Import Authorization for Investigational Devices in Government Hospitals (Forms MD-18, MD-19)

Government hospitals and statutory medical institutions in India play a vital role in providing advanced care. A crucial pathway allows them to import investigational medical devices—cutting-edge technologies not yet commercially approved in India but available in their country of origin. This enables access to potentially life-saving or disability-alleviating solutions for patients with critical, unmet medical needs.

Governed by the Medical Devices Rules, 2017, this process involves Forms MD-18 (Application) and MD-19 (License), regulated by the Central Drugs Standard Control Organization (CDSCO).

What are Forms MD-18 & MD-19?

·         These forms are the backbone of importing investigational devices for compassionate use:

·         Form MD-18: Application for License to Import Investigational Medical Devices: Submitted by the government hospital/institution to CDSCO, requesting permission to import a limited quantity of an unapproved device for specific patients facing life-threatening conditions, serious permanent disabilities, or unmet medical needs.

·         Form MD-19: License to Import Investigational Medical Device: The official CDSCO-issued license, granted upon MD-18 approval. It legally permits the import of the designated device in the approved quantity, exclusively for the identified patient(s). Commercial sale or distribution is strictly prohibited.

• strictly prohibited.

Why is This Process Critical?

·         This regulatory pathway is essential for advancing healthcare and patient well-being:

• Patient Access: Provides vital access to advanced medical devices not yet available commercially in India.
• Ethical Oversight: Ensures compassionate use is conducted under rigorous ethical and regulatory guidelines, prioritizing patient safety.
• Supporting Healthcare: Empowers government hospitals to offer state-of-the-art treatment options.

Eligibility and Key Aspects

Only Government hospitals or statutory medical institutions in India are eligible. Applications must clearly demonstrate a genuine, critical patient need.

The process involves:

• Purpose: Exclusively for treating patients with specified critical conditions.
• Application: Form MD-18, submitted by a Medical Officer with a prescription and comprehensive supporting documentation.
• Strict Usage: Devices are solely for the specified patient(s); no other use is permitted.
• Record Keeping: Mandatory detailed records of import, manufacturer, quantity, and patient information.

How MDR Consultants Can Help Your Hospital

·         Navigating the stringent requirements for importing investigational medical devices can be complex. We offer specialized expertise to streamline this vital process:

• Comprehensive Application Support: We meticulously prepare and compile all documentation for Form MD-18, ensuring accuracy and adherence to CDSCO guidelines.
• Clinical Justification Review: Our team helps refine the clinical justification, ensuring it robustly supports the device’s critical need.
• CDSCO Liaison: We manage communication, respond to queries, and proactively follow up to expedite approval.
• Compliance Assurance: We ensure every aspect of your application adheres to the Medical Devices Rules, 2017, minimizing delays.

Process Efficiency: We handle regulatory complexities, allowing your medical professionals to focus on patient care.

If your Government hospital or institution needs to import an investigational device for patient treatment, contact MDR Consultants today! We provide expert guidance to navigate the Forms MD-18 and MD-19 process efficiently and compliantly, bringing advanced medical solutions to patients in need.

Import Permission for Clinical Investigations (Forms MD-22, MD-23)

For medical device manufacturers, importers, and Clinical Research Organizations (CROs) striving to introduce innovative devices to the Indian market, conducting a clinical investigation is frequently a mandatory and critical step. This rigorous process is essential for evaluating the safety, performance, and clinical effectiveness of a new or significantly modified medical device in human subjects.

In India, this crucial activity is meticulously governed by Forms MD-22 (Application) and MD-23 (Permission) under the Medical Devices Rules, 2017. Regulated by the Central Drugs Standard Control Organization (CDSCO), obtaining these permissions is paramount for bringing safe, effective, and compliant medical technologies to patients across the nation. 

Understanding Forms MD-22 & MD-23 

These forms are the cornerstone of the regulatory framework for conducting clinical investigations of medical devices in India:

·         Form MD-22: Application for Permission to Conduct Clinical Investigation of a Medical Device.

o   This is the detailed online application submitted to the Central Licensing Authority (CLA) at CDSCO.

o   It requires comprehensive information about the applicant, the investigational device, the detailed clinical investigation plan, and a vast array of supporting documentation. Key inclusions are ethics committee approval and pre-clinical test reports.

·         Form MD-23: Permission to Conduct Clinical Investigation of a Medical Device.

o   This is the official approval document issued by the CLA (typically the Drug Controller General of India) upon successful review of the MD-22 application.

o   Form MD-23 grants the legal permission to proceed with the clinical investigation based on the submitted information, ensuring strict adherence to established regulations and scientific rigor.

These forms are crucial for ensuring that clinical investigations of medical devices are conducted both ethically and scientifically, following all established guidelines. 

Who Needs Permissions Under Forms MD-22 & MD-23? 

These forms are relevant for any entity intending to conduct clinical investigations of medical devices in India, particularly for new, unapproved, or significantly modified devices. This includes:

·         Medical Device Manufacturers: Both Indian and foreign manufacturers developing innovative devices.

·         Importers: Entities bringing in investigational devices for clinical studies in India.

·         Clinical Research Organizations (CROs): Companies conducting clinical investigations on behalf of manufacturers.

The application process is primarily conducted online through the CDSCO’s SUGAM portal, enhancing efficiency and transparency.