Personal Use Import License
(Forms MD-20, MD-21)
A dedicated regulatory pathway ensuring Indian patients can legally import essential, specialized medical devices tailored to their unique health needs.
Consult Our CDSCO Experts
What Are Forms MD-20 & MD-21?
When individuals in India require specific medical devices for their personal treatment that are not commercially available or approved locally, the CDSCO provides a vital regulatory provision. This ensures patients are not denied access to life-improving or life-saving specialized technologies.
Form MD-20: Application
Submitted by the individual or their representative, requesting permission to import a limited quantity of a specific device. A valid prescription and detailed medical justification from a registered Indian medical practitioner are mandatory.
Form MD-21: License
The official CDSCO license granting legal authorization to import the device exclusively for personal use. Commercial sale, distribution, or transfer to other parties is strictly prohibited.
Why is This Pathway Vital?
Ensured Access
Provides a critical avenue to obtain niche or advanced medical technologies not widely manufactured or sold in India.
Addressing Unique Needs
Facilitates customized care for patients facing rare or complex conditions where local alternatives are insufficient.
Regulatory Safety Net
Maintains proper regulatory oversight to verify the device's necessity and safety profile, preventing misuse while prioritizing patient health.
Eligibility
Any individual residing in India who requires a specific medical device for personal treatment is eligible. However, the application must be comprehensively substantiated by a valid prescription and a detailed medical justification provided by a qualified and registered medical practitioner in India.
Compassionate Support for Patients
Navigating CDSCO portals and regulatory requirements can be overwhelming for patients and families focused on healthcare. Our consultants offer compassionate, expert support to handle the administrative burden.
- Expert dossier preparation (MD-20)
- Sugam portal navigation assistance
- Clear communication with CDSCO