CDSCO MD-15 Import License

Overview : CDSCO MD-15 Import License in India

A CDSCO MD-15 Import License allows an eligible Indian authorised agent to import specified medical devices and in-vitro diagnostic (IVD) medical devices into India. The application is submitted in Form MD-14, and the Central Licensing Authority may issue the import licence in Form MD-15 under the Medical Devices Rules, 2017.

The licensing route depends on the device's risk classification, intended use, overseas manufacturing site and applicable exemptions. Class A non-sterile, non-measuring medical devices follow a separate registration-based exemption framework rather than the ordinary MD-14/MD-15 licensing route.

Legal Papers India Business Solution Private Limited is a private business-registration and compliance consultancy. Businesses planning to import medical devices can contact the company to confirm the availability of CDSCO licensing assistance and request a quotation.

Contact Legal Papers India to discuss your proposed medical devices, overseas manufacturer and import requirements.

What Is a CDSCO MD-15 Import License?

Form MD-15 is the import licence issued by the Central Licensing Authority for medical devices covered by the applicable licensing provisions of the Medical Devices Rules, 2017.

An applicant submits Form MD-14 with the prescribed documents and government fees. CDSCO examines the application and determines whether the proposed products and overseas manufacturing arrangements meet the applicable requirements.

The licence is not a general permission to import every healthcare product. It covers the medical devices, manufacturing sites and particulars approved by the authority.

An MD-15 licence should not be confused with a pharmaceutical drug import licence, a medical device manufacturing licence or a licence for importing devices solely for testing or clinical investigation.
 

Who Needs an MD-15 Import License in India?

Businesses planning to commercially import regulated medical devices generally need the appropriate import authorisation unless a specific exemption applies.

• Indian Medical Device Importers
  An Indian business importing medical devices from overseas manufacturers must assess whether the products require an MD-15 licence and whether the applicant satisfies the authorised-agent requirements.
   
• Authorised Indian Agents of Foreign Manufacturers
  An overseas medical device manufacturer may appoint an eligible Indian authorised agent to submit the application and fulfil the responsibilities assigned under the Rules.
  The agency arrangement must be supported by the prescribed authorisation documents.
   
• Medical Device Distributors
  A distributor importing regulated devices directly from a foreign manufacturer must assess its import-licensing obligations separately from the permissions required for domestic sale or distribution.
  Holding a domestic sale registration or licence does not automatically replace the required import licence.
   
• Importers of In-Vitro Diagnostic Devices
  IVD devices, including relevant diagnostic test kits and reagents, are also regulated under the Medical Devices Rules.
  The precise licensing route depends on the product's classification, intended use and regulatory status.
   
• Businesses Adding New Products or Overseas Sites
  An existing MD-15 holder may need to apply for additional device endorsement or manufacturing-site approval, with the prescribed supporting documents and fees.

An existing licence does not automatically cover every new device or manufacturer.
 

Documents Required for CDSCO MD-14 Application

The application is supported by the documents prescribed under Rule 34 and the Fourth Schedule of the Medical Devices Rules, 2017.

The exact requirements depend on the device category, manufacturer, manufacturing site and application type.

Indian Applicant Documents

• Business constitution and authorised-signatory details.
• Qualifying manufacturing or wholesale/sale authorisation.
• Power of Attorney from the overseas manufacturer.
• Applicant and importer particulars.
• Relevant IEC information.
• Government fee payment record.
• Prescribed declarations and undertakings.

Overseas Manufacturer Documents

• Details of the legal manufacturer.
• Details of the actual manufacturing site.
• Plant Master File or applicable site documentation.
• Evidence of the manufacturing site's quality-management system.
• Relevant regulatory certificates and manufacturing authorisations.
• Free Sale Certificate or marketing authorisation, where applicable.
• Prescribed declarations and supporting evidence.

Device Technical Documents

• Device Master File.
• Device description and intended use.
• Device classification and classification rationale.
• Product specifications and applicable variants.
• Manufacturing and design information.
• Essential Principles of Safety and Performance documentation.
• Risk-management information.
• Labelling and Instructions for Use.
• Performance, safety and other evidence relevant to the device.
• IVD-specific performance information where applicable.
  
  
  Q.1. Are CE and ISO 13485 Certificates Mandatory in Every Case?
  The applicant must provide the quality and regulatory evidence required by the applicable Fourth Schedule and current CDSCO checklist.
  ISO 13485 certification, CE-related documentation and other regulatory certificates may be relevant depending on the product and manufacturing arrangements.
  It would be misleading to state that every importer must hold an identical set of CE certificates regardless of device category or country of origin.
  
  Q.2. Do Overseas Documents Need Apostille?
  The prescribed Power of Attorney must be authenticated through an accepted route.
  CDSCO's checklist recognises authentication in India by a Magistrate of the First Class, through an Indian Embassy in the country of origin, or by an equivalent authority through apostille.
  The appropriate authentication method should be confirmed for the actual documents and jurisdiction. Not every overseas document automatically requires the same authentication process.
   

How to Apply for CDSCO MD-15 Import License Online

The applicant should follow the current CDSCO medical-device application workflow and official portal instructions.

Step 1: Identify the Medical Device
Determine the product's intended use, classification, regulatory status and whether the ordinary import licence is required.

Step 2: Confirm the Overseas Manufacturing Site
Identify the legal manufacturer and actual manufacturing location.
Check whether the proposed products and sites can be supported by the required technical and regulatory records.

Step 3: Appoint an Eligible Indian Authorised Agent
Confirm the applicant's eligibility and prepare the prescribed manufacturer authorisation.

Step 4: Prepare the Technical Dossier
Compile the Plant Master File, Device Master File, quality certificates, device labels and supporting documents relevant to the application.

Step 5: Complete Portal Registration
Access the official CDSCO medical-device online application system.
Complete the applicant and IEC-related details required by the current portal workflow.

Step 6: Submit Form MD-14
Enter the relevant manufacturing-site and device information, upload the required documents and submit the application.

Step 7: Pay the Government Fee
Pay the applicable fee under the Second Schedule for the relevant device classification, site and device particulars.

Step 8: Respond to CDSCO Queries
The authority may request clarification, additional documents or further evidence.
The overseas manufacturing site may be inspected where the authority considers it necessary.

Step 9: Receive the Regulatory Decision
The Central Licensing Authority may grant the licence in Form MD-15 or reject the application with recorded reasons.

An application acknowledgement is not permission to commence regulated commercial imports.