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:
- Executive summary
- Device description
- Justification for device grouping
- Product specifications
- Labeling information
- Design and manufacturing information
- Essential principles checklist
- Risk analysis and control summary
- Verification and validation data
- Biocompatibility data (if applicable)
- Medicinal substances data (if
applicable)
- Biological safety data (if applicable)
- Sterilization validation data (if
applicable)
- Software verification and validation
data (if applicable)
- Animal studies data (if applicable)
- Stability study data
- Clinical evidence (if applicable)
- Post-marketing surveillance data
- 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):
- Application
(Form MD-14): The authorized Indian agent submits
an online application (Form MD-14) on the CDSCO web portal.
- 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.
- Document
Upload: Upload necessary documents (check the
above checklist for necessary documents.)
- Fee
Payment: Pay the prescribed government fee
as per Second Schedule
(MEDICAL DEVICE RULES- GSR 78E-IMDR 2017.
- CDSCO
Review: SLA will review all the necessary
documents.
- 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:
- Classification of your
medical device according to CDSCO guidelines.
- Assistance with labelling and
instructions for use requirements.
- Regulatory compliance training for your
staff.
