MEDICAL DEVICES REGISTRATION SERVICES

Permission/NOC to import small quantities for Personal Use

In case, someone is in need of importing small quantities of medical devices for personal use, an application in form MD 20 needs to be submitted to CDSCO through the online SUGAM portal.

CDSCO , will check the details and accordingly, decide to grant approval to import such a medical device for personal use.

Application Form: 

Application Form 

Approval Form

Risk/Class A,B,C,D

Fees

Licensing Authority

MD 20- Application for permission to import small quantity of medical devices for personal use

MD 21- Permission to import of small quantity of medical devices for personal use 

A,B,C,D

No fee 

CDSCO
Documents Required
  • Authorisation Letter from a patient 
  • ID proof of the patient 
  • ID proof of the person collecting the consignment which is imported for personal use
  • Complete Name and address of the Manufacturing Premises where the product is being manufactured.
  • Details of the Medical Device being expected to be imported.
  • Name of the Medical Device along with details of quantity required.
  • Written prescription with complete details of the recommending doctor.

Trust NKG experts to handle such a situation swiftly and efficiently.

WHY NKG FOR Medical Device Regulatory Services

NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements

    get compliant now!

    Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner, one is already engrossed in various business aspects prior to launch of a brand in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues  as well as supply chain disruption. 

    CONTACT US FOR YOUR REGULATORY NEEDS.




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