What is an MD-15 License?
MD-15 license is an import license issued by the Central Drugs
Standard Control Organization (CDSCO) in India, authorizing the import of
medical devices (Class A, B, C, or D) into the country. It essentially permits
the legal sale and distribution of these imported devices
within the Indian market.
The Central Drugs Standard Control Organization (CDSCO) has
implemented a simplified system for importing medical devices into India. This
applies to all classes of medical devices, regardless of whether
they are Class A (measuring/sterile), Class B, Class C, or Class D.
Who Needs an MD-15 License?
- Indian
Importers: Companies in India that
import medical devices require an MD-15 license.
- Authorized
Indian Agents: Foreign manufacturers
must appoint an authorized Indian agent who obtains the MD-15 license on
their behalf. This agent acts as a liaison between the manufacturer and
the CDSCO.
Benefits of Obtaining an MD-15 License:
- Legality: Ensures compliance with Indian regulations for
importing and selling medical devices.
- Market
Access: Allows you to import and
commercialize your medical devices in the Indian market.
- Credibility: Demonstrates adherence to quality standards and
strengthens trust with Indian customers.
CDSCO Import License for Medical Devices (MD-14) Checklist
Summary
This checklist summarizes the documents required for applying
for an MD-14 form, which is necessary to obtain a CDSCO import license for
medical devices in India. The checklist is divided into two sections: Fresh
Application and Endorsement.
Fresh Application
- General
Documents: Covering letter, fee
challan, application form (MD-14).
- Authorization: Power of attorney from the manufacturer to the
authorized agent, along with relevant undertaking.
- Applicant
Information: Copies of relevant
licenses/registration certificates for the authorized agent and their
constitution details.
- Device
Information: Regulatory certificates,
free sale certificates/marketing authorizations, details of the
manufacturing site, and any recent inspection reports.
- Quality
Certificates: Documents demonstrating
the manufacturer’s quality management system compliance.
- Device
Master File (Manufacturer): Comprehensive
technical documentation of the medical device, including design information,
risk analysis, labeling, and performance data. This may include:
o
Executive summary
o
Device description
o
Justification for
device grouping
o
Product specifications
o
Labeling information
o
Design and
manufacturing information
o
Essential principles
checklist
o
Risk analysis and
control summary
o
Verification and
validation data
o
Biocompatibility data
(if applicable)
o
Medicinal substances
data (if applicable)
o
Biological safety data
(if applicable)
o
Sterilization
validation data (if applicable)
o
Software verification
and validation data (if applicable)
o
Animal studies data
(if applicable)
o
Stability study data
o
Clinical evidence (if
applicable)
o
Post-marketing
surveillance data
o
Batch release
certificates
Endorsement
This section applies if you are seeking an endorsement for an
existing import license. The documents required are similar to a fresh
application, but with some exceptions:
- You
only need to provide a copy of the existing import license for which the
endorsement is requested.
- Device
Master File for the product for which endorsement is applied.
- Product
registration incurs a fee, site registration is free.
Additional Notes
- All
documents submitted in a foreign language must be duly notarized and
translated into English.
- This
summary is for general information purposes only. It is recommended to
consult the official CDSCO guidelines for the latest and most accurate
requirements.
Process for Obtaining an MD-15 License (Key Points):
1. Application (Form MD-14): The authorized Indian agent submits an
online application (Form MD-14) on the CDSCO web portal.
2. Create Legal form by providing details about your device’s generic name,
intended use, materials of construction, risk classification (Class A-D), and
shelf life to ensure compliance with Indian regulations.
3. Document Upload: Upload necessary documents (check the above
checklist for necessary documents.)
4. Fee Payment: Pay the prescribed government fee as per Second
Schedule (MEDICAL DEVICE RULES- GSR 78E-IMDR 2017.
5. CDSCO Review: SLA will review all the necessary
documents.
6. MD-15 Grant (if approved): Upon successful review and potential
inspection, the CDSCO issues the MD-15 import license to the authorized agent.
Validity:
The MD-15 license is valid for 5 years from the
date of issue. However, it requires renewal every 5 years with payment of a
retention fee.
MDR Consultants: Your’ Partner in Securing
MD-15 License
Obtaining a CDSCO MD-15 import license for medical devices in
India can be a complex process. MDR (Medical Device Regulation) consultants can
be invaluable assets in navigating this process and increasing your chances of
success. Here’s how MDR consultants can play a crucial role in securing your
MD-15 license:
Expertise in Medical Device Regulations (MDR):
- Consultants
possess in-depth knowledge of the latest MDR guidelines and their
application to the MD-15 licensing process.
- We
can ensure your application adheres to all relevant regulations, avoiding
potential delays or rejections.
Streamlined Application Process& Gap assessment:
- MDR
consultants can guide you through each step of the application, from
gathering necessary documents to completing the online form (MD-14).
- We
can help ensure all documentation is accurate, complete, and formatted
correctly for CDSCO submission.
- MDR
Consultants can identify potential gaps in your application or compliance
with MDR requirements.
- We
can suggest strategies to mitigate risks and ensure your application meets
all necessary criteria.
- We
leverage our expertise and ensure transparency by providing regular status
updates and conducting post-submission checks for clients
Communication and Liaison:
- MDR
consultants can act as a bridge between you and the CDSCO, facilitating
communication and addressing any questions or concerns that may arise
during the application process.
- We
can represent you in interactions with the CDSCO, ensuring your interests
are effectively communicated.
Time and Cost Efficiency:
- By
streamlining the process and avoiding potential delays, MDR consultants
can help you obtain your MD-15 license faster.
- Their
expertise can help you avoid unnecessary costs associated with application
errors or rejections.
Additional Services:
We offer additional services such as:
o
Classification of your
medical device according to CDSCO guidelines.
o
Assistance with
labelling and instructions for use requirements.
o
Regulatory compliance
training for your staff.
