Document Checklist for MD-9, MD-13, and MD-15 Applications on Sugam Portal (2026 Guide)

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.

What Are MD-9, MD-13, and MD-15 Forms?

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

Why Document Accuracy Matters on 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● Missing or outdated documents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.

Document Checklist for MD-9 Application

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)

Document Checklist for MD-13 Application

The MD-13 application is used for import of Class A & B devices.

1. Cover Letter

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

Document Checklist for MD-15 Application

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)

4. Device Master File (DMF)

➞ More detailed for Class C & D:
➞ Chemical characterization
➞ Mechanical testing
➞ Clinical evaluation
➞ Sterilization validation
➞ Biological safety

5. Plant Master File (PMF)

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.

10. Undertakings & Declarations

This completes the mandatory checklist for Class C & D medical device import licenses.

How PSR Compliance Helps

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.

Need Help With CDSCO MD-9, MD-13 or MD-15 Registration?

Get expert assistance from PSR Compliance for smooth document preparation, filing, and approval support on the Sugam Portal.

📞 8796104190
📧 support@psrcompliance.com
📍 D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Frequently Asked Questions (FAQs)

1. What is CDSCO Sugam Portal used for?

CDSCO Sugam Portal is the official online platform used for applying, tracking, and managing medical device licenses such as MD-9, MD-13, and MD-15 in India.

2. Who needs to apply through the Sugam Portal?

Manufacturers, importers, distributors, and authorized agents dealing with medical devices in India must apply through the Sugam Portal.

3. What is MD-9 license in CDSCO?

MD-9 is the manufacturing license for Class A and Class B medical devices issued after approval of Form MD-5 application.

4. What is MD-13 license?

MD-13 is the application route used for importing Class A and Class B medical devices into India.

5. What is MD-15 license used for?

MD-15 is required for importing Class C and Class D (high-risk) medical devices in India.

6. Why is Document accuracy important in CDSCO applications?

Even small errors like mismatch in product details, missing certificates, or wrong declarations can lead to rejection or long delays.

7. Is ISO 13485 mandatory for medical device licensing?

Yes, ISO 13485 certification is mandatory for most medical device manufacturing and import license applications.

8. What is Free Sale Certificate (FSC)?

FSC is a certificate issued by the country of origin confirming that the medical device is freely sold and approved in that market.

9. How long does CDSCO approval take?

Approval time usually ranges from 4 to 12 weeks depending on document accuracy and query response time.

10. Can foreign companies apply directly for CDSCO license?

No, foreign manufacturers must appoint an Authorized Indian Agent (AIA) to apply through the Sugam Portal.