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Sat, Nov 15 2025
Raju Karn
The CDSCO’s Sugam Portal is the official online platform used for applying medical device licenses such as MD-9, MD-13, and MD-15 in India. Whether you are a manufacturer, importer, or distributor, submitting applications through mdonline / cdscomdonline requires a clear understanding of required documents, formats, and compliance rules set by the Medical Device Authority (CDSCO).
To avoid rejection, delays, or queries, it is essential to follow the correct document checklist for each form. This guide gives you a complete, updated, 2025-ready document checklist for MD-9, MD-13, and MD-15 applications on Sugam Portal, with clear explanations and professional formatting.
Before we look at the checklists, here’s a quick overview:
➡ MD-9 : License to manufacture Class A & Class B medical devices for sale or distribution (Form MD-5 → MD-9).
➡ MD-13 : License to import Class A & Class B medical devices (Form MD-14 → MD-15).
➡ MD-15 : License to import Class C & Class D medical devices (Form MD-14 → MD-15).
Each application requires a unique set of documents uploaded through the Sugam Portal.
CDSCO rejects or raises queries for very small mistakes, including:
● Mismatch in manufacturer and product details
● Missing or outdated documents
● Wrong declarations
● Unsupported technical files
● Incomplete Free Sale Certificates
Note : One mistake can delay your licensing by 2–6 weeks.
Following the correct document checklist ensures faster approvals and smooth processing.
Below is the complete document list required for MD-9 (Class A & B manufacturing license):
1. Cover Letter
▸ On company letterhead
▸ Mention purpose: "Application for MD-9 license under Medical Device Rules, 2017"
▸ Signed & stamped
2. Constitution of the Firm
Any one of the following:
▸ Partnership deed
▸ MOA & AOA
▸ Proprietorship certificate
▸ LLP agreement
3. Factory License / Pollution Control Certificate
▸ Proof that manufacturing facility is authorized to operate.
4. Site Master File (SMF)
As required under MDR, 2017. Must include:
▸ Facility Layout
▸ Quality System
▸ SOPs
▸ Equipment list
5. Quality Management System (QMS) Certificate
▸ ISO 13485:2016 — mandatory.
6. List of Medical Devices
Include:
▸ GMDN Code
▸ Risk Class
▸ Model
▸ Intended Use
7. Device Master File (DMF)
▸ Technical file containing:
▸ Product overview
▸ Design & manufacturing process
▸ Performance evaluation
▸ Risk analysis
▸ Lab testing reports
8. Plant & Machinery Details
▸ Equipment list with calibration records
▸ Manufacturing line description
9. Labeling
As per MDR labeling requirements:
▸ Manufacturer name
▸ Importer details (if applicable)
▸ UDI (if required)
▸ Storage conditions
10. Undertakings & Declarations
Mandatory declarations on:
▸ Authenticity of documents
▸ Compliance with MDR
▸ Non-hazardous products (if applicable)
The MD-13 application is used for import of Class A & B devices.
Signed by Authorized Signatory.
2. Authorized Indian Agent (AIA) Agreement
For foreign manufacturers:
• Agreement between Indian importer & foreign manufacturer
• Must mention responsibility for post-market surveillance
3. Free Sale Certificate (FSC)
Issued by the country of origin authority.
Note:
• Must be valid
• Mention the device names clearly
• Should match the application exactly
4. Device Master File (DMF)
• Provided by foreign manufacturer.
5. Plant Master File (PMF)
Includes:
• Facility standards
• Manufacturing layout
• QMS compliance
6. CE Certificate / US FDA Certificate (If applicable)
• Enhances acceptance by CDSCO.
7. QMS Certificate (ISO 13485)
Mandatory.
8. Lab Test Reports
If device requires:
• Biocompatibility
• Electrical Safety
• Performance Evaluation
9. Product Labels
As per CDSCO’s labeling rules.
10. Undertakings
• Authenticity
• Safety
• Compliance with Medical Device Rules
MD-15 is required for high-risk medical devices.
1. Application Cover Letter
2. Valid Free Sale Certificate
Must clearly mention:
➞ Device name
➞ Model
➞ Manufacturer details
3. QMS Certificate (ISO 13485:2016)
➞ More detailed for Class C & D:
➞ Chemical characterization
➞ Mechanical testing
➞ Clinical evaluation
➞ Sterilization validation
➞ Biological safety
Must include:
➞ Environmental controls
➞ Contamination control system
➞ Batch processing details
6. Clinical Evidence
If device falls under clinical requirement categories.
7. Performance Evaluation Reports
8. Risk Management File
As per ISO 14971.
9. Lab Testing
As required by Indian Medical Device Rules.
This completes the mandatory checklist for Class C & D medical device import licenses.
PSR Compliance assists with:
➤ Preparing DMF, PMF, SMF
➤ Risk classification
➤ FSC review
➤ Submission on sugam portal / mdonline
➤ Responding to CDSCO queries
➤ Complete licensing support for MD-9, MD-13, MD-15
This helps you avoid delays and get approvals faster.