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India

Medical Device Registration in Armenia

Ministry of Health: 

Ministry of Health and Family Welfare

Regulatory Authority:       

Central Drugs Standard Control Organisation (CDSCO)

Medical Device Regulation:

Medical Device Rule, 2017

Official Language:   

Hindi and English

Classification:        

Class A, B, C and D

Registration Process:       

  • There are 2 types – Central Licensing Authority (CLA) and State Licensing Authority (SLA)
  • For Indian Manufacturers – They first need to obtain Manufacturer License (Form MD-03 or MD-07), followed by Product Registration as per Form 40 for notified medical devices
  • For Foreign Manufacturers – They need to apply for Registration Certificate & Import License
  • All applications are filed online via the SUGAM portal
  • Determine the device classification.
  • Appoint Indian Authorized Agent
  • Prepare all company documents and Registration Dossier
  • Submit the dossier under Form 40 to the Drugs Controller General of India (DCGI) along with fees.
  • DCGI reviews the application and sends back an inquiry letter. They may request for a technical presentation of the product.
  • Once Registration Certificate approval is obtained, apply for Import License
  • The manufacturer/Importer may start marketing the device once both the Registration Certificate and Import License in obtained.

Documents Required:      

  • Form 40
  • TR6 Challan
  • Power of Attorney
  • Schedule D
  • ISO 13485 certificate
  • CE Design certificate or Declaration of Conformity
  • Free Sales Certificate
  • Certificate of Marketability from GHTF countries
  • Other Regulatory Approvals
  • PMS report
  • Plant Master File
  • Device Master File

Post-market surveillance: 

Unexpected serious adverse event – 15 days

Legalized/Notarised Documents (if any) 

Free Sales Certificate

Applicable QMS:    

ISO 13485

Registration Timeline:      

9 – 12 months

Authorized Representative:        

Yes. Indian Authorized Agent

License Validity:     

Does not expire, unless the license retention fees is paid

Special Notes:       

Renewal processes to be initiated 9 months in advance

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