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.ly prohibited.
Why is This Process Critical?
This regulatory pathway is essential for
advancing healthcare and patient well-being:
o
Patient
Access: Provides vital
access to advanced medical devices not yet available commercially in India.
o
Ethical
Oversight: Ensures
compassionate use is conducted under rigorous ethical and regulatory
guidelines, prioritizing patient safety.
o
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:
o
Comprehensive
Application Support: We meticulously
prepare and compile all documentation for Form MD-18, ensuring accuracy and
adherence to CDSCO guidelines.
o
Clinical
Justification Review: Our team helps
refine the clinical justification, ensuring it robustly supports the device’s
critical need.
o
CDSCO
Liaison: We manage
communication, respond to queries, and proactively follow up to expedite
approval.
o
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.
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.
