc.).
5. Submit the complete dossier online. CDSCO may raise queries; respond within the given timelines. The statutory period for grant of an import licence is up to nine months when documents are satisfactory; well-prepared endorsement applications for additional products of the same site are frequently processed more quickly.
6. On approval, CDSCO issues the endorsement linked to the original MD-15 licence number. The newly added products can then be legally imported.

Correct CDSCO medical device classification (Class A, B, C or D) of the additional devices is essential before filing, because fees, documentation depth and review intensity depend on the risk class.

Validity of Endorsement and Retention

Official CDSCO FAQs confirm that any endorsement remains valid only until the validity of its base licence. The base MD-15 licence itself continues in perpetuity subject to timely payment of the licence retention fee every five years from the date of issue of the base licence. All endorsements must be retained simultaneously with the base licence. Failure to pay the retention fee results in the licence and every endorsement attached to it being deemed cancelled after the prescribed grace period.

Why Choose MDR Consultants for Your CDSCO License Endorsement?

Medical device registration India and subsequent licence maintenance demand precise knowledge of CDSCO procedures, document authentication requirements and portal workflows. MDR Consultants provide end-to-end support for CDSCO regulatory compliance, including:

• Accurate classification and grouping of additional devices.
• Preparation of complete technical dossiers (Device Master File and Plant Master File).
• Guidance on notarisation, apostille and Power of Attorney formalities.
• Portal filing, fee calculation and prompt query management.
• Timely retention of base licences together with all endorsements.

We help authorised agents and foreign manufacturers avoid common causes of delay such as incomplete Free Sale Certificates, missing undertakings or incorrect fee payments. Whether you need a straightforward product addition or a more complex Import license amendment India, our team ensures the submission meets current CDSCO expectations.

Conclusion

A CDSCO license endorsement is the efficient, legally prescribed method to expand an existing medical device import licence under the Medical Devices Rules 2017. By filing a properly prepared Form MD-14 endorsement application with the required documents, importers can add new products or sites without restarting the entire licensing process. Maintaining the base licence through timely retention fee payment is critical, because every endorsement depends on the continued validity of that base licence.

Staying compliant protects uninterrupted market access, prevents customs clearance problems and ensures continuous supply of essential medical devices in India. For accurate, up-to-date assistance aligned with official CDSCO checklists and the Medical Devices Rules 2017, partnering with experienced regulatory consultants remains the most reliable approach.

Last Updated : 17 Sep 2026