Investigational Devices in Govt. Hospitals
(Forms MD-18, MD-19)
Navigate the specialized regulatory pathway allowing government hospitals to import unapproved, cutting-edge medical devices for compassionate patient use.
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What Are Forms MD-18 & MD-19?
Government hospitals and statutory medical institutions in India often require access to advanced, investigational medical technologies that are not yet commercially approved in the country. The Medical Devices Rules, 2017 establishes a vital regulatory mechanism for this exact scenario, often referred to as "compassionate use."
Form MD-18: The Application
Submitted to the CDSCO by the medical institution, this form formally requests permission to import a limited, specific quantity of an unapproved device. It requires strong clinical justification for treating life-threatening conditions or serious permanent disabilities where no local alternatives exist.
Form MD-19: The License
This is the official import license granted by the CDSCO. It authorizes the institution to import the designated investigational device exclusively for the identified patient or patients. Commercial sale or distribution of devices imported under MD-19 is strictly prohibited.
Eligibility & Key Regulations
Exclusive Eligibility
Only Government hospitals or statutory medical institutions operating in India are eligible to apply through this specific pathway.
Clinical Justification
The application must be filed by a Medical Officer and accompanied by a detailed prescription and comprehensive documentation demonstrating a critical, unmet patient need.
Strict Usage Controls
The imported devices are restricted solely for treating the specified patient(s). Mandatory, detailed records must be kept regarding the import date, quantity, manufacturer, and patient details.
Clinical Investigation Permissions (Forms MD-22 & MD-23)
For manufacturers and CROs aiming to introduce innovative devices to the market, conducting full clinical investigations is often required. Forms MD-22 (Application) and MD-23 (Permission) strictly govern these studies. The application requires extensive data, including ethics committee approvals and pre-clinical test reports, all processed via the CDSCO SUGAM portal.
Explore Clinical Investigation SupportExpert Support for Hospitals
Navigating the stringent requirements for importing investigational devices under compassionate use can be overwhelming. Let our regulatory team handle the compliance so your medical professionals can focus entirely on patient care.
- Meticulous MD-18 compilation
- Clinical justification refinement
- Direct CDSCO liaison & follow-up